FDA regulatory update on D-PLEX100 for abdominal colorectal surgical site infections
PolyPid provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs)
Following a recent type D meeting communication with the FDA on the SHIELD I Phase III data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission. PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs.
Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study, which to date has enrolled over 200 patients, could potentially serve as such a study. PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.
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