Vasomune Therapeutics has announced that its novel investigational medicine, AV-001, has received US Food and Drug Administration (FDA) fast track designation for the treatment of moderate to severe pathogen-induced acute respiratory distress syndrome (ARDS).

As per the 28 May press release, fast track designation was granted based on the high unmet medical need in ARDS. The status allows for earlier interactions with the FDA in the pursuit of accelerated approval and also the possibility to undergo rolling reviews.

ARDS is a life-threatening lung injury that enables fluid to leak into the lungs, causing breathing difficulties and low blood oxygen. According to the press announcement, ARDS is characterised by high mortality rates that can reach up to 46% in patients with severe cases of the disease. 

AV-001, a polyethylene glycol (PEG)-clustered Tie2 agonist peptide that was first discovered at Sunnybrook Research Institute at Sunnybrook Hospital, is designed to improve healing in patients by providing a molecular shortcut in blood vessel growth associated with wound closure.

The drug candidate is actively being evaluated in a Phase IIa study (NCT05123755) for the prevention and treatment of hospitalised patients with pneumonia-associated ARDS. The primary endpoint of the study is the safety and tolerability of multiple intravenously administered doses of AV-001 compared to placebo.

The Phase I study (NCT04737486) demonstrated a good safety and tolerability profile with strong on-target activity. There were no drug-related discontinuations or deaths, no suspected unexpected severe adverse reactions (SUSARs), and no adverse events of special interest (AESIs), as reported at the 2024 Respiratory Innovation Summit (RIS).

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“Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said president and Chief Operating Officer of Vasomune, Dr. Brian Jahns.

The Toronto, Ontario-based biotech is not the only player in the ARDS space. In October 2023, BioAegis Therapeutics was awarded a $20m contract from the US Biomedical Advanced Research and Development Authority (BARDA) for the development of plasma gelsolin for the treatment of ARDS. Also making headway is Healios, which in April 2023, reported positive topline results from the open-label ONE-BRIDGE clinical study of somatic stem cell regenerative therapy MultiStem (HLCM051/invimestrocel) in ARDS patients across Japan.