Woburn, MA, July 21, 2026 (GLOBE NEWSWIRE) -- Azurity Pharmaceuticals, a privately held specialty pharmaceutical company, today announced plans to commercialize D-PLEX100 upon approval in the United States and Canada for the prevention of abdominal colorectal surgical site infections (“SSIs”) in partnership with PolyPid Ltd. (“PolyPid”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, who will manufacture and supply D-PLEX100.
SSIs remain among the most common healthcare-associated infections and may lead to prolonged hospital stays, higher readmission rates, increased healthcare costs, and worse patient outcomes.1,2 SSIs represent a significant clinical and economic burden across the U.S. health system:
- Patients who develop an SSI experience longer hospital stays, higher readmission rates, and higher medical costs than similar patients without an SSI.3
- Recent U.S. hospital analyses report that SSIs add approximately $30,689 in incremental hospital cost and 11.6 additional days of length of stay per affected admission.4
- In a large Veterans Affairs analysis, deep SSIs were associated with nearly 2x greater risk-adjusted costs versus comparable surgical admissions without SSI.3
- Among major healthcare-associated infections in the U.S., SSIs and C. difficile together account for approximately 79% of total attributable HAI costs.4
- SSIs are a leading cause of post-operative readmissions, including after colorectal surgery.5
D-PLEX100 is designed to provide local, prolonged and controlled antibacterial activity directly at the surgical site and is being evaluated for the prevention of abdominal colorectal SSIs. The U.S. Food and Drug Administration (“FDA”) acceptance of the D-PLEX100 New Drug Application (“NDA”) is expected in August 2026.
Azurity and PolyPid have jointly agreed to explore potential label expansion of D-PLEX₁₀₀ in the U.S. and Canada into additional SSI indications beyond abdominal colorectal, with Azurity providing funding for these additional clinical development programs. PolyPid will retain global commercial rights to D-PLEX100 outside of the U.S. and Canada, manufacturing rights worldwide, and full ownership of its PLEX platform, Kynatrix™ technology and associated pipeline assets.
“At Azurity, we believe meaningful innovation is measured by the difference a therapy makes in the realities of patient care,” said Ronald Scarboro, Chief Executive Officer of Azurity Pharmaceuticals. “D-PLEX100 is a differentiated therapy addressing an important unmet need, and we are excited to partner with PolyPid to help bring it to patients in the United States and Canada, if approved. Our commercial model is built to support specialized therapies like this— connecting the right treatment with the right healthcare professionals and patients through efficient, focused execution. Together, we look forward to expanding access to this important therapy while exploring opportunities to expand its impact and future clinical development.”
“This partnership is a defining step in PolyPid’s transition into a commercial-stage company, and Azurity is the right partner to bring D-PLEX100 to U.S. and Canadian patients, hospitals and surgeons,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “We believe that Azurity’s first-in-class commercial model and demonstrated commercial execution will be invaluable in expanding access to D-PLEX100, if approved.”
About D-PLEX100
D-PLEX100 is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site and is being evaluated for the prevention of abdominal colorectal surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, is designed to pair with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. In the Phase 3 SHIELD II trial, D-PLEX100 recently demonstrated positive results in achieving its primary end point and a 60% (p= 0.0013) relative risk reduction at the secondary end point in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
References:
- Shambhu S, Gordon AS, Liu Y, et al. The burden of healthcare utilization, cost, and mortality associated with select surgical site infections. Jt Comm J Qual Patient Saf. 2024;50(12):857-866. doi:10.1016/j.jcjq.2024.08.005.
- Ai C, Jung M, Bastow S, et al. Clinical outcomes and hospital-reported cost associated with surgical site infections and the co-occurrence of hospital-onset bacteremia and fungemia across US hospitals. Infect Control Hosp Epidemiol. 2025;46(4):391-397. doi:10.1017/ice.2025.13.
- Schweizer ML, Cullen JJ, Perencevich EN, et al. Costs Associated With Surgical Site Infections in Veterans Affairs Hospitals. JAMA Surg. 2014;149(6):575-581. doi:10.1001/jamasurg.2013.4663.
- Forrester JD, Maggio PM, Tennakoon L. Cost of Health Care-Associated Infections in the United States. J Patient Saf. 2022;18(2):e477-e479. doi:10.1097/PTS.0000000000000845.
- Shah R, Pavey E, Ju M, et al. Evaluation of readmissions due to surgical site infections: A potential target for quality improvement. Am J Surg. 2017;214(5):773-779.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 50 medicines across 10 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and follow on LinkedIn.
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX₁₀₀, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of abdominal colorectal surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow on Twitter (X) and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Words such as “expected,” “anticipated,” “plans,” and similar expressions or variations of such words are intended to identify forward looking statements. For example, PolyPid and Azurity are using forward-looking statements when discussing the timing of FDA acceptance and potential approval of the NDA for D-PLEX100; the anticipated timing of a U.S. commercial launch of D-PLEX100, including the target of the first quarter of 2027; the potential for label expansion of D-PLEX100 into indications beyond abdominal colorectal surgery and the funding of related clinical development; the ability to successfully commercialize D-PLEX100, if approved, in the U.S. and Canada; the therapeutic and commercial potential of D-PLEX100, including its ability to reduce the incidence of SSIs and that D-PLEX100 is a differentiated therapy addressing an important unmet need. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. If PolyPid or Azurity do update one or more forward-looking statements, no inference should be drawn that PolyPid or Azurity will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid and Azurity are not responsible for the contents of third-party websites.
Azurity Pharmaceuticals Media Contacts
Media Relations
media@azurity.com
PolyPid Investor Relations and Media Contacts
Ori Warshavsky
908-858-5995
IR@Polypid.com
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com
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Media Relations Azurity Pharmaceuticals media@azurity.com
