PolyPid to Present New Phase 3 SHIELD II Data Demonstrating D-PLEX₁₀₀ Sustained Local Release at ESCMID Global 2026
Rhea-AI Summary
PolyPid (Nasdaq: PYPD) will present Phase 3 SHIELD II pharmacokinetic data for D-PLEX100 at ESCMID Global 2026 on April 19, 2026. Key results show a sustained, controlled local doxycycline release detectable for 763 hours (~32 days) with plasma levels below 100 ng/mL, indicating minimal systemic exposure versus oral dosing.
The poster (P2740) is authored by Prof. Antonino Spinelli and presented by Eyal Shoshani in Session 05b on April 19, 12:00–13:30 CEST.
Positive
- Sustained release detected for 763 hours (~32 days)
- Minimal systemic exposure with plasma doxycycline <100 ng/mL
- Phase 3 SHIELD II pharmacokinetics presented at ESCMID Global 2026
Negative
- No clinical efficacy or infection‑rate outcomes reported in this PK data
- Comparative oral Cmax cited (1,613–2,600 ng/mL) but no direct clinical safety comparison
Key Figures
Market Reality Check
Peers on Argus
PYPD was down 1.37% pre-news. Momentum peers were mixed: CUE down 12.01%, PDSB down 3.70%, and VTVT up 6.13%. With two downside peers, today’s weakness fit broader biotech volatility rather than a PYPD‑specific move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 31 | NDA submission start | Positive | +4.0% | Began rolling NDA submission to FDA for D-PLEX₁₀₀ after SHIELD II success. |
| Mar 17 | PDUFA fee waiver | Positive | +3.6% | Received $4.3M PDUFA fee waiver and highlighted strong SHIELD II efficacy data. |
| Dec 03 | Pre-NDA minutes | Positive | +4.8% | FDA pre‑NDA minutes supported rolling NDA based on existing SHIELD II dataset. |
| Jun 16 | Warrant financing | Negative | -3.8% | Raised $26.7M via warrant exercises following SHIELD II success, implying dilution. |
| Jun 09 | Topline Phase 3 | Positive | +2.8% | Phase 3 SHIELD II met primary and secondary endpoints with strong infection reductions. |
Clinical and regulatory milestones for D-PLEX₁₀₀ have generally seen positive price alignment, with only the warrant-related funding event drawing a negative reaction.
Over the past year, PolyPid’s key news flow has centered on D‑PLEX₁₀₀ and the Phase 3 SHIELD II program. Positive topline data on Jun 9, 2025 and subsequent financing tied to SHIELD II marked an inflection toward NDA planning. FDA pre‑NDA minutes on Dec 3, 2025, a PDUFA fee waiver on Mar 17, 2026, and initiation of the rolling NDA on Mar 31, 2026 all drew constructive price reactions. Today’s PK-focused update fits this sequence of data-rich, filing‑oriented milestones.
Historical Comparison
In the last five clinical‑trial‑tagged releases, PYPD moved an average of 2.28%, typically higher on positive SHIELD II and NDA milestones. Today’s pharmacokinetic update continues the same program narrative but came against a modest pre‑news decline.
Clinical‑trial news shows a clear arc: SHIELD II topline success, financing to fund development, supportive FDA pre‑NDA feedback, a PDUFA fee waiver, and initiation of a rolling NDA for D‑PLEX₁₀₀. The new PK data further characterizes the same Phase 3 program by detailing local exposure and systemic levels.
Market Pulse Summary
This announcement adds quantitative depth to the SHIELD II Phase 3 story, showing D‑PLEX₁₀₀ maintained local doxycycline exposure for up to 763 hours while keeping plasma levels below 100 ng/mL. It complements prior milestones such as pre‑NDA FDA feedback, a PDUFA fee waiver, and the rolling NDA submission. Investors may focus on how these PK data support the mechanism during the critical 30‑day post‑surgical window and on future regulatory decisions.
Key Terms
pharmacokinetic medical
extended-release medical
doxycycline medical
Phase 3 medical
Cmax medical
therapeutic drug monitoring medical
AI-generated analysis. Not financial advice.
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 Cmax 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
| Poster Title: | Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial |
| Presenter: | Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. |
| Lead Author: | Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy |
| Poster Details: | #P2740 (Presented at: Poster Hall B3) |
| Session: | 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring |
| Date/Time: | Sunday, April 19, 2026 | 12:00 – 13:30 CEST |
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
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
