ABIO ARCA biopharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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AB201
COVID-19
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Gencaro
Chronic Heart Failure
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Phase 3
Phase 3
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Phase 3 trial initiation on hold - dependent on obtaining additional financing.
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Latest News
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- Development addresses need for treatments for patients hospitalized with COVID-19 whether vaccines are available or not
- AB201 is the only novel compound being developed for COVID Associated Coagulopathy
- Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December
- Topline trial data anticipated Q2 2021
WESTMINSTER, Colo., Nov. 23, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19. The Company intends to initiate a Phase 2b clinical trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline trial data anticipated in the second quarter of 2021.
According to the FDA's Fast Track Guidance document, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
"Fast Track designation for the AB201 development program is an important acknowledgement of the critical need for treatments for hospitalized COVID-19 patients, whether effective vaccines are approved and available or not," said Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. "We believe AB201's combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19 and look forward to beginning the ASPEN-COVID-19 trial to evaluate AB201's potential efficacy in this patient population."
Fast Track drug development designation is included in the FDA Modernization Act of 1997 (FDAMA) as a formal process to enhance interactions with the FDA during drug development. A drug development program with Fast Track designation would be eligible for consideration for some or all of the following programs for expediting development and review: scheduled meetings to seek FDA input into development plans, priority review of the New Drug Application (NDA), the option of submitting portions of an NDA prior to submission of the complete application and potential accelerated approval. ARCA believes that AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation.
About AB201
AB201 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives AB201 a combination of anticoagulant, anti-inflammatory and antiviral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19 and other RNA virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential pharmacogenetic treatment for atrial fibrillation in patients with heart failure. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201, the expected features and characteristics of AB201, AB201's potential to treat COVID-19, CAC or any other RNA virus associated disease, whether AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation and future treatment options for patients with COVID-19. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
- Development addresses need for treatments for patients hospitalized with COVID-19 whether vaccines are available or not
-
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- Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID19 anticipated in fourth quarter
- Topline data from trial anticipated Q2 2021
WESTMINSTER, Colo., Nov. 02, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the third quarter of 2020 and provided a corporate update.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority. AB201's combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. We are working rapidly towards initiating the Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID-19."
Pipeline Update
AB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
- Advancing development of AB201 as a potential treatment for patients hospitalized with COVID-19
- U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19
- ARCA estimates initiating Phase 2b clinical testing of AB201 in fourth quarter of this year
Gencaro™ (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients. Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. Future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.
Third Quarter 2020 Summary Financial Results
Cash and cash equivalents were $51.1 million as of September 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022, including the projected costs for the AB201 Phase 2b clinical trial.
Research and development (R&D) expense for the three months ended September 30, 2020 was $1.1 million compared to $0.3 million for the corresponding period of 2019, an increase of $0.7 million. R&D expense for the nine months ended September 30, 2020 was $1.8 million compared to $1.4 million for the corresponding period of 2019, an increase of approximately $0.3 million.
Clinical expense increased approximately $0.3 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. Manufacturing process development costs increased approximately $0.2 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. The increase in costs were related to initial costs for the AB201 clinical trial, which the Company plans to initiate in the fourth quarter of 2020. The remaining increase is primarily a result of higher outside services and consulting costs.
General and administrative (G&A) expenses were $0.9 million for both the three months ended September 30, 2020 and 2019. G&A expenses were $2.9 million and $3.1 million for the nine months ended September 30, 2020 and 2019, respectively. The $0.2 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020.
Total operating expenses for the three months ended September 30, 2020 were $1.9 million compared to $1.2 million for the corresponding period in 2019. Total operating expenses for the nine months ended September 30, 2020 were $4.6 million compared to $4.5 million for the corresponding period in 2019.
Net loss for the three months ended September 30, 2020 was $2.0 million, or $0.33 per basic and diluted share, compared to $1.2 million, or $0.76 per basic and diluted share, for the corresponding period in 2019. Net loss for the nine months ended September 30, 2020 was $4.6 million, or $1.46 per basic and diluted share, compared to $4.3 million, or $3.46 per basic and diluted share, for the corresponding period in 2019.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, the potential for Gencaro to be the first genetically targeted AF prevention treatment and the ability of ARCA's financial resources to support its operations through 2022. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected](Tables follow)
ARCA BIOPHARMA, INC.BALANCE SHEET DATA
(in thousands)
(unaudited)September 30, 2020 December 31, 2019 Cash and cash equivalents $ 51,095 $ 8,363 Working capital $ 50,409 $ 7,554 Total assets $ 51,982 $ 8,536 Total stockholders' equity $ 50,455 $ 7,610 ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 (in thousands, except share and per share amounts) Costs and expenses: Research and development $ 1,051 $ 347 $ 1,788 $ 1,449 General and administrative 939 900 2,852 3,087 Total costs and expenses 1,990 1,247 4,640 4,536 Loss from operations (1,990 ) (1,247 ) (4,640 ) (4,536 ) Interest and other income 1 50 27 136 Interest expense (2 ) (1 ) (9 ) (7 ) Loss before income taxes (1,991 ) (1,198 ) (4,622 ) (4,407 ) Income tax benefit — 42 9 151 Net loss $ (1,991 ) $ (1,156 ) $ (4,613 ) $ (4,256 ) Net loss per share: Basic and diluted $ (0.33 ) $ (0.76 ) $ (1.46 ) $ (3.46 ) Weighted average shares outstanding: Basic and diluted 6,044,315 1,521,259 3,154,680 1,229,289 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
- Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID19 anticipated in fourth quarter
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- Initiation of Phase 2b clinical trial anticipated in Q4 2020
- Trial to enroll approximately 100 patients hospitalized with COVID-19
- Topline data anticipated Q2 2021
WESTMINSTER, Colo., Oct. 07, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results. The Company anticipates topline data from the trial in the second quarter of 2021.
The planned Phase 2b trial is anticipated to be a randomized comparison of two dose regimens of AB201 versus heparin prescribed per local standard of care. The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production. AB201 is a potent tissue factor inhibitor anticoagulant with anti-inflammatory and antiviral properties. The primary endpoint of the trial will be change in D-dimer level from baseline to Day 8. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes. If Phase 2b indicates a favorable effect on D-dimer levels, following FDA review of the data and identification of the proposed Phase 3 AB201 dose, the Company anticipates that clinical investigative sites will begin enrolling in the planned Phase 3 clinical trial. The primary endpoint of Phase 3 will be clinical recovery as measured by the Adaptive COVID-19 Treatment Trial (ACTT-1) ordinal scale, with secondary endpoints that include D-dimer levels and the number of thrombotic events. Phase 3 will be event driven, with an estimated requirement of 450 patients. The Phase 2b and Phase 3 trials are described in a common protocol and use identical entry criteria and the same heparin regimen control.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator, commented, "The ASPEN-COVID-19 trial will use the coagulopathy biomarker D-dimer to identify an optimal dose from AB201 regimens that are both within the therapeutic range as determined from Phase 2 trials investigating cardiovascular thrombosis prophylaxis. If successful, we anticipate using this dose in a planned Phase 3 trial to evaluate potential improvement in clinical outcomes. We believe that the combination of anticoagulant, anti-inflammatory and antiviral effects of AB201 may favorably impact clinical recovery of patients hospitalized with COVID-19."
The trial is being managed in collaboration with the Colorado Prevention Center (CPC), the University of Colorado's Academic Research Organization with extensive experience in managing vascular and anticoagulation clinical trials.
Marc Bonaca, MD, Executive Director of CPC, commented: "The ASPEN-COVID-19 trial will enable us to step beyond the question of intensity of anticoagulation and ask the question of whether specifically targeting tissue factor, a key step in the extrinsic pathway of anticoagulation and a key part of viral pathogenesis, improves outcomes in COVID-19. Dosing and safety are critical, and the Phase 2 trial will enable selection of a dose for safety, coagulopathy, and anti-viral parameters for use in a planned Phase 3 clinical trial. This selected dose will be deployed in the proposed Phase 3 pivotal outcomes study with the hope of translation to the clinical setting. We believe this therapy holds promise to improve outcomes in the current pandemic and given the positive findings in an Ebola animal model, has the potential for broader application in other severe viral infections characterized by coagulopathy."
About AB201
AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated diseases, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives AB201 a combination of anti-coagulant, immuno-modulatory and anti-viral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19 and other RNA virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential pharmacogenetic treatment for atrial fibrillation in patients with heart failure. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19 or any other RNA virus associated disease, future treatment options for patients with COVID-19, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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WESTMINSTER, Colo., Oct. 05, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the promotion of Debra Marshall, MD, FACC to Chief Medical Officer, and Sharon Perry, RAC, to Vice President, Regulatory Affairs and Quality.
Dr. Marshall joined ARCA in 2016 as Senior Vice President, Medical Affairs. She has spent more than 20 years dedicated to cardiovascular drug development. Prior to joining ARCA, she served as an Executive Medical Director in the Cardiovascular Therapeutic Area at Amgen, Senior Medical Director in Cardio-Metabolism at Genentech, Global Senior Medical Director for the CV/Acute Care team at Lilly and Associate Medical Director for CV Medical Affairs at Novartis Pharmaceutical Corporation. Dr. Marshall has been involved development and approval of medicines for Heart Failure, Hypertension, Acute Coronary Syndromes and Dyslipidemias. Dr. Marshall holds a B.S. in Chemistry and an M.D. from the University of California, Los Angeles. She completed an internship in Internal Medicine at the University of Pennsylvania, Philadelphia and a Cardiology fellowship at the Oregon Health Sciences University in Portland, Oregon. Dr. Marshall has been an NIH and AHA grant recipient and has authored numerous scientific and clinical publications. She earned board certifications in Internal Medicine, Cardiovascular Diseases, Interventional Cardiology and Nuclear Cardiology.
Ms. Perry joined ARCA in 2008 as Senior Manager, Quality. She has more than 30 years of pharmaceutical industry experience as a Regulatory and Quality professional. Prior to joining ARCA, she was Quality Assurance Manager at Colorado Histoprep, Quality Assurance Specialist at Gilead Sciences, Chemist at Paragon Analytics, Manager of Quality for PR Pharmaceuticals and Quality Assurance Coordinator at Pfizer. Ms. Perry's expertise includes Quality Department and Quality Management Systems development and implementation, global Good Clinical, Laboratory and Manufacturing Practices (GXP), FDA pre-approval and Good Manufacturing Practices (GMP)/Good Clinical Practice (GCP) inspections, New Drug Applications (NDA), Investigational New Drug (IND) applications and Clinical Trial Applications, and Fast Track Designation and Orphan Drug Designation applications.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted atrial fibrillation (AF) prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19 or any other RNA virus associated disease, future treatment options for patients with COVID-19, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected] -
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WESTMINSTER, Colo., Sept. 21, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "This IND submission is a key milestone in the clinical development of AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19, as well as other RNA virus associated diseases."
About AB201 (rNAPc2)
AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives AB210 a combination of anti-coagulant, immuno-modulation and anti-viral properties, and therefore the potential to be effective in addressing the pathologies caused by viral infections from multiple aspects. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19 and other RNA virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted atrial fibrillation (AF) prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19 or any other RNA virus associated disease, future treatment options for patients with COVID-19, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740.