ASPEN-COVID-19 Data and Security Monitoring Committee
- End of registrations expected by the end of 2021
- Key figures expected in the first quarter of 2022
WESTMINSTER, Colo., October 28, 2021 (GLOBE NEWSWIRE) – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to the development of genetically targeted therapies for cardiovascular disease, released today an update on the ASPEN-COVID-19 Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with severe COVID-19. The Company announced that the Data and Safety Oversight Committee (DSMC) has completed a pre-defined interim analysis and, based on the DSMC’s review of approximately 75% of the final efficacy and safety data. planned, recommended the completion of the clinical trial without any changes. in the design of the test. The rNAPc2 development program has received Fast Track designation from the United States Food and Drug Administration (FDA). The company now plans to complete the target recruitment of 160 patients by the end of 2021 and to report baseline data in the first quarter of 2022.
Dr Michael Bristow, President and CEO of ARCA, said: “Performing the final interim analysis without any recommended changes in the design of the Phase 2b clinical trial is an important step in a clinical trial and in the development of rNAPc2 for the prevention of COVID-Coagulopathy 19-associated. We are focused on completing the clinical trial, which we believe will complete recruitment by the end of the year. We look forward to sharing key trial results in the first quarter of next year and reviewing the results with the FDA. “
ASPEN-COVID-19 is an international, multi-center, randomized, phase 2b clinical trial evaluating two dosing regimens of rNAPc2 versus heparin in approximately 160 SARS-CoV-2 positive hospital patients who also have elevated D-dimer levels. . The primary endpoint of the trial is the change in D-dimer level between baseline and day 8 compared to standard heparin. D-dimer is a commonly used biomarker to assess coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is associated with adverse clinical outcomes. Heparin is a blood thinner commonly given to any patient hospitalized in the United States for COVID-19. The other objectives of phase 2b are to assess safety, determine the optimal rNAPc2 regimen for a potential phase 3 clinical trial, and assess several additional clinical endpoints, as detailed in the ASPEN-COVID listing. -19 on clinicaltrials.gov.
The United States Food and Drug Administration (FDA) has designated the rNAPc2 investigation as a potential treatment for COVID-19 as an accelerated development program. ARCA believes rNAPc2 is the only new anticoagulant class chemical entity in development for COVID-19.
About rNAPc2 (AB201)
rNAPc2 is a small recombinant protein in development as a potential treatment for COVID-19 and potentially other viral diseases. rNAPc2 is a potent selective tissue factor (TF) inhibitor, which has been identified to play a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPc2 a combination of potential anticoagulant, anti-inflammatory and antiviral properties, and therefore may be effective in combating the impact of viral infections originating from multiple pathways. rNAPc2 has already undergone phase 1 and phase 2 testing in more than 700 patients, including in clinical studies for the prevention of venous and arterial thrombosis, where it has been shown to be effective in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by the coronavirus may have a lot in common with other serious infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, causing serious complications. Recent mechanistic findings, as well as previous data from studies in non-human primates (PNH) given lethal doses of Ebola or Marburg filovirus demonstrating reductions in morbidity and mortality, decreases in inflammatory biomarkers, and reduced viral load, indicate that rNAPc2 may have a strong antiviral effect. and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that, collectively, these observations provide a strong rationale for investigating rNAPc2 as a treatment for COVID-19 and other illnesses associated with the virus.
About ARCA biopharmaceutical
ARCA biopharma is dedicated to the development of genetically targeted therapies for cardiovascular disease through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The US FDA has granted Fast Track designation to the rNAPc2 development program, which is currently in phase 2 clinical trials. ARCA is also developing GencaroMT (bucindolol hydrochloride), an experimental and pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in patients with heart failure. ARCA has identified common genetic variations that it believes predict patients’ individual response to Gencaro, giving it the potential to be the first genetically targeted prevention treatment for AF. The US FDA has granted Fast Track designation to the Gencaro development program and a Special Protocol Assessment Agreement (SPA). For more information, please visit www.arcabio.com or follow the Company on LinkedIn.
Safe Harbor Declaration
This press release contains “forward-looking statements” for the purposes of the safe harbor under the Private Securities Litigation Reform Act of 1995. These statements include, without limitation, statements regarding potential future development plans for rNAPc2, the characteristics and characteristics of rNAPc2, the expected development schedule for rNAPc2, the potential of rNAPc2 to treat COVID-19, or any other disease associated with the RNA virus, if rNAPc2 is the only new anticoagulant class chemical entity in development for COVID-19 and the Potential Future Treatment Options and Needs of COVID-19 Patients. These statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in forward-looking statements due to many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to achieve its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, if at all, to continue the development of rNAPc2 or otherwise to continue its activities in the future; the results of previous clinical trials may not be confirmed in future trials; the protection and commercial exclusivity provided by ARCA’s intellectual property; risks associated with drug discovery and the regulatory approval process; and the impact of competing products and technological change. These and other factors are identified and described in more detail in documents filed by ARCA with the Securities and Exchange Commission, including, without limitation, ARCA’s annual report on Form 10-K. for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intention or obligation to update these forward-looking statements.
Investor and media contact:
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740