Vasomune Therapeutics has completed enrolment in its AV001-004 Phase IIa trial assessing Pegevongitide (AV-001) in patients hospitalised with pneumonia requiring supplemental oxygen.
The randomised, double-blind, placebo-controlled study will examine the safety, tolerability, and exploratory efficacy of intravenously administered Pegevongitide versus placebo, both alongside standard of care.
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It enrolled patients with presumed or confirmed viral or bacterial pneumonia who needed additional oxygen support.
Pegevongitide has been granted fast track designation by the US Food and Drug Administration (FDA) to prevent and treat moderate-to-severe acute respiratory distress syndrome (ARDS) related to respiratory infection.
Now that enrolment is complete, Vasomune Therapeutics will focus on data quality assurance, review and cleaning, site closeout, and preparations for locking the study database.
Vasomune Therapeutics CEO Dr Brian Jahns said: “Completing enrolment is an important milestone for Vasomune and for the clinical development of Pegevongitide. Pneumonia can destabilise the pulmonary vasculature, resulting in pulmonary oedema 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.”
Pegevongitide is described as a first-in-class, fully synthetic PEGylated peptide targeting activation of the Tie2 receptor, which plays a key role in stabilising the endothelium and maintaining the integrity of the vascular barrier.
Vasomune Therapeutics states that by supporting the vascular barrier, Pegevongitide can reduce fluid and protein leakage from blood vessels into the nearby tissues.
The therapy is being developed under an agreement with AnGes, a Japanese biopharmaceutical firm specialising in gene-based medicines.
Funding for the AV001-004 study was provided by the US Department of Defense under award number W81XWH-21-1-0834.
Vasomune Therapeutics is headquartered in Toronto, Canada, with US offices in Raleigh, North Carolina.
