PhaseBio Pharmaceuticals Inc. (NASDAQ: PHAS) announced early on Friday that it has initiated its midstage study evaluating a treatment for the novel coronavirus. The Phase 2 clinical trial will be specifically evaluating PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.
The company received U.S. Food and Drug Administration (FDA) clearance in May to initiate the VANGARD trial and, subject to the pace of enrollment and any further impacts from the COVID-19 pandemic itself, PhaseBio is looking to report results late in the fourth quarter of 2020.
Management noted that the inflammatory response to COVID-19 has been an exceptionally challenging aspect of managing infected patients, and those who require ventilator support have an especially poor prognosis.
PB1046 is a novel subcutaneously injected 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 and potent bronchodilatory and immunomodulatory effects in the respiratory system.
As the COVID-19 pandemic unfolded around the world, PhaseBio moved to develop a trial protocol and submit an IND application to the FDA to evaluate the potential of PB1046 to help COVID-19 patients at high risk of progressing to acute respiratory distress syndrome.
Also based on feedback from the FDA, PhaseBio believes that positive, clearly interpretable and clinically meaningful results from this trial may enable PhaseBio to submit a Biologics License Application.
PhaseBio stock traded up about 12% on Friday to $5.29, in a 52-week range of $2.60 to $10.40. The consensus price target is $15.67.
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