MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, 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).
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. 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-α, IFN-γ, 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.
“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,” said Jonathan Mow, Chief Executive Officer at PhaseBio. “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.”
The VANGARD trial (VIP ANalogue, in hospitalized COVID-19 patients at hiGh risk for rapid clinical deterioration and ARDS) is a multi-center, randomized, double-blind, parallel group clinical trial that will assess the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS. 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.
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.
“Physicians are in desperate need of new options to treat COVID-19 patients facing rapid deterioration of lung function and before progressing to a ventilator,” said John Lee, M.D., Ph.D., Chief Medical Officer at PhaseBio. “The impact of the pandemic on the global healthcare system has been overwhelming during the past few months and the importance of new treatment options that could help reduce this burden cannot be overstated. Based on what we’ve learned thus far about COVID-19 and acute respiratory distress syndrome, the prognosis for patients who ultimately require ventilator support is exceptionally poor. Early mitigation by PB1046 of the effects of inflammatory cytokines that can cause acute lung injury, is a promising strategy that could prevent patients from declining to the point where they require mechanical ventilation and help alleviate the strain on critical care infrastructure that we’re witnessing.”
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