PolyPid Enrolls Last Patient in SHIELD II Phase 3 Trial
Ticker: PYPD · Form: 6-K · Filed: Oct 1, 2024 · CIK: 1611842
| Field | Detail |
|---|---|
| Company | Polypid Ltd. (PYPD) |
| Form Type | 6-K |
| Filed Date | Oct 1, 2024 |
| Risk Level | medium |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | neutral |
Sentiment: neutral
Topics: clinical-trial, phase-3, enrollment-milestone
TL;DR
PolyPid hit a key enrollment milestone for its D-PLEX 100 surgical infection trial.
AI Summary
PolyPid Ltd. announced on October 1, 2024, that the last patient has been enrolled for the planned unblinded interim analysis of their SHIELD II Phase 3 trial. This trial is evaluating D-PLEX 100 for the prevention of abdominal colorectal surgical site infections.
Why It Matters
This milestone is crucial for the SHIELD II trial, bringing PolyPid closer to potential data readouts for D-PLEX 100, a drug aimed at preventing serious post-surgical infections.
Risk Assessment
Risk Level: medium — The company is in a Phase 3 trial, which is a critical but still uncertain stage before potential market approval.
Key Players & Entities
- PolyPid Ltd. (company) — Registrant
- D-PLEX 100 (drug) — Drug being evaluated
- SHIELD II (trial) — Phase 3 trial name
- October 1, 2024 (date) — Date of announcement
FAQ
What is the purpose of the SHIELD II Phase 3 trial?
The SHIELD II Phase 3 trial is evaluating D-PLEX 100 for the prevention of abdominal colorectal surgical site infections.
What significant event occurred on October 1, 2024, for PolyPid Ltd.?
On October 1, 2024, PolyPid Ltd. announced that the last patient was enrolled for the planned unblinded interim analysis in the ongoing SHIELD II Phase 3 trial.
What is the drug being tested in the SHIELD II trial?
The drug 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 is the next step after enrolling the last patient for the interim analysis?
The filing indicates that the enrollment of the last patient is for a planned unblinded interim analysis, suggesting that data from this analysis will be reviewed.
Filing Stats: 327 words · 1 min read · ~1 pages · Grade level 11.1 · Accepted 2024-10-01 07:05:28
Filing Documents
- ea0216098-6k_polypid.htm (6-K) — 12KB
- ea021609801ex99-1_polypid.htm (EX-99.1) — 16KB
- 0001213900-24-083641.txt ( ) — 30KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. POLYPID LTD. Date: October 1, 2024 By: /s/ Dikla Czaczkes Akselbrad Name: Dikla Czaczkes Akselbrad Title: Chief Executive Officer 3