PhaseBio Pharmaceuticals, Inc. PHAS announced that it has dosed the first patient in a potentially pivotal phase II study, VANGARD, on its pipeline candidate, PB1046. The study will be assessing the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).
The VANGARD study will enroll about 210 patients at about 20 sites nationwide. The primary endpoint in the study measures days alive and free of respiratory failure. Considering the pace of enrollment and any further impacts from the COVID-19 pandemic itself, the company expects to report initial data from the VANGARD study late in the fourth quarter of 2020.
Shares of the company have lost 10.1% year to date against the industry’s growth of 11.5%.
PB1046 is a novel, once-weekly, subcutaneously-injected vasoactive intestinal peptide (VIP) receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems. It has the potential to modulate several proinflammatory cytokines that are believed to be key drivers of the inflammatory response to COVID-19.
PhaseBio submitted an investigational new drug application (IND) to evaluate the potential of PB1046 to help COVID-19 patients at high risk of progressing to ARDS. The company received FDA clearance in May 2020 to initiate the VANGARD study.
The company is also developing PB1046 for the treatment of pulmonary arterial hypertension (PAH). It is in a phase II study for the same and results from the study are expected to be reported in 2021.
Zacks Rank & Other Stocks to Consider
PhaseBiocurrently carries a Zacks Rank #2 (Buy).
Some top-ranked stocks in the biotech sector are Emergent Biosolutions Inc. EBS, BioMarin Pharmaceutical Inc. BMRN and BioDelivery Sciences International Inc. BDSI, all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings per share estimates have increased from $3.14 to $4.23 for 2020 and from $3.35 to $4.31 for 2021 in the past 60 days.
BioMarin’s earnings per share estimates have increased from $1.51 to $1.56 for 2020 and from $2.46 to $2.79 for 2021 in the past 60 days.
BioDelivery’s earnings per share estimates have increased from 19 cents to 20 cents for 2020 and from 44 cents to 46 cents for 2021 in the past 60 days.
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