PhaseBio Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to begin a VANGARD pivotal clinical to assess PB1046 as a treatment for hospitalised Covid-19 patients.
The multi-centre, randomised, double-blind and parallel-group clinical study will evaluate the efficacy and safety of once-weekly subcutaneous injections of PB1046 in hospitalised Covid-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).
The PB1046 is a novel, once-weekly and subcutaneously-injected vasoactive intestinal peptide (VIP) receptor agonist designed to target VPAC receptors in the cardiovascular, pulmonary and immune systems.
PhaseBio chief medical officer Dr John Lee said: “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.”
PhaseBio is planning to recruit up to 210 patients at around 20 sites in the US. The company intends to commence dosing patients by the end of June.
According to the company, the primary endpoint will measure days alive and free of respiratory failure.
PhaseBio aims to reveal trial results late in the fourth quarter of this year based on the pace of patient recruitment and challenges resulting from the Covid-19 pandemic.
Upon receiving feedback from the FDA, the company plans to use the data from the trial to submit a biologics licence application.
In addition, the PB1046 is currently under phase 2 development to treat pulmonary arterial hypertension (PAH).
PhaseBio already secured orphan drug designation from the FDA for PB1046 to treat PAH and pulmonary arterial hypertension.
PhaseBio CEO Jonathan Mow said: “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.”
Recently, Octapharma USA has secured approval from the FDA for its investigational new drug (IND) application to begin a phase three clinical trial to assess the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in Covid-19 patients with severe disease progression.