PolyPid Completes Enrollment in Phase 3 D-PLEX 100 Surgical Infection Trial
Ticker: PYPD · Form: 6-K · Filed: Mar 11, 2025 · CIK: 1611842
| Field | Detail |
|---|---|
| Company | Polypid Ltd. (PYPD) |
| Form Type | 6-K |
| Filed Date | Mar 11, 2025 |
| Risk Level | medium |
| Sentiment | neutral |
Sentiment: neutral
Topics: clinical-trial, enrollment-completion, drug-development
TL;DR
PolyPid enrolled all patients for its big Phase 3 infection trial. Next up: data!
AI Summary
PolyPid Ltd. announced on March 11, 2025, the successful completion of patient enrollment for its Phase 3 SHIELD II trial. This trial is evaluating D-PLEX 100 for the prevention of abdominal colorectal surgical site infections. The company is a foreign private issuer based in Israel.
Why It Matters
Successful completion of enrollment is a key milestone, bringing the company closer to potential data readouts and regulatory submissions for D-PLEX 100, which aims to prevent serious post-surgical infections.
Risk Assessment
Risk Level: medium — Clinical trial progress is a significant driver, but success is not guaranteed, and regulatory approval is still pending.
Key Players & Entities
- PolyPid Ltd. (company) — Registrant
- D-PLEX 100 (product) — Drug candidate being tested
- SHIELD II Trial (trial) — Phase 3 clinical trial
- March 11, 2025 (date) — Date of press release
FAQ
What is the primary purpose of the SHIELD II trial?
The SHIELD II trial is evaluating D-PLEX 100 for the prevention of abdominal colorectal surgical site infections.
What milestone did PolyPid announce on March 11, 2025?
PolyPid announced the successful completion of patient enrollment in its Phase 3 SHIELD II trial.
What is the drug candidate being tested in the SHIELD II trial?
The drug candidate being tested is D-PLEX 100.
What type of infections is D-PLEX 100 intended to prevent?
D-PLEX 100 is intended to prevent abdominal colorectal surgical site infections.
What form is attached to this 6-K filing?
A press release issued by PolyPid Ltd. on March 11, 2025, titled 'PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX 100 for the Prevention of Abdominal Colorectal Surgical Site Infections.'
Filing Details
This Form 6-K (Form 6-K) was filed with the SEC on March 11, 2025 regarding PolyPid Ltd. (PYPD).