Type: Once-weekly, subcutaneously-injected vasoactive intestinal peptide (VIP) receptor agonist designed to target VPAC receptors in the cardiovascular, pulmonary, and immune systems. The VIP analogue is a recombinant fusion protein composed of VIP and PhaseBio’s proprietary elastin-like polypeptide (ELP) biopolymer.
VIP is a neurohormone known to have anti-inflammatory, antifibrotic and potent bronchodilatory and immunomodulatory effects in the respiratory system—and has been shown to regulate proinflammatory cytokines that include TNF-α, IFN-γ, IL-12, IL-17A and IL-6.
Status: PhaseBio said July 16 the first patient was dosed in its potentially pivotal Phase II VANGUARD trial (NCT04433546), designed to assess PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).
VANGARD (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 is intended to evaluate the efficacy and safety of PB1046. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 U.S. centers, PhaseBio said.The primary endpoint is the number of days participants are alive and free of respiratory failure through day 28.
PhaseBio won FDA authorization to proceed with VANGUARD in May.
The company plans to report trial results late in the fourth quarter. “Positive, clearly interpretable and clinically meaningful” results may enable the company to submit a Biologics License Application, PhaseBio added. PB1046 is also in Phase II development for the treatment of pulmonary arterial hypertension (PAH).
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: