Full Press Release Details
PolyPid Announces Recruitment of First Patient
in Revised SHIELD II Phase 3 Trial Evaluating
Prevention of Abdominal Colorectal Surgical Site Infections
Company Recently Reached Agreement with FDA
Results Expected in Mid-2024
PETACH TIKVA, Israel, June
22, 2023 - PolyPid Ltd. (Nasdaq: PYPD)
("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced
that the first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase
3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The U.S. Food
and Drug Administration (FDA) recently accepted the Company's revised protocol for
SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions (> 20 cm).
SHIELD II will enroll an estimated 550 additional
patients beyond the 40 patients already recruited into the trial. Total recruitment time into the
trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded
interim analysis once a total of approximately 400 patients complete their 30-day follow-up.
recruitment of the first patient in the revised SHIELD II trial represents a significant milestone for our promising late-stage D-PLEX100
development program and our company," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "The
revised SHIELD II protocol is focused on the population of patients undergoing surgeries with large incisions, which showed a highly statistically
significant reduction of 54% in SSIs in SHIELD I. To further de-risk the trial, SHIELD II will primarily be conducted in the best performing
sites from SHIELD I as it relates to recruitment, patient monitoring and good clinical practice, and we have enhanced our internal clinical
operations capabilities. We are excited to resume the SHIELD II trial and look forward to providing updates on its progress in the coming
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 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.
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 a 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 treatment of solid tumors, beginning
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 the ability of D-PLEX100
to prevent SSIs, the expected total recruitment and timing of recruitment for the SHIELD II Phase 3 trial, the effectiveness
of measures to de-risk the trial and the timing of top-line results therefrom and potential 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 31, 2023. 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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this press release. PolyPid is not responsible for the contents of third-party websites.