PolyPid is preparing to submit a New Drug Application for D-PLEX100 after Phase 3 data showed a reduction in surgical site infections in colorectal procedures.

The company said it plans to begin a rolling NDA submission by the end of the month, supported by results from the Shield II Phase 3 trial and recent feedback from FDA. A waiver of the Prescription Drug User Fee Act fee has also been granted, removing a cost of around $4.3 million.

While the waiver supports near-term regulatory progress, the key driver for the submission is the late-stage clinical data. In the Shield II study, D-PLEX100 demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care in patients undergoing abdominal colorectal surgery with large incisions. The study met its primary and all key secondary endpoints.

D-PLEX100 is being developed to prevent surgical site infections through local delivery of antibiotics at the point of care. The product uses a controlled-release system designed to maintain high concentrations of doxycycline at the surgical site over an extended period. This approach is intended to reduce infection risk, including cases linked to antibiotic-resistant bacteria.

Surgical site infections remain a common complication in colorectal procedures and are associated with extended hospital stays and increased healthcare costs. Current prevention strategies rely on systemic antibiotics and sterile surgical techniques, but infection rates remain a concern, particularly in high-risk procedures.

Dikla Czaczkes Akselbrad, chief executive officer at PolyPid, said: “We are pleased to receive this PDUFA fee waiver days before our planned NDA submission.” She added that the company is progressing toward bringing D-PLEX100 to market following positive Phase 3 results and engagement with FDA.

D-PLEX100 has received Breakthrough Therapy designation from FDA for the prevention of surgical site infections in patients undergoing elective colorectal surgery. This status is intended to support faster development and review of therapies addressing serious conditions where there is unmet need.

The company said it is also progressing commercial planning alongside regulatory activities, including discussions on potential partnerships in the US market. However, the outcome of the NDA review will depend on FDA assessment of the full dataset, including safety, efficacy and manufacturing consistency.

If approved, D-PLEX100 could offer an alternative approach to infection prevention by targeting drug delivery directly at the surgical site rather than relying solely on systemic treatment. This strategy reflects a broader trend in drug development focused on localised therapies to improve efficacy while limiting systemic exposure.

The upcoming NDA submission marks a key step for PolyPid as it moves from late-stage development toward potential approval. The significance of the programme will depend on whether the Phase 3 results translate into regulatory approval and clinical adoption.