Based on feedback from the FDA, the company determined that the 70 patients targeted for enrollment in each of the VANGARD trial’s treatment arms would be insufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, would be required.
After an interim analysis of the first 25 patients, PhaseBio did not observe any data trends in the 40 mg or 100 mg pemziviptadil-treated arms suggesting a reasonable probability of achieving the primary efficacy endpoint. Pemziviptadil was generally well tolerated, and no safety concerns were identified.
This is what happens when you try and make VIP better than nature. VIP in it's Natural 28 amino acid chain is the most efficient at doing what it is supposed to do. And last no longer than it needs to.
That my friends is evolution at work
I was hoping PhasBio drug could help but it seems it hasn't...but we have more data for VIP and derivatives being safe
The reason they pulled the study is not necessarily because their version of VIP didn't work for Covid (although, I haven't seen the press releases from them regarding successes like we've seen with Aviptadil)...it's because they had a poorly designed study. Sounds like they don't have the rock stars working for them like Relief/NeuroRX have.
"Based on feedback from the FDA, the company determined that the 70 patients targeted for enrollment in each of the VANGARD trial’s treatment arms would be insufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, would be required."
The article goes on to state that they will simply refocus their drug
"The ongoing Phase 2b trial of pemziviptadil in patients with pulmonary arterial hypertension (PAH) is expected to resume enrollment after a pause related to COVID-19 pandemic and re-prioritization of drug supply to the VANGARD trial. To date, around 1/3rd of the patients targeted for enrollment have completed the initial 16 week protocol. Results are expected in 2H 2021."