Regulatory2026-11-28

D-PLEX100 - (SHIELD II)

PolyPid Ltd.PYPD
Indication
Surgical Site Infection
Stage
phase5
Event
Regulatory Decision
Details

October 21, 2026: PolyPid Ltd. (NASDAQ: PYPD) said it will present an oral late-breaking abstract at IDWeek 2026 on October 22, 2026, on D-PLEX100 for prevention of surgical-site infections (SSIs). The presentation reports an exploratory pooled microbiology analysis from one Phase 2 trial and the Phase 3 SHIELD I and SHIELD II trials (N=2,185).

Among 134 patients with culture-positive SSIs (D-PLEX100 n=51; standard of care n=83), heavy bacterial growth was less frequent with D-PLEX100 plus standard of care than with standard of care alone (16% vs. 27%; p=0.034), and breakthrough SSIs occurred later (median 10.0 vs. 6.5 days; p<0.001). The proportions of multidrug-resistant organisms were similar between groups, and the difference in doxycycline resistance was not statistically significant. No statistically significant differences were seen in non-wound infections, systemic antibiotic use, or inflammation across the pooled population.

The company also states D-PLEX100 previously showed a 60% relative risk reduction in SSI incidence in the Phase 3 SHIELD II trial (p=0.0013) in abdominal colorectal surgery with large incisions, and that its NDA remains under FDA review. The IDWeek presentation is scheduled for October 22, 2026, 10:30-11:45 a.m. ET in Washington, D.C.