PolyPid Nears FDA Decision for D-PLEX100 After Strong Phase III Data

Key Points

• PolyPid is nearing the FDA’s November 28 PDUFA decision on D-PLEX100, an implantable doxycycline formulation designed to provide 30 days of localized protection against surgical-site infections after open colorectal surgery.
• In a 1,000-patient Phase III trial, D-PLEX100 reduced the primary composite outcome of infection, mortality and reoperation to 10.9% from 18% with standard care, while surgical-site infections fell to 4% from 10%.
• If approved, Azurity Pharmaceuticals plans an early 2027 U.S. and Canadian launch, while PolyPid will manufacture the product. The agreement includes $30 million in upfront and near-term milestones, more than $190 million in potential additional milestones, and tiered royalties.

PolyPid NASDAQ: PYPD is approaching a November 28 PDUFA date for D-PLEX100, its lead product candidate for preventing surgical site infections in patients undergoing colorectal surgery, Chief Executive Officer Dikla Czaczkes Akselbrad said during the Lytham Partners Fall 2026 Investor Conference.

The company submitted its New Drug Application earlier this year, and the FDA accepted the filing in July, setting the November 28 action date. PolyPid also plans to submit an application for the New Technology Add-on Payment, or NTAP, program in October and has filed for European approval, which Akselbrad said could take about a year.

D-PLEX100 and Kynatrix platform

D-PLEX100 combines doxycycline with PolyPid’s proprietary Kynatrix drug-delivery platform. Akselbrad described Kynatrix as a self-assembling matrix made from alternating polymer and lipid layers that is designed to release a drug locally over an extended period. The platform contains no chemical bond between the components, she said.

In the case of D-PLEX100, the matrix is applied along a surgical incision and is designed to provide 30 days of localized antibiotic coverage. PolyPid designed the duration to align with the Centers for Disease Control and Prevention’s 30-day definition of surgical site infection for most procedures, according to Akselbrad.

The product is intended initially for use in open colorectal procedures, where incisions can range from about 7 centimeters to more than 10 centimeters, she said. Dosing is based on incision length, with one vial used for incisions up to 10 centimeters, two vials for 10- to 20-centimeter incisions, and three vials for longer incisions.

Akselbrad said D-PLEX100 has received Breakthrough Therapy designation, Fast Track designation and three Qualified Infectious Disease Product, or QIDP, designations. The NDA is proceeding under the FDA’s 505(b)(2) regulatory pathway.

Phase III data

PolyPid’s pivotal global Phase III study enrolled 1,000 patients undergoing colorectal resection. According to Akselbrad, the trial compared D-PLEX100 plus standard care with standard care, which included systemic antibiotics and mechanical bowel preparation.

The company reported that the primary composite endpoint of surgical site infection, mortality and reoperation occurred in 10.9% of patients receiving D-PLEX100, compared with 18% in the standard-care group. Akselbrad said the result represented a 40% reduction and had a p-value of 0.0039.

She also said the surgical site infection rate was reduced from 10% in the control group to 4% with D-PLEX100, representing a 60% reduction, with a p-value of 0.0013. Akselbrad said surgeons have indicated that the resulting infection rate is below levels they generally expect in minimally invasive procedures.

Azurity commercialization agreement

PolyPid has selected Azurity Pharmaceuticals to commercialize D-PLEX100 in the U.S. and Canada, should the product receive approval. Azurity, a privately held company focused on hospital-used medicines, will be responsible for commercialization, while PolyPid will manufacture the product at its GMP facility.

PolyPid retained rights outside the U.S. and Canada. The companies also plan to jointly pursue potential label expansions beyond colorectal and abdominal surgery, including orthopedic and breast surgery applications. Azurity will fund those expansion efforts, according to Akselbrad.

The agreement provided PolyPid with $30 million in upfront and near-term milestones tied to NDA acceptance, which Akselbrad said had already been secured. The deal also includes more than $190 million in development and sales milestones, tiered royalties ranging from the mid-teens to the mid-20% range, and a negotiated transfer price for product supplied by PolyPid.

Akselbrad said Azurity is targeting an early 2027 launch if D-PLEX100 is approved. She added that hospitals may have an additional incentive to adopt the therapy through the NTAP program, which can provide reimbursement of up to 75% of a drug’s cost during its first two to three years.

About PolyPid (NASDAQ:PYPD)

PolyPid Ltd. is an Israeli clinical-stage biopharmaceutical company developing locally administered therapies designed to provide controlled and sustained drug delivery at treatment sites. The company's proprietary PLEX polymer-lipid encapsulation matrix is intended to release therapeutic agents over an extended period, with the goal of improving treatment effectiveness and reducing the need for repeated systemic dosing.

PolyPid's lead product candidate is D-PLEX100, an investigational formulation containing doxycycline that is designed for administration at surgical sites.

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