PolyPid to Present New Phase 3 SHIELD II Data Demonstrating D-PLEX₁₀₀ Sustained Local Release at ESCMID Global 2026

Analysis demonstrates D-PLEX₁₀₀ prolonged delivery mechanism ability to deliver continuous release of doxycycline for 30 days at the surgical incision site

PETACH TIKVA, Israel, April 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX₁₀₀ at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026 (formerly known as ECCMID), the world’s leading congress for clinical microbiology and infectious diseases, taking place on April 17-21, 2026, in Munich, Germany.

The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid.

Key findings from the SHIELD II analysis:

• Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX₁₀₀ during surgery.
  
  
  

Figure 1. Mean (+ standard deviation) plasma doxycycline concentration versus time profile

• Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where C_max levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg¹ and 2,600 ng/mL for 200 mg² doses).
  
  

“These pharmacokinetic results further support the mechanism of D-PLEX₁₀₀, which is designed to deliver sustained and controlled antibiotic exposure for 30 days directly at the surgical incision site,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “The findings reinforce the potential of D-PLEX₁₀₀ to address a key limitation of conventional systemic prophylactic antibiotics by maintaining local antimicrobial activity during the critical 30 days post-surgical period when infections most commonly develop.”

ESCMID Global 2026 Presentation Details

The abstract will be available on www.polypid.com once the conference concludes.

About D-PLEX₁₀₀
D-PLEX₁₀₀, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX₁₀₀ into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs 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. D-PLEX₁₀₀ recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction 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.

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 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 us 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 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential mechanism and benefits of D-PLEX₁₀₀, including its ability to deliver sustained and controlled antibiotic exposure for 30 days directly at the surgical incision site, and the potential role of D-PLEX₁₀₀ in improving the prevention of surgical site infections. 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. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company 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 is not responsible for the contents of third-party websites.

Company Contact:
PolyPid Ltd.
Ori Warshavsky
908-858-5995
IR@Polypid.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com

¹ Gschwend MH, Martin W, Erenmemişoğlu A, et. al.. Pharmacokinetics and Bioequivalence Study of Doxycycline Capsules in Healthy Male Subjects. Arzneimittelforschu 2007;57(6):347-51
² Vibramycin (doxycycline hyclate) [capsules]: Full Prescribing Information. New York, NY: Pfizer Labs; August 2025.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6016c990-606d-49e6-a7a8-4d88bace509a

Figure 1

Mean (+ standard deviation) plasma doxycycline concentration versus time profile

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.