PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid (Nasdaq: PYPD) has completed enrollment in the SHIELD II Phase 3 trial for D-PLEX₁₀₀, targeting the prevention of surgical site infections in abdominal colorectal surgery patients. The independent Data Safety Monitoring Board (DSMB) recommended concluding the study at 800 patients after analyzing unblinded efficacy data from the first 430 participants.
The company expects to report top-line results by Q2 2025, and if positive, plans to submit a New Drug Application (NDA) to the FDA. The submission will leverage the FDA's Fast Track and Breakthrough Therapy designations. PolyPid is currently engaged in discussions with potential partners for D-PLEX₁₀₀'s commercialization across various regions, with initial focus on the U.S. market.
PolyPid (Nasdaq: PYPD) ha completato l'arruolamento nella fase 3 dello studio SHIELD II per D-PLEX₁₀₀, mirato alla prevenzione delle infezioni del sito chirurgico nei pazienti sottoposti a intervento chirurgico addominale per colite. Il Comitato Indipendente di Monitoraggio della Sicurezza dei Dati (DSMB) ha raccomandato di concludere lo studio a 800 pazienti dopo aver analizzato i dati di efficacia non mascherati dei primi 430 partecipanti.
L'azienda prevede di riportare risultati preliminari entro il secondo trimestre del 2025 e, se positivi, pianifica di presentare una Domanda di Nuovo Farmaco (NDA) alla FDA. La presentazione sfrutterà le designazioni di Fast Track e Breakthrough Therapy della FDA. PolyPid è attualmente impegnata in discussioni con potenziali partner per la commercializzazione di D-PLEX₁₀₀ in diverse regioni, con un focus iniziale sul mercato statunitense.
PolyPid (Nasdaq: PYPD) ha completado la inscripción en el ensayo SHIELD II de fase 3 para D-PLEX₁₀₀, dirigido a la prevención de infecciones en el sitio quirúrgico en pacientes sometidos a cirugía abdominal colorrectal. La Junta Independiente de Monitoreo de Seguridad de Datos (DSMB) recomendó concluir el estudio con 800 pacientes tras analizar los datos de eficacia no enmascarados de los primeros 430 participantes.
La compañía espera informar resultados preliminares para el segundo trimestre de 2025 y, si son positivos, planea presentar una Solicitud de Nuevo Medicamento (NDA) a la FDA. La presentación aprovechará las designaciones de Fast Track y Breakthrough Therapy de la FDA. PolyPid está actualmente en conversaciones con socios potenciales para la comercialización de D-PLEX₁₀₀ en varias regiones, con un enfoque inicial en el mercado estadounidense.
PolyPid (Nasdaq: PYPD)는 복부 대장 수술 환자의 수술 부위 감염 예방을 목표로 하는 D-PLEX₁₀₀에 대한 SHIELD II 3상 시험의 등록을 완료했습니다. 독립 데이터 안전 모니터링 위원회(DSMB)는 첫 430명의 참가자로부터 비블라인드 효능 데이터를 분석한 후 800명의 환자로 연구를 종료할 것을 권장했습니다.
회사는 2025년 2분기까지 주요 결과를 보고할 것으로 예상하고 있으며, 긍정적인 결과가 나올 경우 FDA에 신약 신청(NDA)을 제출할 계획입니다. 이 제출은 FDA의 패스트 트랙 및 혁신 치료 지정 제도를 활용할 것입니다. PolyPid는 현재 D-PLEX₁₀₀의 상업화를 위해 잠재적인 파트너와 논의 중이며, 초기 초점은 미국 시장에 맞춰져 있습니다.
PolyPid (Nasdaq: PYPD) a terminé l'inscription dans l'
L'entreprise prévoit de publier les résultats préliminaires d'ici le deuxième trimestre 2025 et, si les résultats sont positifs, envisage de soumettre une Demande de Nouveau Médicament (NDA) à la FDA. La soumission tirera parti des désignations Fast Track et Breakthrough Therapy de la FDA. PolyPid est actuellement en discussion avec des partenaires potentiels pour la commercialisation de D-PLEX₁₀₀ dans différentes régions, en se concentrant d'abord sur le marché américain.
PolyPid (Nasdaq: PYPD) hat die Rekrutierung in die SHIELD II Phase 3 Studie für D-PLEX₁₀₀ abgeschlossen, die auf die Prävention von chirurgischen Wundinfektionen bei Patienten mit abdominaler kolorektaler Chirurgie abzielt. Das unabhängige Daten-Sicherheitsüberwachungskomitee (DSMB) empfahl, die Studie nach der Analyse der unmaskierten Wirksamkeitsdaten der ersten 430 Teilnehmer mit 800 Patienten abzuschließen.
Das Unternehmen erwartet, bis zum 2. Quartal 2025 erste Ergebnisse zu berichten, und plant, bei positiven Ergebnissen einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA einzureichen. Die Einreichung wird die Fast-Track- und Breakthrough-Therapie-Bezeichnungen der FDA nutzen. PolyPid führt derzeit Gespräche mit potenziellen Partnern zur Vermarktung von D-PLEX₁₀₀ in verschiedenen Regionen, wobei der erste Fokus auf dem US-Markt liegt.
- DSMB recommended early trial completion at minimum sample size after positive efficacy data review
- FDA Fast Track and Breakthrough Therapy designations could expedite approval process
- Active discussions ongoing with multiple potential commercialization partners
- None.
Last Patient Enrolled Following Positive Recommendation by DSMB to Conclude Enrollment of Phase 3 Trial at 800 Patients; Top-line Results Expected by End of Q2 2025 and, if Positive, Expected to be Followed by Submission of an NDA to the FDA Leveraging the Company’s Fast-Track and Breakthrough Therapy Designations
PETACH TIKVA, Israel, March 11, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the independent Data Safety Monitoring Board (“DSMB”), which, after analyzing unblinded efficacy data from the first 430 enrolled patients in the trial, recommended concluding the study upon enrollment of 800 patients, the lowest sample size reassessment stop after the minimum planned number of patients.
The Company anticipates reporting top-line results by the end of the second quarter of 2025. If the Phase 3 data are positive, PolyPid expects to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”), leveraging the FDA’s Fast Track and Breakthrough Therapy designations.
“We are excited to reach another critical milestone in our ongoing SHIELD II Phase 3 trial, reinforcing the positive trajectory of D-PLEX100’s development,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “With top-line data expected by the end of the second quarter of 2025, we are preparing to engage with the FDA for a pre-NDA meeting to discuss a rolling NDA submission under the Breakthrough Therapy designation. Importantly, we remain in active discussions with multiple potential partners for the commercialization of D-PLEX100 in various regions, starting with the U.S.”
About SHIELD II
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.
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 SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology 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 received Breakthrough Therapy, Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of SSIs in patients undergoing abdominal colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
For additional Company information, please visit http://www.polypid.com and follow us on Twitter 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 timing of anticipated reporting of top-line results, that upon potential positive Phase 3 data, the Company anticipates submission of an NDA leveraging the advantages of Fast Track and Breakthrough Therapy designations, the intention to pursue a pre-NDA meeting with the FDA to discuss a rolling NDA submission, and discussions with multiple potential partners for the commercialization of D-PLEX100 in various regions, starting with the U.S. 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 26, 2025. 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.
Contacts:
PolyPid Ltd.
Ori Warshavsky
COO – US
908-858-5995
IR@Polypid.com
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
BRitchie@lifesciadvisors.com
FAQ
When will PolyPid (PYPD) release SHIELD II Phase 3 trial results for D-PLEX₁₀₀?
How many patients were enrolled in PolyPid's SHIELD II Phase 3 trial?
What regulatory designations does PolyPid's D-PLEX₁₀₀ have from the FDA?
What is the purpose of PolyPid's D-PLEX₁₀₀ SHIELD II trial?
