Crushed by PhIII antibiotic flop, PolyPid says it got FDA support for a comeback — by focusing on subgroup
When PolyPid revealed its lead program had flunked the main goal of the first Phase III trial, it underscored positive results from a subgroup analysis. The Israeli biotech, which already had another Phase III underway, said it would talk to the FDA before deciding what to do with the second trial.
Almost five months later, the company says the FDA is keeping the doors open for an approval.
PolyPid’s lead candidate, D-PLEX100, is a formulation of the antibiotic doxycycline. On the molecular level, it comprises alternating layers of polymers and lipids that entrap the drug, thereby allowing for a prolonged and sustained release; practically, it’s a paste that can be applied directly during surgery to surgical sites to prevent infections.
In SHIELD I, the failed trial, PolyPid looked at the combination of incisional surgical site infections and mortality. It found that while D-PLEX100 decreased both infections and deaths compared to standard of care, the difference wasn’t statistically significant (23% reduction, p=0.1520).
But zooming into a pre-specified subgroup — an analysis that PolyPid said the FDA requested — investigators found that patients with large incisions (i.e. those larger than 20 cm) who received PolyPid’s treatment did see a 54% reduction in infections and deaths (p=0.0032).
According to PolyPid, the agency said in a recent meeting that the subgroup data “may provide supportive evidence” for use in this patient population — and “recommended that the Company conduct an additional study to support a potential NDA submission.”
Regulators also confirmed that SHIELD II, a study for which PolyPid has already enrolled more than 200 patients, could potentially be that additional study, the company said.
PolyPid is working “expeditiously” to revise and finalize the design of that trial, with plans to resume patient recruitment over the next few months. Execs are also in talks with regulators in Europe.
How expeditiously the company can go will be critical. News of the SHIELD I disappointment had decimated PolyPid’s shares on Nasdaq, pushing it off a cliff from more than $6 to the dollar-range. The company laid off 20% of its employees in an effort to reduce cost and extend its cash runway into the third quarter of 2023.
The stock is trading at $1.05 Tuesday morning.