The FDA’s Newest Nod for a Coronavirus Treatment Trial

PhaseBio Pharmaceuticals Inc. (NASDAQ: PHAS) shares jumped early on Thursday after the company announced that it received an authorization from the U.S. Food and Drug Administration (FDA) regarding its COVID-19 treatment.

Specifically, the company announced FDA authorization to proceed with Vanguard, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).

Note that PB1046 is a novel vasoactive intestinal peptide (VIP) receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems. VIP is a neurohormone known to have anti-inflammatory, antifibrotic, inotropic, lusitropic and vasodilatory effects, and several cardiopulmonary disorders are associated with alterations in levels of VIP.

For the trial, approximately 210 patients will be targeted to be enrolled at approximately 20 sites nationwide. The primary endpoint will measure days alive and free of respiratory failure. PhaseBio expects to begin dosing patients by the end of June and results are expected in the fourth quarter of 2020.

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Jonathan Mow, CEO of PhaseBio, commented:

Based on the mechanism of action, the well-documented clinical profile of PB1046, a once-weekly-dosing regimen that eliminates the need for continuous IV infusions required to administer VIP peptide, and evidence of activity of VIP peptide in ARDS, we decided to pursue a rigorous, double-blind randomized trial to evaluate PB1046 as a treatment for COVID-19 patients at high risk of progressing to acute respiratory distress syndrome. PhaseBio moved very rapidly to develop a study protocol and submit an investigational new drug application (IND) to the FDA. I would like to thank the team at PhaseBio, our network of advisors and investigators and the FDA for the collaborative effort to launch this trial in such an expedited manner.

PhaseBio stock was last seen up 39% at $6.11, in a 52-week range of $2.60 to $14.08. The consensus price target is $15.25.

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