ARCA biopharma, Inc. (ABIO) experiences an incline of 9.92% in the aftermarket because the company updated about the ASPEN-COVID-19 Phase 2b clinical study. However, the last trading session closed at $2.62 with an incline of 0.77%.
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ASPEN-COVID-19 Phase 2b clinical trial
On 28th October 2021, ABIO provided an update on the ASPEN-COVID-19 Phase 2b clinical trial. The Data and Safety Monitoring Committee (DSMC) performed a pre-specified interim analysis and advised that the clinical trial be completed with no adjustments to the trial design. This is based on the DSMC’s examination of roughly 75% of the expected final effectiveness and safety data. Moreover, the US Food and Drug Administration has given the rNAPc2 development program Fast Track status (FDA). The company now expects to finish the 160-patient goal enrollment by the end of 2021 and disclose topline data in the first quarter of 2022.
Furthermore, the completion of the last intermediate analysis with no proposed changes to the Phase 2b clinical trial design is a critical step in the development of rNAPc2 for the prevention of COVID-19-associated coagulopathy. ABIO is concentrating on completing the clinical study. Last but not least, the company also plans to release the top-line trial results and consult with the FDA about the findings.
Enrollment of First International Patient in Phase 2b Clinical Trial
ABIO announced the enrollment of the first patient in the Phase 2b clinical trial on 16th September 2021. The patient has been enrolled in Brazil. ARCA also intends to enroll patients from Argentina and is presently enrolling patients in numerous locations around the United States. As of now, over 75% of the participants in the worldwide Phase 2b study have signed up. ASPEN-COVID-19 is a Phase 2b randomized, multi-center, multinational clinical study comparing two dosing regimens of rNAPc2 vs heparin.
Moreover, the change in D-dimer level from baseline to Day 8 in comparison to standard of care heparin is the trial’s primary endpoint. Another goal of Phase 2b is to examine the safety and find the best rNAPc2 dosage regimen for Phase 3. D-dimer is a coagulation activation biomarker that is high in 40 percent to 75 percent of hospitalized COVID-19 patients and is linked to poor clinical outcomes. Lastly, the exploration of rNAPc2 as a possible COVID-19 therapy has been classified as a Fast Track development program by the US Food and Drug Administration (FDA).
Submission of PCT Patent Application
ABIO stated on 9th August 2021 that it has filed a PCT patent application for the use of the Company’s developing medication rNAPc2. This is done to treat patients hospitalized with COVID-19, which builds on previously filed provisional patent applications. The patent is based on groundbreaking research findings from Univ.-Prof. Dr. Wolfram Ruf’s laboratory at the University Medical Center Mainz’s Center for Thrombosis and Hemostasis (CTH).
Moreover, if rNAPc2 is further developed and licensed for this indication, the Company estimates that if this patent is granted, it will give effective market exclusivity for the treatment of patients with SARS-CoV-2 infection and associated coagulopathy in certain countries until roughly 2040. As necessary, the Company intends to seek patent protection in other countries.