Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA.
Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity.
The D-Plex antibiotic drug reservoir is designed to prevent post-cardiac surgery sternal infection. Following surgery, the reservoir constantly releases entrapped antibiotic over the course of several weeks.
“The receipt of QIDP designation from the FDA represents an important milestone that expedites and extends the commercial path for D-Plex in the U.S.,” CEO Amir Weisberg said in prepared remarks. “We view this QIDP designation as validation of the significant potential of D-Plex in preventing and treating surgical site infections. We look forward to the availability of additional data by year-end 2017 from our ongoing Phase Ib/II study in Israel of D-Plex in post-cardiac surgery sternal infection.”
Data from an ongoing Phase Ib/II study of D-Plex showed no sternal infection at a 3-month follow-up point in treated patients. PolyPid reported that the reservoir is safe, as there were no adverse events related to the product.
The company plans to seek regulatory nods in the U.S. and Europe in the coming year to conduct a Phase III trial of D-Plex. PolyPid finished a pre-IND meeting with the FDA and the federal watchdog said that D-Plex can move directly into a Phase III trial in the U.S., according to the company.