공시 • May 06
PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026 PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026 공시 • Apr 29
PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site Infection PolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. 공시 • Apr 14
PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local Release PolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. 공시 • Mar 31
Polypid Ltd Initiates D-Plex100 Nda Submission to Fda PolyPid Ltd. had initiated a New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100 for the prevention of surgical site infections in patients undergoing colorectal surgery. The NDA is being submitted under the FDA’s Fast Track designation, which allows for rolling review. The submission includes the Chemistry, Manufacturing and Controls and nonclinical sections of the NDA, with additional components, including the clinical section, expected to be submitted in the Second Quarter of 2026. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of surgical site infections, with additional potential to prevent surgical site infections caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections in patients undergoing elective colorectal surgery.