- Dr. Hess was selected as the recipient of an American Heart Association 2022 Paul Dudley White International Scholar Award, which is presented to the primary author of the highest ranked abstract submitted from each country to the conference.
- Dr. Hess, Associate Professor of Medicine at the University of Colorado and a faculty member at CPC Clinical Research, presented results from the ASPEN-COVID-19 Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.
AURORA, CO / ACCESSWIRE / May 17, 2022 / CPC Clinical Research, an academic research organization recognized for its expertise in comprehensive clinical trial design and management, announced that Dr. Connie Hess presented results from the ASPEN-COVID-19 clinical trial at the American Heart Association Vascular Discovery Scientific Sessions held May 12-14, 2022 in Seattle, Washington. Dr. Hess received the American Heart Association 2022 Paul Dudley White International Scholar Award, which is presented to the primary author of the highest ranked abstract submitted from each country to the conference. The clinical trial was conducted on behalf of ARCA biopharma, Inc. (NASDAQ:ABIO).
ASPEN‑COVID‑19 was a multicenter, international, randomized, Phase 2b clinical trial evaluating rNAPc2, a specific inhibitor of tissue factor with potent anticoagulant effects, as a potential treatment for patients hospitalized with COVID-19. This clinical trial used a 1:1:2 randomization between lower dose rNAPc2, higher dose rNAPc2, both head-to-head against highly effective standard of care heparin.
In her award-winning abstract, Dr. Hess presented primary trial results in her role as a member of the ASPEN Executive Committee. Key takeaways include:
- ASPEN was a high-quality trial with >95% of patients receiving all planned doses of randomized therapy and no lost to follow up.
- Patients received high quality background care including more than 95% receiving steroids, ~65% receiving remdesivir, ~20% also receiving other therapies.
- No trend for excess bleeding for the primary safety outcome or other adverse events was observed for lower or higher dose rNAPc2 compared with heparin.
- rNAPc2 reduced tissue factor activity by 20% (p=0.001) in the pooled rNAPc2 groups.
- There was no statistically significant difference in the primary efficacy endpoint of D-dimer at day 8 with rNAPc2 vs heparin, however, D-dimer was ~50% lower with rNAPc2 vs heparin overall and a ~2-fold lower D-dimer was observed with rNAPc2 vs. heparin among patients with mild disease (WHO severity scale).
- Few thrombotic events were observed overall with no statistically significant difference between the rNAPc2 and heparin groups.
Dr. Hess commented that "The extrinsic pathway of coagulation and tissue factor specifically are of great interest in thromboinflammatory conditions such as COVID 19. While currently approved anticoagulants like heparin act via the intrinsic coagulation pathway, rNAPc2 is a novel anticoagulant that acts through tissue factor inhibition in the extrinsic pathway and has demonstrated anti-inflammatory and anti-viral effects in pre-clinical studies."
The Executive Committee of the ASPEN trial is actively assessing the study results in the context of existing therapies and opportunities for a Phase 3 program in COVID 19 as well as other disease states where thromboinflammation plays a critical role.
About CPC Clinical Research
CPC Clinical Research is an academic research organization affiliated with the University of Colorado that is recognized for its expertise in innovative, pragmatic clinical trial design & management for both national and international clinical research. Drs. Connie Hess, Marc Bonaca (Executive Director of CPC), and Judith Hsia (CSO of CPC) are all CPC affiliated faculty members and are all on the ASPEN Executive Committee. All are faculty at the University of Colorado School of Medicine and Board-Certified Cardiologists with extensive experience in clinical trial research and help lead research studies at CPC. CPC has over 30 years of experience in managing all stages and types of clinical trials.
For more information, please visit https://cpcclinicalresearch.org/
David Poticha, General Counsel