Full Press Release Details
PolyPid Hosts KOL Call to Discuss Significant
Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on its Ongoing SHIELD
After a Reduction in Surgical Site Infection
(SSI) Rates During COVID, Rates are Now Increasing, Signaling a Return to Pre-COVID Levels
Known Procedure and Patient Risk-Factors Significantly
Increase the Risk of SSIs and Impact Payer Costs
Approximately 250 Patients of a Planned Total
of 600 Subjects Currently Enrolled in SHIELD II
Interim Analysis to be Conducted Once Approximately 400 Patients Complete
Their 30-Day Follow-up; Top-line Results Expected in the First Quarter of 2025
PETACH TIKVA, Israel, June 18, 2024 (GLOBE NEWSWIRE)
- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve
surgical outcomes, today hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of
surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100.
Charles E. Edmiston, Ph.D. (Emeritus Professor
of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs. Key
"Studies show traditional evidence-based
interventions have maximum benefit within the perioperative and immediate postoperative period. Building upon this, D-PLEX100
supports prolonged doxycycline concentrations within the surgical wound during and beyond this critical period and exceeds the minimum
inhibitory concentration for the most common surgical wound pathogens regardless of length of the surgical incision," said Dr. Edmiston.
"There remains an opportunity to improve upon the existing clinical standard of care to reduce the rate of SSIs in and beyond the
colorectal surgical setting, improving the patient experience and lowering costs for payers."
PolyPid also provided
an update on the enrollment of its ongoing Phase 3 SHIELD II trial of its lead product candidate, D-PLEX100. The
SHIELD II clinical study includes patients undergoing abdominal colorectal surgery with large incisions
and has now enrolled approximately 250 patients of a planned total of approximately 600 subjects. Approximately 50 centers are currently
open and recruiting patients. Top-line results are expected in the first quarter of 2025. The Company intends to conduct an unblinded
interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is anticipated to occur in the fourth
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 surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of
subjects with either an 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 Designation from the U.S. Food and Drug Administration for the prevention
of SSIs in patients undergoing elective 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.
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
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 potential benefits and advantages of D-PLEX100, that there remains an opportunity
to improve upon the existing clinical standard of care to reduce the rate of SSIs in and beyond the colorectal surgical setting, improving
the patient experience and lowering costs for payers, total recruitment time into the study and the timing of the top-line results and
an unblinded interim analysis. 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 ("SEC"), 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
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no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking
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