PhaseBio Pharmaceuticals Inc. (NASDAQ:PHAS) Receives FDA Approval For PB1046 In Treatment Of COVID-19

PhaseBio Pharmaceuticals Inc. (NASDAQ:PHAS) stock surged over 80% on Wednesday following the announcement that the FDA had approved the company’s Investigational New Drug application under its COVID-19 Treatment Acceleration Program.

PhaseBio to evaluate efficacy and safety of PB1046 in ARDS patients

The company will assess the safety and efficacy of PB1046 through its VANGARD trial for high risk hospitalized coronavirus patients with ARDS and rapid clinical deterioration. The company plans to target up to 210 patients for enrolment in around 0 sites in the US. The main endpoint of the trial will be measuring days alive and also free from respiratory failure.

The company’s PB1046 is a once per week vasoactive intestinal peptide receptor against injected subcutaneously targeting VPAC receptors in the immune, pulmonary and cardiovascular systems. The vasoactive intestinal peptide is a neurohormone that has anti-fibrotic, anti-inflammatory, vasodilatory, inotropic, and lusitropic effects. Equally, VIP has been found to have potent respiratory system immunomodulatory and bronchodilatory effects.

Jonathan Mow, the CEO of PhaseBio, said that the company decided to pursue the evaluation of PB1046 as a possible COVID-19 treatment based on its mechanism of action and its documented profile that shows that a weekly dose reduces the need for IV infused for the VIP peptide. PhaseBio developed a study protocol and quickly submitted an IND to the FDA ahead of launching the trials quickly.

PhaseBio to report VANGARD results in Q4

PhaseBio’s VANGARD trial is a double-blind, randomized, 1parallel group, multicentre trial that will evaluate the safety and efficacy of PB1046. Patients in the clinical trial will receive PB1046 once per week, and dosing is expected to commence by the end of next month. The company is hoping to deliver the clinical trial results towards the end of Q4 2020.

The company is hoping then positive, clinically meaningful, and interpretable results from the VANGARD trial will enable the company to file for a Biologics License Application. So far, PB1046 has shown early inflammatory cytokines mitigation effects and could help patients from deteriorating to the point of needing ventilators.