Benzinga | May 19, 2021 08:03AM EDT

PolyPid Reports Positive FDA Type B Meeting Feedback For D-PLEX100 Development Program

FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery.

* Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date

* Top-line Results Expected by Year-end

PETAH TIKVA, Israel, May 19, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced today it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX100.

The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid's receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.

"We appreciate the thoughtful feedback from the FDA regarding our clinical program, and we are thrilled with the acceptance of our proposed development plan for the potential approval of D-PLEX100, which also reduces overall anticipated costs for the program," said Amir Weisberg, PolyPid's CEO. "PolyPid is dedicated to tackling the issue of SSIs that accounts for 20 percent of all healthcare-acquired infections in the U.S., resulting in extended hospital stays and readmission, costing up to $10 billion in annual medical costs. We will use the responses provided to progress our SHIELD I trial which continues to enroll patients at the expected rate, with over 200 patients enrolled to date, and we anticipate the availability of top-line results by the end of 2021."

Launched in July 2020, SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 for the prevention of incisional SSIs post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.