PolyPid Announces Last Patient In for Planned Unblinded Interim Analysis in the Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PYPD 10.01.2024
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Recent News
- 12.24.2024 - PolyPid Announces Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to 800 Patients with a Concurrent Private Placement of up to $41 Million
- 12.11.2024 - PolyPid Announces Research and Development Collaboration with ImmunoGenesis Leveraging PLEX Technology to Enhance Cancer Immunotherapy
- 11.29.2024 - PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-Compliance
Recent Filings
Unblinded Interim Analysis to be ConductedDuring the
Top-line Results Anticipated in First Quarter of 2025
PETACH TIKVA,
Approximately 430 subjects have been enrolled to date in the SHIELD II Phase 3 trial.
“We are pleased to reach this important milestone in our ongoing SHIELD II Phase 3 trial and look forward to the unblinded interim analysis later this quarter,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Enrollment in the study is accelerating and we remain on track to announce top-line results from SHIELD II in the first quarter of 2025. Importantly,
Under the terms of the private placement financing that was closed in
About SHIELD IISHIELD 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-PLEX100administered 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 enrolls patients in centers in the United States, Europe and Israel.
About D-PLEX100D-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-PLEX100into 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-PLEX100received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
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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 expected timing for top-line results from the SHIELD II trial and of the unblinded interim analysis, that enrollment for the study remains on track, and the Company’s expected cash runway and the potential to secure additional funds if all of the warrants issued through the January PIPE and August PIPE are exercised. 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 March 6, 2024. 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.
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