ARCA biopharma Announces Completion of Enrollment in Phase 2b ASPEN-COVID-19 Clinical Trial Evaluating rNAPc2 as a Potential Treatment for Patients Hospitalized With COVID-19

ARCA biopharma, Inc. recently announced that enrollment has been completed in ASPEN–COVID–19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.   160 patients were enrolled at clinical investigative sites in the US, Argentina, and Brazil. The company anticipates reporting topline data from the clinical trial in the first quarter of 2022.

ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is associated with adverse clinical outcomes.   Heparin is an anticoagulant commonly given to any patient hospitalized in the US for COVID-19. Other objectives of Phase 2b are to assess safety, determine the optimal dose regimen of rNAPc2 for a potential Phase 3 clinical trial and evaluate multiple additional clinical endpoints. Detailed information about the ASPEN-COVID-19 clinical trial is available at its listing on clinicaltrials.gov.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, said “Completing enrollment in ASPEN-COVID-19 is a significant milestone for the development of rNAPc2 as a potential treatment option for patients hospitalized with COVID-19 who have biomarker evidence of coagulopathy. We are grateful to the patients, their families, investigators and clinical research sites that are participating in the trial. We look forward to sharing the top-line trial results in the first quarter of next year and reviewing the findings with the FDA.”

The US FDA has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.

rNAPc2 is a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases. rNAPc2 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 rNAPc2 a combination of anti-coagulant, anti-inflammatory and potential anti-viral properties, and therefore may be effective in addressing the impact of viral infections from multiple pathways. rNAPc2 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 rNAPc2 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 rNAPc2 as a treatment for COVID-19 and other virus associated diseases.

ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases 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, currently in Phase 2 clinical testing. ARCA is also developing Gencaro (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 US FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, visit www.arcabio.com.