Full Press Release Details
PolyPid Announces Successful Completion of Enrollment
in Phase 3 SHIELD II Trial of D-PLEX100 for the Prevention
of Abdominal Colorectal Surgical Site Infections
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 -- PolyPid
("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."
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.
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.
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
For additional Company information, please
visit http://www.polypid.com and
Forward-looking Statements
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.