PolyPid Targets 2027 D-PLEX100 Launch, Unveils Diabetic Foot Infection Program

Key Points

• D-PLEX100 remains PolyPid’s near-term priority: The surgical-site infection prevention product is under FDA priority review with a November 28, 2026, action date, and PolyPid expects a U.S. launch in 2027 if approved. Its Azurity agreement includes $30 million upfront, potential milestones exceeding $290 million, and tiered royalties.
• International expansion and broader uses are planned: PolyPid expects a potential European decision in the second half of 2027 and launch in early 2028, while evaluating label expansions into additional abdominal, gastrointestinal, gynecological and other surgeries.
• PolyPid introduced PD01B for diabetic foot infections: The locally delivered doxycycline candidate is expected to enter first-in-human development in the second half of 2027 under the FDA’s 505(b)(2) pathway, with PolyPid retaining worldwide rights.

PolyPid NASDAQ: PYPD outlined plans to expand its commercial and development strategy through 2030 at an investor day, as the company approaches a November 28, 2026, FDA action date for its D-PLEX100 surgical-site infection prevention product candidate.

Chief Executive Officer Dikla Czaczkes Akselbrad said the company’s near-term focus remains D-PLEX100, which is under FDA priority review for use in patients undergoing colorectal surgery with large incisions. PolyPid expects a U.S. launch in 2027 if the product receives approval.

In July, PolyPid entered an exclusive licensing agreement with Azurity Pharmaceuticals covering D-PLEX100 in the United States and Canada. The company received a $30 million upfront payment and may receive more than $290 million in development, regulatory and sales milestones. PolyPid is also eligible for tiered net-sales royalties ranging from the mid-teens to the mid-20s, along with a pre-negotiated transfer price for product it manufactures and supplies to Azurity.

Azurity is preparing commercial capabilities including sales, national accounts, market access and medical-affairs functions, according to Akselbrad. The company said Azurity’s hospital footprint reaches more than 1,700 U.S. hospitals and academic centers.

D-PLEX100 Regulatory and Expansion Plans

PolyPid said all scheduled FDA interactions remain on track for D-PLEX100’s November 28 PDUFA goal date. The company also submitted an application to the Centers for Medicare & Medicaid Services for New Technology Add-On Payment status in October. A decision is expected in August 2027; if granted, the designation would provide additional reimbursement for hospitals using D-PLEX100 in inpatient settings.

Outside the U.S., PolyPid submitted a Marketing Authorization Application for D-PLEX100 to the European Medicines Agency in September, and the application was validated later that month. Akselbrad said the company expects an EMA decision in the second half of 2027 and a potential European launch in early 2028. PolyPid has regained full European commercial rights from ADVANZ PHARMA and is evaluating partnership opportunities in the region.

The company also plans to submit a Canadian new drug submission in 2027, contingent on a U.S. approval.

PolyPid and Azurity intend to evaluate potential label expansions beyond colorectal procedures following a possible approval. Initial areas under consideration include broader abdominal procedures, gastrointestinal surgeries and hysterectomies. Akselbrad said these categories represent roughly 4 million annual surgeries in the U.S., nearly half of which are open procedures. Other possible areas include breast reconstruction, post-weight-loss body contouring, trauma and fracture fixation, and lumbar fusion.

Under the Azurity agreement, Azurity would fund clinical development for agreed label-expansion programs while PolyPid would retain clinical and scientific responsibilities.

PD01B Targets Diabetic Foot Infections

PolyPid also introduced PD01B, a new product candidate designed to treat moderate-to-severe diabetic foot infections following wound debridement. The candidate uses the company’s Kynatrix platform to provide high concentrations of doxycycline locally in a diabetic foot wound over several weeks.

Chief Operating Officer, U.S. Ori Warshavsky said PolyPid expects to seek a pre-investigational new drug meeting with the FDA in the second half of 2027 and plans to begin a first-in-human study during the same period. PD01B would be developed under a new drug application using the 505(b)(2) pathway.

Warshavsky said PD01B differs from D-PLEX100 in its intended use, delivery profile, physician audience and commercial rights. While D-PLEX100 is designed to prevent infections after surgery and would be used by surgeons in the operating room, PD01B is intended as a treatment for diabetic foot infections and would be used by podiatrists and wound-care specialists. PolyPid retains worldwide rights to PD01B.

Management said it expects to leverage development and manufacturing knowledge from D-PLEX100, including its manufacturing facility, formulation experience, preclinical safety work and chemistry, manufacturing and controls processes. PolyPid recently filed a patent application related to PD01B, Warshavsky said.

Unmet Need in Diabetic Foot Infection

Dr. Warren Joseph, an adjunct clinical professor at Midwestern University and a podiatrist with infectious-disease fellowship training, described diabetic foot infections as a major clinical burden. He cited estimates that more than 40 million people in the U.S. have diagnosed or undiagnosed diabetes, with approximately one-third developing a foot ulcer during their lifetime.

Joseph said diabetic foot infection is the most common cause of hospitalization among people with diabetes. He noted that infections may progress to osteomyelitis and amputation, particularly in patients with poor circulation and other complications.

According to Joseph, locally delivered antibiotics could potentially offer high concentrations at the infection site while reducing systemic exposure, adverse effects and antibiotic-resistance concerns associated with oral or intravenous treatment. He said current clinical guidelines do not recommend routine topical antibiotic use because evidence remains limited, but the guidelines characterize that recommendation as conditional and cite a need for better controlled studies.

Joseph said doxycycline has an established safety profile and activity against several organisms commonly associated with diabetic foot infections, including certain staphylococcal and streptococcal infections. He added that any clinical trial would need careful design, including close follow-up of patients with moderate or severe infections.

Management said the ultimate PD01B registrational strategy, including potential endpoints, control arms and whether to pursue superiority or non-inferiority, will be determined after first-in-human data and discussions with the FDA. Akselbrad said treatment-focused pivotal studies in diabetic foot infection could involve substantially fewer patients than the 1,000-patient Phase III prevention studies conducted for D-PLEX100.

PolyPid’s broader pipeline also includes PD03A, a preclinical long-acting GLP-1 program in metabolic disease. Akselbrad said the company’s objective for that program is to generate robust preclinical data rather than advance it through the full clinical development process independently.

About PolyPid (NASDAQ:PYPD)

PolyPid Ltd. NASDAQ: PYPD is a clinical-stage biopharmaceutical company focused on developing locally administered therapies designed to provide controlled and sustained drug release at treatment sites. The company's technology is intended to maintain therapeutic drug concentrations over extended periods while limiting systemic exposure.

PolyPid's lead product candidate is D-PLEX100, an investigational formulation based on doxycycline and the company's proprietary PLEX polymeric matrix.

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