-=PhaseBio Pharmaceuticals (PHAS) receives FDA clearance to launch clinical trial evaluating PB1046 as a treatment for hospitalized COVID-19 patients

PhaseBio Pharmaceuticals receives FDA clearance to launch clinical trial evaluating PB1046 as a treatment for hospitalized COVID-19 patients

PhaseBio Pharmaceuticals today announced FDA authorization to proceed with VANGARD, 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).

Having received FDA clearance to initiate the VANGARD trial, PhaseBio expects to begin dosing patients by the end of June.

Subject to the pace of enrollment and any further impacts from the COVID-19 pandemic, PhaseBio is targeting to report trial results late in the fourth quarter of 2020.

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.

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 or its receptors, VPAC1 and VPAC2. Importantly, VIP has also been observed to have potent bronchodilatory and immunomodulatory effects in the respiratory system. Specifically, VIP has been shown to regulate proinflammatory cytokines including TNF-a, IFN-y, IL-12, IL-17A, and IL-6. In animal models, treatment with VIP peptide prevented acute lung injury and inhibited cytokine-mediated inflammatory responses that are characteristic of ARDS.