PolyPid's Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to Continue with DSMB Approval and $41M Private Placement

PolyPid Ltd., a biopharmaceutical company focused on enhancing surgical outcomes, has made a significant announcement regarding its ongoing SHIELD II Phase 3 trial. This trial is designed to evaluate the efficacy of D-PLEX100 in preventing surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions. Following an independent review by the Data Safety Monitoring Board (DSMB), the study has been advised to conclude upon enrolling 800 patients, indicating promising signals of efficacy.

To date, the trial has successfully enrolled 630 patients, with the remaining 170 expected to be enrolled by the first quarter of 2025. The company anticipates releasing top-line results in the second quarter of 2025. If the Phase 3 trial data proves positive, PolyPid plans to submit a New Drug Application (NDA) for D-PLEX100, leveraging its Fast Track and Breakthrough Therapy designations previously granted by the FDA.

The DSMB's recommendation follows an interim analysis of unblinded efficacy data from the first 430 enrolled patients. The Board had the option to recommend stopping the trial due to futility or overwhelming efficacy or to reassess the sample size up to a maximum of 1,100 patients. Instead, the suggestion to conclude upon 800 enrollments underscores a favorable outlook. Dikla Czaczkes Akselbrad, PolyPid’s CEO, remarked on the positive implications of this guidance, highlighting the increased probability of success for the trial and the potential to confirm the treatment benefits of D-PLEX100 conclusively.

PolyPid is also preparing for several strategic moves, including advancing its planned NDA and Marketing Authorization Application (MAA) submissions, initiating pre-launch activities, and accelerating partnership discussions both within and outside the United States.

In financial developments, PolyPid has secured a private placement financing agreement worth $14.5 million, priced at $3.22 per share. This move, led by existing institutional shareholders, will result in the purchase of nearly 4.5 million ordinary shares or pre-funded warrants. Additionally, investors will receive warrants to acquire up to 6.7 million ordinary shares at an exercise price of $4.00 per share. The warrants are set to expire either nine months from issuance or 10 trading days after the announcement of the SHIELD II trial’s top-line results. The exercise of these warrants could yield up to $27 million in gross proceeds.

The private placement, expected to close by December 26, 2024, aims to support the ongoing SHIELD II Phase 3 clinical trial, as well as general corporate needs and working capital. This financing is set to extend PolyPid’s cash runway into the third quarter of 2025, surpassing the anticipated timeline for top-line results from SHIELD II.

D-PLEX100, PolyPid’s leading product candidate, utilizes the company’s proprietary PLEX technology to deliver prolonged and controlled antibacterial activity directly at surgical sites. This approach aims to maintain high concentrations of doxycycline, a broad-spectrum antibiotic, for up to 30 days, potentially preventing infections, including those caused by antibiotic-resistant bacteria.

PolyPid continues to drive forward in its mission to enhance surgical outcomes with locally administered, controlled-release therapeutics. Alongside D-PLEX100, the company is exploring the preclinical efficacy of OncoPLEX, targeting solid tumors such as glioblastoma. Through its innovative approaches, PolyPid remains committed to advancing healthcare solutions and expanding its global impact in the biopharmaceutical sector.