PHAS PhaseBio Pharmaceuticals Inc.

3.42
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Previous Close 3.42
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52 Week Low 2.6
52 Week High 8.49
Market Cap $100,352,691
Shares 29,342,892
Float 13,096,544
Enterprise Value $64,308,690
Volume 185
Av. Daily Volume 449,181
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Upcoming Catalysts

Drug Stage Catalyst Date
PB1046 - VANGARD
COVID-19 / acute respiratory distress syndrome (ARDS)
Phase 2
Phase 2
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PB1046
Pulmonary arterial hypertension (PAH)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
PB2452
Uncontrolled bleeding
Phase 3
Phase 3
Phase 3 trial initiated 1Q 2020.
PB2452
Reversal agent for ticagrelor
Phase 2b
Phase 2b
Phase 2b commencement of dosing announced October 15, 2019.

Latest News

  1. PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today announced that Chief Executive Officer Jonathan P. Mow will present a company overview at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, at 12:00 p.m. EDT.

    The event will be available via live webcast from the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical…

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today announced that Chief Executive Officer Jonathan P. Mow will present a company overview at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, at 12:00 p.m. EDT.

    The event will be available via live webcast from the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension and hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com.

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  2. Received FDA authorization to proceed with "VANGARD" clinical trial to assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS) and commenced dosing of patients

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today provided an update on corporate activities and reported second-quarter 2020 financial results.

    "Throughout the second quarter of 2020, PhaseBio made substantial progress driving our clinical development programs forward," said Jonathan P. Mow, Chief Executive Officer…

    Received FDA authorization to proceed with "VANGARD" clinical trial to assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS) and commenced dosing of patients

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today provided an update on corporate activities and reported second-quarter 2020 financial results.

    "Throughout the second quarter of 2020, PhaseBio made substantial progress driving our clinical development programs forward," said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. "We successfully launched and dosed patients in our VANGARD study, a Phase 2 clinical trial evaluating PB1046 for the prevention of development of ARDS in 210 patients hospitalized with COVID-19. Enrollment in the trial is ongoing and we expect to report results by the end of 2020."

    Mow continued, "Building on the momentum from the recent initiation of our pivotal Phase 3 trial for PB2452, our lead product candidate for the reversal of the antiplatelet effects of ticagrelor, we continue to enroll patients despite the COVID-19 pandemic, highlighting the significant unmet medical need for a reversal agent for P2Y12 antagonists such as ticagrelor. While the pandemic has created new challenges, we remain focused on executing on our strategic objectives, enrolling patients in our clinical programs, and delivering impactful medicines to people with unmet medical needs."

    Recent Pipeline and Business Highlights

    • Initiated VANGARD Phase 2 Clinical: In May 2020, PhaseBio announced that it had received U.S. FDA authorization to proceed with VANGARD. VANGARD (VIP ANalogue, in hospitalized COVID-19 patients at hiGh risk for rapid clinical deterioration and ARDS) is a multi-center, randomized, double-blind, parallel group clinical trial that will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS. Dosing of patients in the trial commenced in July 2020. Approximately 210 patients will be targeted to be enrolled at approximately 20 sites nationwide. The FDA has informed PhaseBio that positive, clearly interpretable and clinically meaningful trial results would enable the company to submit a BLA for PB1046 in this indication. More information about the Phase 2 trial is available at ClinicalTrials.gov.
    • Resumed Limited Enrollment in PB1046 Phase 2b Trial for Pulmonary Arterial Hypertension (PAH): In June 2020, PhaseBio resumed limited patient enrollment in the company's Phase 2b clinical study for the treatment of PAH. Earlier this year, PhaseBio temporarily paused enrollment of new patients in the trial as a precaution to minimize potential exposure of this patient population at high risk of serious illness from COVID-19. Certain existing sites in the United States are resuming patient screening on a limited basis, while enrollment at new sites remains on hold.
    • SFJ Financing and Co-Development Agreement Update: From execution of the Co-Development Agreement through June 30, 2020, SFJ Pharmaceuticals has funded a total of $18 million of the initial $90 million commitment under the agreement towards the development of PB2452, leaving approximately $72 million of funding available to support the PB2452 Phase 3 program through the end of 2021. PhaseBio is eligible to receive an additional $30 million of funding if specific, pre-defined clinical milestones for PB2452 are met.

    Second-Quarter 2020 Financial Results

    • Cash and cash equivalents at June 30, 2020 were $53.0 million, compared to $74.0 million at December 31, 2019. The decrease reflects cash used in operating activities.
    • Net loss for the quarter was $28.1 million, compared to a net loss of $9.2 million for prior-year period.
    • Research and development expense increased to $20.9 million, as compared to $7.8 million for the same period in 2019, driven by an increase in manufacturing, clinical and preclinical development activities related to PB2452 and PB1046.
    • General and administrative expense increased to $3.2 million, compared to $2.4 million for prior-year period, primarily due to increases in professional services, personnel, and insurance-related expenses.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of PAH and hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements.

    Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed and the success of our collaboration with SFJ, including whether we will receive all of the contemplated funding under the co-development agreement . Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

    Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which we intend to file shortly hereafter. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

    PhaseBio Pharmaceuticals, Inc.

    Condensed Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

    Three Months Ended June 30,

    Six Months Ended June 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

     

    Revenue:

    Grant revenue

    $

     

    $

    203

     

    $

    320

     

    $

    856

     

    Revenue under collaborative agreement

     

     

     

    500

     

     

     

     

    500

     

    Total revenue

     

     

     

    703

     

     

    320

     

     

    1,356

     

    Operating expenses:

    Research and development

     

    20,856

     

     

    7,781

     

     

    32,305

     

     

    13,502

     

    General and administrative

     

    3,242

     

     

    2,404

     

     

    6,401

     

     

    4,720

     

    Total operating expenses

     

    24,098

     

     

    10,185

     

     

    38,706

     

     

    18,222

     

    Loss from operations

     

    (24,098

    )

     

    (9,482

    )

     

    (38,386

    )

     

    (16,866

    )

    Other (expense) income

     

    (4,044

    )

     

    250

     

     

    (4,661

    )

     

    341

     

    Net loss

    $

    (28,142

    )

    $

    (9,232

    )

    $

    (43,047

    )

    $

    (16,525

    )

     

    Net loss per common share, basic and diluted

    $

    (0.98

    )

    $

    (0.33

    )

    $

    (1.50

    )

    $

    (0.63

    )

     

    Weighted average common shares outstanding, basic and diluted

     

    28,805,238

     

     

    27,932,610

     

     

    28,789,256

     

     

    26,224,986

     

    PhaseBio Pharmaceuticals, Inc.

    Condensed Balance Sheets

    (in thousands)

    (unaudited)

     

    June 30,

    2020

    December 31,

    2019

    Assets:

    Cash and cash equivalents

    $

    53,025

    $

    74,025

    Other receivables, prepaid expenses and other current assets

     

    10,716

     

    4,798

    Property and equipment, net

     

    4,876

     

    1,924

    Operating lease right-of-use assets

     

    2,136

     

    1,715

    Other non-current assets

     

    57

     

    32

    Total assets

    $

    70,810

    $

    82,494

     

    Liabilities and stockholders' equity:

    Current portion of long-term debt

    $

    5,015

    $

    2,378

    Accounts payable, accrued expenses and other current liabilities

     

    12,787

     

    6,101

    Long-term debt, net

     

    9,768

     

    12,326

    Operating lease liabilities, net

     

    1,773

     

    1,508

    Development derivative liability

     

    14,686

     

    Other long-term liabilities

     

    388

     

    203

    Stockholders' equity

     

    26,393

     

    59,978

    Total liabilities and stockholders' equity

    $

    70,810

    $

    82,494

     

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  3. PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today announced that Chief Executive Officer Jonathan P. Mow and other members of the management team will participate in a fireside chat at the upcoming William Blair Biotech Focus Conference 2020 on Thursday, August 6, at 2:00 p.m. EDT.

    The event will be available via live webcast from the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc.

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases, today announced that Chief Executive Officer Jonathan P. Mow and other members of the management team will participate in a fireside chat at the upcoming William Blair Biotech Focus Conference 2020 on Thursday, August 6, at 2:00 p.m. EDT.

    The event will be available via live webcast from the "Events and Presentations" page of the "Investors" section of the company's website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension and hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com.

    View Full Article Hide Full Article
  4. Recently launched Phase 2 "VANGARD" trial to assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome

    PB1046, a long-acting analog of vasoactive intestinal peptide (VIP), has the potential to modulate several proinflammatory cytokines that are believed to be key drivers of the inflammatory response to COVID-19

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that it has dosed the first patient in VANGARD, a potentially pivotal Phase 2 clinical trial to evaluate PB1046 as a treatment for…

    Recently launched Phase 2 "VANGARD" trial to assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome

    PB1046, a long-acting analog of vasoactive intestinal peptide (VIP), has the potential to modulate several proinflammatory cytokines that are believed to be key drivers of the inflammatory response to COVID-19

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that it has dosed the first patient in VANGARD, a potentially pivotal Phase 2 clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS). PB1046 is a novel, once-weekly, subcutaneously-injected VIP receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems. VIP is a neurohormone known to have anti-inflammatory, antifibrotic and potent bronchodilatory and immunomodulatory effects in the respiratory system. Specifically, VIP has been shown to regulate proinflammatory cytokines including TNF-α, IFN-γ, IL-12, IL-17A and IL-6. In animal models, treatment with VIP peptide prevented acute lung injury and inhibited cytokine-mediated inflammatory responses that are characteristic of ARDS.

    "Having novel treatment options that could help prevent COVID-19 patients from requiring ventilator support is an important step in fighting against this global pandemic," said Dr. Andrew Catanzaro, an investigator in the VANGARD trial and head of Infectious Disease Medicine at Adventist Healthcare White Oak Medical Center in Silver Spring, Maryland. "The inflammatory response to COVID-19 has been an exceptionally challenging aspect of managing infected patients, and those who require ventilator support have an especially poor prognosis. The PB1046 mechanism of action has the potential to mitigate proinflammatory cytokines thought to be key drivers causing rapid decline in lung function observed in more severe COVID-19 cases. Through science, and with partners like PhaseBio, we hope to discover agents that will be active for the inflammatory response and this is another important step in this process."

    The VANGARD trial (VIP ANalogue, in hospitalized COVID-19 patients at hiGh risk for rapid clinical deterioration and ARDS) is a multi-center, randomized, double-blind, parallel group clinical trial that is assessing the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS. Approximately 210 patients will be targeted to be enrolled at approximately 20 sites nationwide. The primary endpoint in the trial measures days alive and free of respiratory failure.

    "We are pleased that the initial patient has been enrolled in our potentially pivotal Phase 2 trial of PB1046 in hospitalized COVID-19 patients who are facing rapid deterioration of lung function," said Jonathan Mow, Chief Executive Officer, PhaseBio Pharmaceuticals. "Physicians are in desperate need of new options to treat COVID-19 patients, and PhaseBio is working to be a key part of the solution to this global pandemic. To have initiated the VANGARD trial in the midst of a pandemic that has severely impacted the global healthcare system in an unprecedented manner is a testament to the resolve and determination of the PhaseBio team, trial investigators and our network of advisors. We remain on track to report trial results late in the fourth quarter of 2020."

    As the COVID-19 pandemic unfolded around the world, PhaseBio moved rapidly to develop a trial protocol and submit an IND application to the FDA to evaluate the potential of PB1046 to help COVID-19 patients at high risk of progressing to ARDS. PhaseBio received FDA clearance in May to initiate the VANGARD trial and, subject to the pace of enrollment and any further impacts from the COVID-19 pandemic itself, the Company is targeting to report results late in the fourth quarter of 2020. Based on feedback from the FDA, PhaseBio believes that positive, clearly interpretable and clinically meaningful results from this trial may enable PhaseBio to submit a Biologics License Application.

    More information about the VANGARD phase 2 trial is available at ClinicalTrials.gov, using the identifier NCT04433546.

    About PB1046

    PB1046, a novel, subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, is a recombinant fusion protein composed of VIP and PhaseBio's proprietary elastin-like polypeptide (ELP) biopolymer. Based on the pharmacokinetic profile of PB1046 observed in clinical trials, the fusion of VIP to ELP results in both a prolonged absorption profile and a longer circulating half-life, enabling once-weekly dosing.

    PB1046 is in Phase 2 development for the treatment of pulmonary arterial hypertension (PAH) and in a Phase 2 clinical trial for the treatment of hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS, which the Company refers to as the VANGARD trial. PhaseBio expects to report initial data from the VANGARD trial in the fourth quarter of 2020, while results from the Phase 2b trial in PAH are expected to be reported in 2021. To date, PB1046 has been administered to more than 70 patients with hypertension or a history of cardiovascular disease in three Phase 1/2 clinical trials conducted in the United States. The FDA has granted PB1046 orphan drug designation for the treatment of pulmonary arterial hypertension (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with dystrophinopathies.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension and hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our VANGARD trial of PB1046 for the treatment of COVID-19 patients at high risk for rapid clinical deterioration and ARDS, or other product candidates in our pipeline, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, including whether the FDA will accept the results of VANGARD for submission of a Biologics License Application, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

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  5. PhaseBio receives clearance of IND application from U.S. FDA under Coronavirus Treatment Acceleration Program (CTAP)

    "VANGARD" trial will assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome

    Based on FDA feedback, PhaseBio believes that positive, clearly interpretable and clinically meaningful trial results may enable PhaseBio to submit a Biologics License Application

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced FDA authorization to proceed with VANGARD, a potentially pivotal…

    PhaseBio receives clearance of IND application from U.S. FDA under Coronavirus Treatment Acceleration Program (CTAP)

    "VANGARD" trial will assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome

    Based on FDA feedback, PhaseBio believes that positive, clearly interpretable and clinically meaningful trial results may enable PhaseBio to submit a Biologics License Application

    PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced FDA authorization to proceed with VANGARD, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).

    PB1046 is a novel, once-weekly, subcutaneously-injected vasoactive intestinal peptide (VIP) receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems. VIP is a neurohormone known to have anti-inflammatory, antifibrotic, inotropic, lusitropic and vasodilatory effects and several cardiopulmonary disorders are associated with alterations in levels of VIP or its receptors, VPAC1 and VPAC2. Importantly, VIP has also been observed to have potent bronchodilatory and immunomodulatory effects in the respiratory system. Specifically, VIP has been shown to regulate proinflammatory cytokines including TNF-α, IFN-γ, IL-12, IL-17A and IL-6. In animal models, treatment with VIP peptide prevented acute lung injury and inhibited cytokine-mediated inflammatory responses that are characteristic of ARDS.

    "Based on the mechanism of action, the well-documented clinical profile of PB1046, a once-weekly-dosing regimen that eliminates the need for continuous IV infusions required to administer VIP peptide, and evidence of activity of VIP peptide in ARDS, we decided to pursue a rigorous, double-blind randomized trial to evaluate PB1046 as a treatment for COVID-19 patients at high risk of progressing to acute respiratory distress syndrome," said Jonathan Mow, Chief Executive Officer at PhaseBio. "PhaseBio moved very rapidly to develop a study protocol and submit an investigational new drug application (IND) to the FDA. I would like to thank the team at PhaseBio, our network of advisors and investigators and the FDA for the collaborative effort to launch this trial in such an expedited manner."

    The VANGARD trial (VIP ANalogue, in hospitalized COVID-19 patients at hiGh risk for rapid clinical deterioration and ARDS) is a multi-center, randomized, double-blind, parallel group clinical trial that will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS. Approximately 210 patients will be targeted to be enrolled at approximately 20 sites nationwide. The primary endpoint will measure days alive and free of respiratory failure.

    Having received FDA clearance to initiate the VANGARD trial, PhaseBio expects to begin dosing patients by the end of June. Subject to the pace of enrollment and any further impacts from the COVID-19 pandemic, PhaseBio is targeting to report trial results late in the fourth quarter of 2020. Based on feedback from the FDA, PhaseBio believes that positive, clearly interpretable and clinically meaningful results from this trial may enable PhaseBio to submit a Biologics License Application.

    "Physicians are in desperate need of new options to treat COVID-19 patients facing rapid deterioration of lung function and before progressing to a ventilator," said John Lee, M.D., Ph.D., Chief Medical Officer at PhaseBio. "The impact of the pandemic on the global healthcare system has been overwhelming during the past few months and the importance of new treatment options that could help reduce this burden cannot be overstated. Based on what we've learned thus far about COVID-19 and acute respiratory distress syndrome, the prognosis for patients who ultimately require ventilator support is exceptionally poor. Early mitigation by PB1046 of the effects of inflammatory cytokines that can cause acute lung injury, is a promising strategy that could prevent patients from declining to the point where they require mechanical ventilation and help alleviate the strain on critical care infrastructure that we're witnessing."

    About PB1046

    PB1046, a novel, subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, is a recombinant fusion protein composed of VIP and PhaseBio's proprietary elastin-like polypeptide (ELP) biopolymer. Based on the pharmacokinetic profile of PB1046 observed in clinical trials, the fusion of VIP to ELP results in both a prolonged absorption profile and a longer circulating half-life, enabling once-weekly dosing.

    PB1046 is in Phase 2 development for the treatment of pulmonary arterial hypertension (PAH) and in a Phase 2 clinical trial for the treatment of hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome, which the Company refers to as the VANGARD trial. PhaseBio expects to report initial data from the VANGARD trial in the fourth quarter of 2020, while results from the Phase 2b trial in PAH are expected to be reported in 2021. To date, PB1046 has been administered to more than 70 patients with hypertension or a history of cardiovascular disease in three Phase 1/2 clinical trials conducted in the U.S., with no drug-related serious adverse events reported to date. The U.S. Food and Drug Administration has granted PB1046 orphan drug designation for the treatment of pulmonary arterial hypertension (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with dystrophinopathies.

    About PhaseBio

    PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension and acute respiratory distress syndrome; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide (ELP) technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug-development opportunities.

    PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our VANGARD trial of PB1046 for the treatment of COVID-19 patients at high risk for rapid clinical deterioration and ARDS, or other product candidates in our pipeline, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, including whether the FDA will accept the results of VANGARD for submission of a Biologics License Application, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

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