SPRO Spero Therapeutics Inc.

9.53
+0.14  (+1%)
Previous Close 9.39
Open 9.36
52 Week Low 5.25
52 Week High 14.483
Market Cap $247,184,766
Shares 25,937,541
Float 21,724,213
Enterprise Value $181,383,765
Volume 146,010
Av. Daily Volume 328,592
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Drug Pipeline

Drug Stage Notes
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)
Phase 3
Phase 3
Phase 3 data released September 8, 2020 showed non-inferiority versus intravenous ertapenem.
SPR720
Nontuberculous mycobacterial (NTM) pulmonary disease
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2020.
SPR206
MDR Gram-negative bacterial infections
Phase 1
Phase 1
Phase 1 BAL trial to be initiated 1H 2021.
SPR741
Healthy Volunteers (safety trial)
Phase 1b
Phase 1b
Phase 1b top-line data released May 23, 2018 - supportive of further development.

Latest News

  1. CAMBRIDGE, Mass., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced it will host a key opinion leader (KOL) call on oral tebipenem HBr for the treatment of complicated urinary tract infections on Wednesday, September 30, 2020 at 11:30 a.m. Eastern Time.

    The call will feature a presentation by KOL Keith Kaye, MD, MPH, University of Michigan Medical School, who will discuss the current treatment landscape and unmet medical need in complicated urinary tract infections (cUTI). Dr. Kaye will…

    CAMBRIDGE, Mass., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced it will host a key opinion leader (KOL) call on oral tebipenem HBr for the treatment of complicated urinary tract infections on Wednesday, September 30, 2020 at 11:30 a.m. Eastern Time.

    The call will feature a presentation by KOL Keith Kaye, MD, MPH, University of Michigan Medical School, who will discuss the current treatment landscape and unmet medical need in complicated urinary tract infections (cUTI). Dr. Kaye will be available to answer questions during the call.

    Spero's management team will also discuss the recently announced positive top-line data from Spero's ADAPT-PO Phase 3 clinical trial of oral tebipenem HBr for the treatment of cUTI and acute pyelonephritis (AP). The ADAPT-PO trial met its primary endpoint of demonstrating that oral tebipenem HBr is statistically non-inferior to intravenous ertapenem, the most commonly used carbapenem for the treatment of cUTI and AP.

    Wednesday, September 30, 2020 @ 11:30 a.m. Eastern Time

    Domestic: 1-877-705-6003
    International: 1-201-493-6725
    Conference ID: 13709233
    Webcast: Click Here for Webcast
       

    A webcast of the presentation may also be accessed through the Spero Therapeutics' website (www.sperotherapeutics.com) on the "Events and Presentations" page under the "Investors and Media" tab.  A replay of the presentation will be archived on the website for 90 days following the conclusion of the event.

    About Dr. Keith Kaye:

    Dr. Kaye is a Professor of Medicine in the Division of Infectious Diseases and Department of Medicine at University of Michigan Medical School. He is the Director of Research for the Division of Infectious Diseases.

    He has devoted his career to the prevention and effective management of healthcare-associated infections. In addition to serving in a variety of quality improvement and administrative roles in infection prevention, antimicrobial stewardship, and quality and patient safety, he has served on national and international clinical guidelines committees.

    In addition to his clinical work, Dr. Kaye's research interests include the development of antimicrobial resistance, particularly among gram-negative organisms; prevention of healthcare associated infections; management of hospital-acquired infections in the elderly; and innovative approaches to antimicrobial stewardship. He has a long and consistent record of federal funding for research pertaining to management and prevention of multi-drug resistant organisms and healthcare-associated infections, including groundbreaking clinical trials.

    Dr. Kaye received his medical degree from the University of Pennsylvania and completed his Internal Medicine residency and Infectious Diseases fellowship at Beth Israel Deaconess Medical Center in Boston, MA. During fellowship, Dr. Kaye earned a Masters in Public Health from the Harvard School of Public Health. Dr. Kaye has authored over 300 peer-reviewed articles and 20 book chapters and has presented original research at national and international conferences. Dr. Kaye is Past President of the Society for Health Epidemiology of America (SHEA). He is a recognized expert in healthcare epidemiology and antimicrobial resistance and has been invited to speak on these topics at venues throughout the world.

    About Tebipenem HBr

    Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero's novel investigational oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-lactam class marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections. Tebipenem HBr is being developed for the treatment of complicated urinary tract infections, including acute pyelonephritis. The Company expects that the favorable ADAPT-PO clinical trial results, once finalized, will support completion of a New Drug Application submission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr in the second quarter of 2021. If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI and AP.

    About Spero Therapeutics

    Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.

    Spero's lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis.

    Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

    Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.

    For more information, visit https://sperotherapeutics.com.

    Forward-Looking Statements

    This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Spero's ability to timely complete related Phase 1 trials for NDA submission, taking into account the possible effects of the COVID-19 pandemic; Spero's need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Spero's product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero's ability to retain key personnel and to manage its growth; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero's views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero's views as of any date subsequent to the date of this press release.

    Spero Investor and Media Contact:

    Sharon Klahre

    Senior Director, Investor Relations

    857-242-1547

    Primary Logo

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  2. CAMBRIDGE, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that Ankit Mahadevia, M.D., President and Chief Executive Officer of Spero Therapeutics, will provide a corporate update at the following investor conferences in September 2020:

    • Cantor Virtual Global Healthcare Conference on Thursday, September 17 at 1:20 PM ET
    • Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 23, 2020 at 9:10 AM ET

    Webcasts of the presentations may be accessed…

    CAMBRIDGE, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that Ankit Mahadevia, M.D., President and Chief Executive Officer of Spero Therapeutics, will provide a corporate update at the following investor conferences in September 2020:

    • Cantor Virtual Global Healthcare Conference on Thursday, September 17 at 1:20 PM ET
    • Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 23, 2020 at 9:10 AM ET

    Webcasts of the presentations may be accessed through Spero Therapeutics' website (www.sperotherapeutics.com) on the "Events and Presentations" page under the "Investors and Media" tab.  Replays of the presentations will be archived on the website for 90 days following the conclusion of each event.

    About Spero Therapeutics

    Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.

    Spero's lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections.  In September 2020, Spero announced positive topline results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. 

    Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

    Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.

    For more information, visit https://sperotherapeutics.com.

    Spero Investor and Media Contact:

    Sharon Klahre

    Senior Director, Investor Relations

    857-242-1547

    Primary Logo

    View Full Article Hide Full Article
  3. CAMBRIDGE, Mass., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced the pricing of its previously announced underwritten public offering of 4,785,000 shares of its common stock and 3,215,000 shares of its non-voting Series D Convertible Preferred Stock. The public offering price of each share of common stock and each share of Series D Convertible Preferred Stock is $10.00. 

    The gross proceeds to Spero from this offering are expected to be $80.0 million, before deducting underwriting…

    CAMBRIDGE, Mass., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced the pricing of its previously announced underwritten public offering of 4,785,000 shares of its common stock and 3,215,000 shares of its non-voting Series D Convertible Preferred Stock. The public offering price of each share of common stock and each share of Series D Convertible Preferred Stock is $10.00. 

    The gross proceeds to Spero from this offering are expected to be $80.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Spero. All of the securities in the offering are being sold by Spero. In addition, Spero has granted the underwriters in the offering a 30-day option to purchase up to an additional 1,200,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about September 15, 2020, subject to customary closing conditions.

    The shares of Series D Convertible Preferred Stock are convertible on a one-to-one basis into shares of common stock, provided that the conversion will be prohibited if, as a result, the holder of the Series D Convertible Preferred Stock and its affiliates would own more than 9.99% of the total number of shares of common stock then outstanding.

    Spero intends to use the net proceeds from the offering, together with its existing cash and cash equivalents and committed funding from its existing BARDA contract and other non-dilutive funding commitments, to fund the advancement of tebipenem HBr through the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), the ongoing development of its pipeline products, and for working capital and other general corporate purposes.

    Cowen and Company, LLC, Evercore Group, L.L.C. and Cantor Fitzgerald & Co. are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. is acting as lead manager for the offering, and H.C. Wainwright & Co., LLC is acting as co-manager for the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to the offering was filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at ; Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor New York, New York 10022; Email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Spero

    Spero is a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.

    Forward-Looking Statements

    Investors are cautioned that statements in this press release regarding the completion of the public offering, the anticipated net proceeds from the offering, Spero's intended use of proceeds from the offering and Spero's future development plans for its product candidates and the timing and costs thereof constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the public offering and the uncertainties inherent in the research and clinical development process. There can be no assurance that Spero will be able to complete the public offering. Additional information on risks facing Spero can be found under the heading "Risk Factors" in Spero's periodic reports, including its annual report on Form 10-K and quarterly reports on Form 10-Q, and in the preliminary prospectus related to this offering filed with the SEC, and the final prospectus related to this offering to be filed with the SEC, each available on the SEC's web site at www.sec.gov. Spero expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Spero Investor and Media Contact:

    Sharon Klahre

    Senior Director, Investor Relations

    857-242-1547

    Primary Logo

    View Full Article Hide Full Article
  4. CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced that it has commenced an underwritten public offering of 8,000,000 shares of common stock in the aggregate, consisting of an offering of shares of common stock (the "common stock offering") and shares of non-voting Series D Convertible Preferred Stock with each share of Series D Convertible Preferred Stock being convertible into 1,000 shares of common stock. All of the securities in the offering will be sold by Spero…

    CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced that it has commenced an underwritten public offering of 8,000,000 shares of common stock in the aggregate, consisting of an offering of shares of common stock (the "common stock offering") and shares of non-voting Series D Convertible Preferred Stock with each share of Series D Convertible Preferred Stock being convertible into 1,000 shares of common stock. All of the securities in the offering will be sold by Spero. In addition, Spero expects to grant the underwriters in the common stock offering a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price, less the underwriting discounts and commissions.

    Spero intends to use the net proceeds from the offering, together with its existing cash and cash equivalents and committed funding from its existing BARDA contract and other non-dilutive funding commitments, to fund the advancement of tebipenem HBr through the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), through the NDA approval process and, if approved by the FDA, through its initial commercialization, the ongoing development of its pipeline products, and for working capital and other general corporate purposes.

    Cowen and Company, LLC, Evercore Group, L.L.C. and Cantor Fitzgerald & Co. are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. is acting as lead manager for the offering, and H.C. Wainwright & Co., LLC is acting as co-manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at ; Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor New York, New York 10022; Email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Spero

    Spero is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections and rare diseases.

    Forward-Looking Statements

    Investors are cautioned that statements in this press release regarding the intention, completion, timing and option relating to the proposed public offering, the intended use of proceeds from the offering and Spero's future development plans for its product candidates and the timing and costs thereof constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the uncertainties inherent in the research and clinical development process. There can be no assurance that Spero will be able to complete the proposed public offering. Additional information on risks facing Spero can be found under the heading "Risk Factors" in Spero's periodic reports, including its annual report on Form 10-K and quarterly reports on Form 10-Q, and in the preliminary prospectus relating to the proposed offering to be filed with the SEC, each available on the SEC's web site at www.sec.gov. Spero expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Spero Investor Contact:

    Sharon Klahre

    Director, Investor Relations

    857-242-1547

    Primary Logo

    View Full Article Hide Full Article
  5. Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis

    Well-tolerated with comparable safety profile to intravenous ertapenem

    Spero intends to complete NDA submission for U.S. regulatory approval of tebipenem HBr in the second quarter of 2021

    Management to host conference call and live webcast at 8:00 a.m. EDT today

    CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet medical need areas involving multidrug-resistant…

    Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis

    Well-tolerated with comparable safety profile to intravenous ertapenem

    Spero intends to complete NDA submission for U.S. regulatory approval of tebipenem HBr in the second quarter of 2021

    Management to host conference call and live webcast at 8:00 a.m. EDT today

    CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet medical need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced positive topline results from ADAPT-PO, the pivotal Phase 3 clinical trial evaluating Spero's oral antibiotic candidate, tebipenem HBr, for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). Topline data from the trial demonstrate that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP.

    The global Phase 3 ADAPT-PO clinical trial evaluated the safety and efficacy of oral tebipenem HBr versus IV ertapenem for the treatment of adults with cUTI or AP. Results demonstrate that tebipenem HBr was non-inferior compared to ertapenem with respect to the trial's primary endpoint, overall response (combined clinical cure plus microbiologic eradication) at the test-of-cure (TOC) visit in the microbiological-intent-to-treat (micro-ITT) population.

    • The favorable overall response rates at TOC were 58.8% (264/449) versus 61.6% (258/419) for tebipenem HBr and ertapenem, respectively (treatment difference, -3.3%; 95% confidence interval [CI]: -9.7, 3.2; -12.5% NI margin).
    • Clinical cure rates at TOC were high (>93%) in both treatment groups.
    • Overall response rates were consistent across key subgroups of interest, including age, baseline diagnosis, and presence of bacteremia. Per pathogen microbiological response was balanced across treatment groups for most prevalent uropathogens. 

    "The results of ADAPT-PO are truly exciting and welcome news for the medical community and for the millions of U.S. patients suffering from cUTI and AP annually," said Dr. Keith Kaye, Director of Research in the Division of Infectious Diseases at the University of Michigan Medical School. "Due to the increasing prevalence of antibiotic-resistant bacteria, many patients with cUTI now receive intravenous antibiotics as their only available treatment option. The much-anticipated data from this head-to-head comparison against an IV standard-of-care carbapenem antibiotic suggest that in many instances oral, outpatient treatment of these complicated bacterial infections is a viable option."

    Comparative safety data from the 1,372 hospitalized adult patients who enrolled in the trial suggest that tebipenem HBr was well-tolerated, with a safety profile similar to that of ertapenem.

    • Treatment emergent adverse events (TEAEs) were reported in approximately 26% of patients in both treatment groups.
    • The most commonly reported TEAEs in both treatment groups were diarrhea (5.0%) and headache (3.8%).
    • Serious TEAEs were infrequent (1.3% for tebipenem HBr vs. 1.7% for ertapenem) and no deaths were reported in the trial.
    • Three Clostridioides difficile‑associated TEAEs were observed in the ertapenem group, while none were observed in the tebipenem HBr group.    

    Dr. Ankit Mahadevia, Chief Executive Officer of Spero Therapeutics, commented, "The ADAPT-PO trial is a landmark trial that is the first ever to test an all oral regimen against an all IV regimen for the treatment of cUTI.  We are thrilled to announce positive ADAPT-PO results that we believe demonstrate the value of tebipenem HBr for healthcare providers, payers and patients.  These results bring us one step closer to delivering a new oral therapeutic option that could potentially address an expanding unmet need for patients with cUTI and AP. If approved by the FDA, tebipenem HBr would be the first oral cUTI drug to earn approval in 26 years, which would be an important achievement given the high levels of resistance to currently available oral therapies. We want to express our gratitude to the patients and investigators who participated in the trial."

    Emerging data from the tebipenem HBr program, including the ADAPT-PO clinical trial results, will be presented in detail at future scientific meetings and in publications. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration (FDA) for the treatment of cUTI, which may result in expedited review and an option for rolling submission of a New Drug Application (NDA). Spero intends to initiate a rolling NDA submission and anticipates completing the NDA submission to the FDA for tebipenem HBr in the second quarter of 2021.

    Conference Call and Webcast

    Spero will host a conference call and webcast today at 8:00 a.m. EDT. To access the call, please dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and refer to conference ID 13709990. The conference call will also be webcast live and a link to the webcast can be accessed (here) and also on Spero's website at www.sperotherapeutics.com in the "Investors and Media" section under "Events and Presentations." An archived webcast will be available on Spero's website for 30 days following the presentation.

    About ADAPT-PO

    The global, randomized, placebo-controlled ADAPT-PO Phase 3 clinical trial evaluated the safety and efficacy of tebipenem HBr in hospitalized adult patients with cUTI or AP. Patients were randomized (1:1) to receive tebipenem HBr (600 mg) orally every 8 hours, or ertapenem (1 g) IV every 24 hours, for a total of 7 to 10 days. Patients with concurrent bacteremia received up to 14 days of therapy. The primary endpoint was the overall response, defined as the combination of clinical cure and microbiological eradication of the causative pathogen(s), at the test-of-cure (TOC) visit (Day 19 ±2 days) and was assessed in the micro-ITT population. The primary analysis and assessment of non-inferiority was evaluated using a pre-specified -12.5% non-inferiority (NI) margin.  This NI margin was a modification of the original NI margin of -10% that was discussed with the FDA because of concern that the COVID-19 pandemic could have an adverse effect on the trial. As a result, the NI margin was modified prior to database lock from the original NI margin.  However, as noted by the lower bound of the 95% confidence interval (-9.7), the trial also achieved success according to the original -10% NI margin.  

    About Tebipenem HBr

    Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero's novel investigational oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-lactam class marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections. Tebipenem HBr is being developed for the treatment of complicated urinary tract infections, including acute pyelonephritis. The Company expects that the favorable ADAPT-PO clinical trial results, once finalized, will support completion of a New Drug Application submission to the FDA in the second quarter of 2021. If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI and AP.

    About Complicated Urinary Tract Infection (cUTI)

    In 2007, in the United States alone, there were an estimated 10.5 million office visits for urinary tract infection (UTI) symptoms and 2-3 million emergency department visits. Most cases of cUTI and acute pyelonephritis are caused by Enterobacteriaceae, with Escherichia coli being the most common pathogen in the majority of infections across care settings.  According to the Centers for Disease Control (CDC), drug-resistant Enterobacteriaceae, or commonly called extended-spectrum beta lactamase (ESBL) producing Enterobacteriaceae, is considered to be one of the most serious antibiotic-resistant bacterial threats in the United States.  Antimicrobial resistance rates across most U.S. regions to fluoroquinolones, the most commonly used antibiotic for UTI, are >30% among Escherichia coli.  Currently, there are few oral options to treat these patients.  There is a need for strategies to avoid preventable cUTI-related inpatient and emergency department visits and potentially an opportunity to shift site of care for a proportion of hospitalized patients with cUTIs.  

    Tebipenem HBr Research Support

    This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800015C. 

    About Spero Therapeutics

    Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.

    Spero's lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is anticipated to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections.

    Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

    Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.

    For more information, visit https://sperotherapeutics.com.

    Forward-Looking Statements

    This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Spero's ability to timely complete related Phase 1 trials for NDA submission, taking into account the possible effects of the COVID-19 pandemic; Spero's need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Spero's product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero's ability to retain key personnel and to manage its growth; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero's views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero's views as of any date subsequent to the date of this press release.

    Spero Investor and Media Contact:

    Sharon Klahre

    Senior Director, Investor Relations

    857-242-1547

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