The FDA’s Newest Nod for a Coronavirus Treatment Trial

By Chris Lange Published May 28, 10:15AM EDT

The FDA’s Newest Nod for a Coronavirus Treatment Trial — © thenationalguard / Flickr

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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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.