ACRS Aclaris Therapeutics Inc.

2.53
-0.01  -0%
Previous Close 2.54
Open 2.56
52 Week Low 0.7
52 Week High 3.34
Market Cap $108,396,241
Shares 42,844,364
Float 40,802,546
Enterprise Value $51,464,240
Volume 710,009
Av. Daily Volume 636,287
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Upcoming Catalysts

Drug Stage Catalyst Date
ATI-450
Rheumatoid arthritis (RA)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
ATI-1777
Atopic dermatitis
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 2H 2020.
ATI-450
COVID-19
Phase 2a
Phase 2a
Phase 2a dosing commenced August 2020.
A-101 THWART-1 and THWART-2
Common warts (verruca vulgaris)
Phase 3
Phase 3
Phase 3 data met all endpoints - September 16, 2019 and October 24, 2019.
ATI-502
Androgenetic alopecia (AGA) - Hair loss
Phase 2
Phase 2
Partner required to further development.
ATI-501 (AUAT-201 Oral)
Alopecia areata
Phase 2
Phase 2
Phase 2 data met primary endpoint and some secondary endpoints - July 30, 2019. Partner required for further development.
ATI-502 (VITI-201 Topical)
Vitiligo
Phase 2
Phase 2
Development to be discontinued - noted August 8, 2019.
ATI-502 (ATI-50002-AA-201) - dose ranging
Alopecia areata
Phase 2
Phase 2
Phase 2 data did not meet primary endpoint - June 26, 2019.
ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
Approved
Approved
Approval announced December 15, 2017.

Latest News

  1. WAYNE, Pa., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference. On Tuesday, September 15, 2020 at 12:30 p.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will present a company overview. Management will be available September 15th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.
       
    • Cantor Virtual Global Healthcare Conference. On Thursday, September 17, 2020 at 10:40…

    WAYNE, Pa., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference. On Tuesday, September 15, 2020 at 12:30 p.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will present a company overview. Management will be available September 15th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.

       
    • Cantor Virtual Global Healthcare Conference. On Thursday, September 17, 2020 at 10:40 a.m. ET., Dr. Walker will participate in a fireside chat. Management will be available September 17th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.

    A live audio webcast of each presentation may be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. An archived version of each webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Aclaris Contact 

     

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  2.  First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
     First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
     Clinical Trial of ATI-1777, an Investigational "Soft" Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis

    WAYNE, Pa., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and…

     First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
     First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
     Clinical Trial of ATI-1777, an Investigational "Soft" Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis

    WAYNE, Pa., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and business highlights.

    "As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times," said Dr. Neal Walker, President and CEO of Aclaris. "In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans."

    R&D Highlights:

    The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

    • ATI-450, an investigational oral small molecule MK2 inhibitor compound:
      • ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
        • This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
      • ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
      • IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
        • The first subject was dosed in August 2020.
    • ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
      • Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
      • ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
    • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
      • Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.

    Business Development Highlights:

    • Aclaris continues to pursue strategic alternatives, including seeking partners for:
      • A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
      • ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
      • ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    Financial Highlights:

    Liquidity and Capital Resources

    As of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of $68.1 million compared to $75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was $10.8 million and $17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

    Second Quarter 2020 and Year-to-Date Financial Results

    • The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations.
    • Net loss was $11.6 million for the second quarter of 2020, compared to $49.9 million for the second quarter of 2019, and was $27.2 million for the six months ended June 30, 2020, compared to $87.4 million for the six months ended June 30, 2019.
    • Total costs and expenses from continuing operations for the second quarter of 2020 were $13.4 million, compared to $44.5 million for the second quarter of 2019, and were $30.3 million for the six months ended June 30, 2020, compared to $72.8 million for the six months ended June 30, 2019.
      • Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of $3.3 million, compared to $4.6 million in the prior year period. 
      • Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of $6.8 million, compared to $8.9 million in the prior year period.
      • Recorded a non-cash goodwill impairment charge of $18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020.
    • R&D expenses were $6.5 million and $15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $17.5 million and $37.2 million for the quarter and six months ended June 30, 2019, respectively.
      • The quarter-over-quarter decrease of $11.1 million was primarily the result of the substantial completion of Aclaris' various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
    • General and administrative expenses were $5.6 million and $11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to $7.5 million and $14.9 million for the quarter and six months ended June 30, 2019, respectively.
      • The quarter-over-quarter decrease of $1.9 million was primarily the result of lower personnel costs resulting from the Company's decision to discontinue commercial operations in September 2019.
    • Loss from continuing operations was $11.6 million and $26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $43.7 million and $71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was $27,000 and $0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to $6.2 million and $16.5 million for the quarter and six months ended June 30, 2019, respectively.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.



    Aclaris Therapeutics, Inc.

    Consolidated Statements of Operations

    (unaudited, in thousands, except share and per share data)

      Three Months Ended Six Months Ended
      June 30, June 30,
      2020 2019 2020 2019
    Revenues:            
    Contract research $1,853 $886 $3,042 $2,149
    Other revenue  193    411  
    Total revenues  2,046  886  3,453  2,149
                 
    Costs and expenses:            
    Cost of revenue (1)  1,389  994  2,658  2,201
    Research and development (1)  6,466  17,519  15,909  37,161
    General and administrative (1)  5,572  7,469  11,773  14,926
    Goodwill impairment    18,504    18,504
    Total costs and expenses  13,427  44,486  30,340  72,792
    Loss from operations  (11,381)  (43,600)  (26,887)  (70,643)
    Other expense, net  (189)  (85)  (11)  (315)
    Loss from continuing operations  (11,570)  (43,685)  (26,898)  (70,958)
    Loss from discontinued operations (1)  (27)  (6,191)  (285)  (16,483)
    Net loss $(11,597) $(49,876) $(27,183) $(87,441)
    Net loss per share, basic and diluted $(0.28) $(1.21) $(0.65) $(2.12)
    Weighted average common shares outstanding, basic and diluted  42,133,646  41,274,808  41,876,037  41,261,808
                 
    (1) Amounts include stock-based compensation expense as follows:            
                 
    Cost of revenue $252 $223 $512 $429
    Research and development  939  1,721  1,755  3,315
    General and administrative  2,118  2,654  4,495  5,126
    Loss from discontinued operations    216    806
    Total stock-based compensation expense $3,309 $4,814 $6,762 $9,676



    Aclaris Therapeutics, Inc.

    Selected Consolidated Balance Sheet Data

    (unaudited, in thousands)

      June 30, 2020 December 31, 2019
           
    Cash, cash equivalents, and marketable securities $68,115 $75,015
    Total assets  84,999  98,297
    Total current liabilities  17,745  22,432
    Total liabilities  35,633  28,385
    Total stockholders' equity  49,366  69,912



    Aclaris Contact



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  3. WAYNE, Pa., July 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical "soft" drug.

    "We are very pleased to have achieved another development milestone with the submission of this IND and look forward…

    WAYNE, Pa., July 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical "soft" drug.

    "We are very pleased to have achieved another development milestone with the submission of this IND and look forward to exploring the therapeutic potential of ATI-1777 in patients with moderate to severe AD," said Dr. David Gordon, Chief Medical Officer of Aclaris. "ATI-1777 is designed to be active in the skin but rapidly metabolized in the systemic circulation, with the goal of developing a medicine that is efficacious in the treatment of AD while limiting systemic exposure."

    If the IND is allowed, Aclaris plans to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at 4 weeks.

    About ATI-1777

    ATI-1777 is an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor.  "Soft" JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in the systemic circulation.  Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. If the IND is allowed, Aclaris plans to develop ATI-1777 as a potential treatment for moderate to severe atopic dermatitis.



    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-1777 as a potential treatment for patients with moderate to severe atopic dermatitis and the clinical development of ATI-1777. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact

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    • FDA Allows IND to Study ATI-450 in Hospitalized Patients with COVID-19
    • Aclaris Supports Investigator-Initiated Clinical Trial Sponsored by the University of Kansas Medical Center
    • ATI-450 Inhibits Multiple Key Inflammatory Cytokines

    WAYNE, Pa., June 17, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.  Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized…

    • FDA Allows IND to Study ATI-450 in Hospitalized Patients with COVID-19
    • Aclaris Supports Investigator-Initiated Clinical Trial Sponsored by the University of Kansas Medical Center
    • ATI-450 Inhibits Multiple Key Inflammatory Cytokines

    WAYNE, Pa., June 17, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.  Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The trial will be led by co-investigators Gregory Gan, M.D., Ph.D. and Deepika Polineni, M.D., M.P.H. The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy. The primary endpoint is the proportion of subjects who are free from respiratory failure by day 14.

    "CRS leads to the release of multiple inflammatory cytokines such as IL1β, IL6 and TNFα, which precedes acute respiratory distress syndrome, and is associated with significant morbidity and mortality in patients with COVID-19. ATI-450, a novel oral compound, has demonstrated that it targets the expression of inflammatory cytokines in a Phase 1 clinical trial in healthy volunteers. Therefore, we believe that ATI-450 may be an innovative approach to managing this disease," said Dr. Gan. As further noted by Dr. Polineni, "By mitigating CRS, important clinical outcomes such as oxygenation in patients with COVID-19 would be improved which could result in the reduced need for ventilation in patients in the intensive care setting." 

    ATI-450 has been observed to regulate pro-inflammatory cytokines associated with CRS.  Pharmacodynamic analysis from the first-in-human study using an ex vivo lipopolysaccharide (LPS) stimulation model demonstrated dose-dependent reduction of TNFα, IL1β, IL6 and IL8.   Further analysis using this LPS model showed marked inhibition of additional cytokines linked to CRS, including GM-CSF, IL2, IFNγ and MIP1α.  Furthermore, anti-inflammatory activity for ATI-450 was observed in a rat model of airway neutrophilia induced by inhaled LPS.  In addition, anti-viral1,2,3 and anti-fibrotic4,5 activity has been observed following blockade of the MK2 pathway in preclinical studies.

    "Many of the investigational drugs that are being evaluated to treat CRS target a single cytokine," said Dr. David Gordon, Chief Medical Officer of Aclaris. "We believe inhibiting multiple cytokines has the potential to achieve clinical benefits in patients with CRS, and this study will explore if ATI-450 is an effective approach in these patients. Thanks to KUMC, who are sponsoring this trial, we are able to evaluate ATI-450 as a potential treatment for COVID-19 at this critical time without impacting our ongoing clinical development programs. If successful, we hope to further explore the role that ATI-450 may have in helping patients with COVID-19 and addressing the healthcare challenges of the pandemic."

    Company to Host Conference Call

    Management will conduct a conference call at 8:30 AM ET today to discuss this trial and related matters.  The conference call will be webcast live over the Internet and can be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. A replay of the webcast will be archived on the Aclaris website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1366937 prior to the start of the call.

    About COVID-19

    Coronavirus disease 2019 (COVID-19) is a new pandemic disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some patients require hospitalization, mostly due to pneumonia, and can progress quickly to severe acute lung injury and acute respiratory distress syndrome (ARDS), which is associated with high mortality.6,7 A viral-induced cytokine storm or "hyperimmune response" is hypothesized to be a major pathogenic mechanism of ARDS.8,9,10

    About ATI-450

    ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development. This mechanism leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this mechanism include tumor necrosis factor α (TNFα) and interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris is developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.



    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-450 as a potential treatment for patients with COVID-19 and the clinical development of ATI-450. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact

    References

    1. McCaskill JL, Ressel S, Alber A, et al. Broad-Spectrum Inhibition of Respiratory Virus Infection by MicroRNA Mimics Targeting p38 MAPK Signaling. Mol Therapy: Nuc Acids. 2017;7:256-266.
    2. Luig C, Köther K, Dudek SE, et al. MAP kinase-activated protein kinases 2 and 3 are required for influenza A virus propagation and act via inhibition of PKR. FASEB J. 2010;24:4068-4077.
    3. Jimenez-Guardeño JM, Nieto-Torres JL, DeDiego ML, et al. The PDZ-Binding Motif of Severe Acute Respiratory Syndrome Coronavirus Envelope Protein Is a Determinant of Viral Pathogenesis. PLoS Pathog. 2014;10(8):1-20.
    4. Liang J, Liu N, Liu X, et al. Mitogen-activated Protein Kinase–activated Protein Kinase 2 Inhibition Attenuates Fibroblast Invasion and Severe Lung Fibrosis. Am J Respir Cell Mol Biol. 2019;60(1):41–48.
    5. Vittal R, Fisher A, Gu H, et al. Peptide-Mediated Inhibition of Mitogen-Activated Protein Kinase–Activated Protein Kinase–2 Ameliorates Bleomycin-Induced Pulmonary Fibrosis. Am J Respir Cell Mol Biol. 2013;49(1):47–57.
    6. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506.
    7. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395:1054-1062.
    8. Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020;395:1033-1034.
    9. Moore, JB, June CH. Cytokine release syndrome in severe COVID-19. Science. 2020;368(6490):473-474.
    10. Zhang C, Wu Z, Li JW, et al. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int. J. Antimicrob. Agents. 2020;55(5):1-6.

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  4. WAYNE, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced the publication of an abstract at the 2020 European Congress of Rheumatology (EULAR 2020 E-Congress) being held June 3-6, 2020.  The abstract details are as follows:

    Abstract No: SAT0143
    Title: A Phase 1 Study in Healthy Volunteers Exploring the Safety, Pharmacokinetics and Pharmacodynamics of ATI-450: A Novel Oral MK2 Inhibitor
    Authors: J. Schnyder, J. Monahan, W. Smith, H. Hope, D. Kelly, D. Burt, E. Huff, A. Kaul, A. Hildebrand, B. Burnette, N. Klug, M. Bangs, D. Gordon

    The abstract is published in the electronic Abstract…

    WAYNE, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced the publication of an abstract at the 2020 European Congress of Rheumatology (EULAR 2020 E-Congress) being held June 3-6, 2020.  The abstract details are as follows:

    Abstract No: SAT0143
    Title: A Phase 1 Study in Healthy Volunteers Exploring the Safety, Pharmacokinetics and Pharmacodynamics of ATI-450: A Novel Oral MK2 Inhibitor
    Authors: J. Schnyder, J. Monahan, W. Smith, H. Hope, D. Kelly, D. Burt, E. Huff, A. Kaul, A. Hildebrand, B. Burnette, N. Klug, M. Bangs, D. Gordon

    The abstract is published in the electronic Abstract Archive located here: "Abstract Archive."

    About ATI-450

    ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development. This mechanism leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this mechanism include tumor necrosis factor α (TNFα) and interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris is developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ATI-450. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact:
     

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