PolyPid announces publication in IJS on Phase 3 SHIELD I trial of D-PLEX100

PolyPid (PYPD) announced a publication in the International Journal of Surgery, IJS, titled, “Effect of Local Prolonged-Release Incisional Doxycycline on Surgical Site Infection Prophylaxis in Abdominal Colorectal Surgery: The SHIELD I Randomized Clinical Trial.” Phase 3 SHIELD I trial results: A total of 104 patients experienced a primary outcome event: 45/485 in D-PLEX100 versus 59/489 in SoC. The clinically meaningful 23% event reduction in the D-PLEX100 treatment arm was not statistically significant. In the greater than 20 cm incision length pre-specified subgroup, a statistically significant 54% reduction in primary outcome events was observed in D-PLEX100 compared with SoC. Analysis of the key secondary efficacy outcome, incisional SSI, also indicated a 54.6% reduction in the greater than 20 cm incision subgroup. Exploratory analysis of the additional secondary efficacy outcomes indicated marked differences in favor of D-PLEX100 vs. SoC in the greater than 20 cm incision length subgroup. There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD I.