PhaseBio Pharmaceuticals, Inc. PHAS announced that the FDA cleared its investigational new drug (IND) application for PB1046, a novel subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, as a treatment for hospitalized COVID-19 patients who stands at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS). The IND clearance from the regulatory body came under the Coronavirus Treatment Acceleration Program (CTAP).
The company received the FDA authorization to begin the potentially pivotal clinical study – VANGARD, to evaluate PB1046 in the given patient population. The multi-center, randomized, double-blind VANGARD study will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients. The primary endpoint of the study will measure the days alive and free of respiratory failure.
The company plans to begin dosing patients by this June-end, with a target to report results late in the fourth quarter of 2020.
Per the press release, based on the FDA’s feedback, management believes that positive, clearly interpretable and clinically meaningful data from this above-mentioned study may enable the company to submit a Biologics License Application for PB1046 to address the given indication.
Shares of PhaseBio were up in pre-market trading on Thursday following the announcement of the news. However, the stock has declined 27.6% so far this year, versus the industry’s increase of 6.3%.
As the coronavirus pandemic aggravates, resulting in more and more deaths with each passing day, the race to develop treatments/vaccines to combat this contagious disease has intensified over the last couple of weeks.
We note that, Incyte INCY is working with the FDA to initiate a phase III study, RUXCOVID, to evaluate the efficacy and safety of Jakafi plus standard-of-care compared to standard-of-care therapy alone in patients with COVID-19-associated cytokine storm. The study will be sponsored by Incyte in the United States and Novartis NVS outside of the country.
Notably, a few other companies are also evaluating their marketed drugs in studies to address the deadly COVID-19. These include Roche’s RHHBY rheumatoid arthritis (“RA”) drug, Actemra, and Regeneron/Sanofi’s RA drug, Kevzara.
We remain optimistic about the developments in the pharma sector as several companies along with global authorities are laboring hard on rolling out a treatment as early as possible to neutralize this deadly virus.
PhaseBio is a Zacks Rank #3 (Hold) stock, currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report PHASEBIO PHARMA (PHAS) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research