PolyPid, Azurity Pharmaceuticals Agree to Exclusive Commercial Partnership in US and Canada

Editor’s Take: Prevention of surgical site infections, particularly in colorectal surgery, is considered an important unmet medical need.

PolyPid and Azurity Pharmaceuticals are partnering to commercialize D-PLEX₁₀₀, preventing surgical site infections (SSIs), in the United States and Canada.

D-PLEX₁₀₀, PolyPid’s lead product candidate, is meant for prolonged, controlled antibacterial activity directly at a surgical site. The therapy already received Breakthrough Designation from the U.S. FDA for SSI prevention in patients undergoing elective colorectal surgery. Additionally, PolyPid expects the FDA’s acceptance of a New Drug Application (NDA) in August 2026.

Terms of Exclusivity

In the exclusive agreement, PolyPid and Azurity may jointly pursue label expansion of D-PLEX₁₀₀ beyond abdominal SSI indications.

When D-PLEX₁₀₀ is administered into a surgical site, PolyPid explains, the company’s Kynatrix delivery technology ideally pairs with APIs. This enables a prolonged and continuous release of doxycycline, a broad-spectrum antibiotic, resulting in high local concentrations for 30 days. A recent Phase III trial yielded positive results.

PolyPid and Azurity CEOs React

“This partnership is a defining step in PolyPid’s transition into a commercial-stage company,” PolyPid CEO Dikla Czaczkes Akselbrad said. “Azurity is the right partner to bring D-PLEX₁₀₀ to U.S. and Canadian patients, hospitals and surgeons.”

“D-PLEX₁₀₀ is a differentiated therapy addressing an important unmet need,” Azurity Pharmaceuticals CEO Ronald Scarboro said. “We are excited to partner with PolyPid to help bring it to patients in the U.S. and Canada, if approved.”

PolyPid will receive a $15 million upfront payment, plus an additional $15 million upon the FDA’s NDA acceptance. The company could then receive up to $300 million more for regulatory, development, and sales-based milestones.

Azurity is providing funding for any additional clinical development programs. PolyPid retains global commercial rights to D-PLEX₁₀₀ outside the U.S. and Canada, manufacturing rights worldwide, and full ownership of Kynatrix.