March 11, 2025 -- InvestorsHub NewsWire -- via Wall Street Wire -- Final Patient Enrolled in Pivotal Phase 3 Trial Following Highly Encouraging Safety Review; Small-Cap Biotech on Track for Mid-2025 Results and Potential FDA Fast-Track Submission; Market Opportunity Could Be Substantial as Surgical Infections Cost Healthcare Systems Billions Annually

PolyPid (Nasdaq: PYPD) announced today a significant achievement with the successful completion of enrollment in its pivotal SHIELD II Phase 3 trial. The 800-patient study evaluates D-PLEX100, the company's lead product candidate, for preventing infections after colorectal surgery—a critical healthcare challenge affecting millions of patients annually.

Repotedly, surgical site infections (SSIs) represent a massive market opportunity estimated at over $10 billion in the US and EU combined, with up to 30% of colorectal surgeries developing infections despite current preventive measures.

This key milestone follows an independent Data Safety Monitoring Board's highly positive recommendation after reviewing unblinded efficacy data from the first 430 enrolled patients. The board specifically recommended concluding the study at just 800 patients—the lowest sample size reassessment option available—which many analysts interpret as a potential signal of compelling efficacy trends.

According to the announcment, PolyPid is now on track to report top-line results by the end of Q2 2025, with plans to rapidly advance toward FDA submission leveraging coveted Fast Track and Breakthrough Therapy designations, which could significantly accelerate the approval timeline.

According to TipRanks, Wall Street analysts seem to maintain bullish outlooks on the small-cap biotech, with an average price target of $12.33 according to TipRanks data—representing potential significant upside from current trading levels around $2.74.

"We are excited to reach another critical milestone in our ongoing SHIELD II Phase 3 trial, reinforcing the positive trajectory of D-PLEX100's development," said Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "With top-line data expected by the end of the second quarter of 2025, we are preparing to engage with the FDA for a pre-NDA meeting to discuss a rolling NDA submission under the Breakthrough Therapy designation. Importantly, we remain in active discussions with multiple potential partners for the commercialization of D-PLEX100 in various regions, starting with the U.S."

The innovative technology behind D-PLEX100 involves a proprietary matrix that releases antibiotics directly at the surgical site for a full month—far exceeding the protection window of current preventive measures which typically last only hours. This extended protection addresses a major gap in current surgical infection prevention.

Beyond its lead program, PolyPid is also developing applications of its drug delivery platform for cancer treatment and recently announced a collaboration with ImmunoGenesis targeting solid tumors.

For those watching the biotech sector, PolyPid represents a late-stage company approaching a major catalyst with Fast Track and Breakthrough Therapy designations already secured from the FDA. The company's technology platform addresses a substantial unmet medical need in surgical care, with potential applications across multiple surgical specialties if successful.

With enrollment now complete in this pivotal trial, all eyes will be on the upcoming data readout expected before the end of Q2 2025, which could potentially transform both surgical practice and PolyPid's market position.

Click here to Read PolyPid's full announcment, titled: "PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections"

*Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by Wall Street Wire. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This report contains paid promotional content related to PolyPid and was produced as part of their paid subscription to Wall Street Wire distribution and promotional content platform. This report was not reviewed by PolyPid prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. We are not responsible for the price targets mentioned in this article nor do we it endorse them, they are quoted based on publicly available news reports. Readers are advised to refer to the full reports mentioned on various systems and the disclaimers/disclosures they may be subject to. 

SOURCE: Wall Street Wire

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