PolyPid Announces 500th Patient Enrolled in SHIELD I Phase 3 Clinical Trial of D-PLEX₁₀₀ in Abdominal Surgery
Company Continues to Expect that the Last Patient Will be Enrolled in the Second Quarter of 2022, Followed by Top-Line Results Two Months Thereafter
| Source: PolyPid Ltd.
PETAH TIKVA, Israel, Nov. 18, 2021 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics to improve surgical outcomes, announced today that the 500th patient has been enrolled into its ongoing Phase 3 SHIELD I study. SHIELD I is a pivotal study evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The Company continues to expect that the completion of enrollment in SHIELD I will occur during the second quarter of 2022, with top-line results anticipated two months thereafter.
SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) 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 in post-abdominal surgery. The trial will continue with patient enrollment, toward approximately 900 patients, in about 60 centers across the United States, Europe and Israel. A blinded review of the overall event rates will commence once the 500th patient completes the 30-day follow-up and is evaluated for the primary endpoint.
Provided the study results are adequate, the U.S. Food and Drug Administration (FDA) has previously agreed that a single pivotal Phase 3 study is sufficient for potential approval of D-PLEX100 for the prevention of SSIs in colorectal surgery.
“Remaining as one of the most frequent complications following abdominal surgery, SSIs often result in significant morbidity, and continue to create substantial healthcare costs,” stated Amir Weisberg, PolyPid’s Chief Executive Officer. “Consistent with our mission of improving surgical outcomes, we are thrilled by the ongoing pace of enrollment in the SHIELD I trial and expect that this study will generate important insights surrounding both the medical and health economic benefits of D-PLEX100.”
PolyPid’s lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
PolyPid Ltd. (Nasdaq: PYPD) is a phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).