Enrollment milestone advances the FDA Fast Track-designated program toward data review and analysis
TORONTO — Vasomune Therapeutics Inc. (“Vasomune”), a clinical-stage biopharmaceutical company developing medicines that target endotheliopathy and vascular leak, today announced the completion of patient enrollment in AV001-004 (NCT05123755), its randomized, double-blind, placebo-controlled Phase 2a clinical study evaluating Pegevongitide (AV-001) in patients hospitalized with pneumonia requiring supplemental oxygen.
Pegevongitide has received Fast Track designation from the U.S. Food and Drug Administration for the prevention and treatment of moderate-to-severe acute respiratory distress syndrome associated with respiratory infection. The designation is intended to facilitate the development and review of therapies for serious conditions with unmet medical needs.
With enrollment concluded, Vasomune and its clinical researchers will now focus on data quality assurance and quality control, clinical-data review and cleaning, site closeout activities and preparation for database lock.
“Completing enrollment is an important milestone for Vasomune and for the clinical development of Pegevongitide,” said Dr. Brian E. Jahns, Chief Executive Officer of Vasomune Therapeutics. “Pneumonia can destabilize the pulmonary vasculature, resulting in pulmonary edema and impaired oxygen exchange. Pegevongitide is designed to correct this vascular response by activating the Tie2 receptor, and reinforcing the endothelial barrier, regardless of whether the underlying infection is viral or bacterial.”
“We are grateful to the patients and families who participated in this study and to the investigators, clinical research teams and hospital staff who made its execution possible,” Mr. Shahid Ahmad, Vice-President of Operations, stated.
“Completion of enrollment represents another important step in the clinical evaluation of Pegevongitide,” said Dr. Ei Yamada, President and Chief Executive Officer of AnGes Inc. “We appreciate the commitment of the patients, investigators and clinical teams participating in AV001-004. AnGes remains committed to working with Vasomune to evaluate the potential of Pegevongitide as a new therapeutic approach for patients hospitalized with serious respiratory infections.”
AV001-004 is evaluating the safety, tolerability and exploratory efficacy of multiple intravenous administrations of Pegevongitide compared with placebo, each administered together with standard of care. The study enrolled patients hospitalized with presumed or documented viral or bacterial pneumonia requiring supplemental oxygen.
Pegevongitide is a first-in-class, fully synthetic PEGylated peptide designed to activate Tie2, a receptor that plays an important role in maintaining endothelial stability and vascular-barrier integrity. By reinforcing the vascular barrier, Pegevongitide is intended to reduce the leakage of fluid and proteins from blood vessels into surrounding tissues.
Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical Research Programs award number W81XWH-21-1-0834 for support of study AV001-004.