Full Press Release Details
granted Fast Track Designation from FDA for D-PLEX100
for Prevention of Surgical Site Infections in Abdominal Surgery
TIKVA, Israel, August 3, 2020 - PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage biopharmaceutical company focused
on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced
that D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention
of post abdominal surgery incisional infections.
FDA's Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat
serious and life threatening conditions and fill an unmet medical need. Fast Track designation allows for early and frequent communication
with the FDA throughout
the entire drug development and review process, and allows for a rolling review of a D-PLEX100's
New Drug Application ("NDA"). It also enables eligibility for Accelerated Approval and Priority Review, if relevant
Fast Track designation from the FDA represents an important achievement for our promising D-PLEX100 development program,"
said Amir Weisberg, PolyPid's CEO. "We view the Fast Track designation as important regulatory validation of the novelty
of our PLEX technology and the high clinical unmet need that currently exists in the ability to prevent surgical site infections
in complex surgical settings such as abdominal surgeries. We recently initiated our SHIELD I Phase 3 clinical trial of D-PLEX100
for the prevention of post-abdominal surgery incisional infections, and look forward to the opportunity to provide a safe
and effective solution for surgeons and their patients as quickly as possible."
lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged anti-bacterial
activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical
site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in
high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to
treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease
Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention
of post-abdominal surgery incisional infection.
a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release
therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are
designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites
in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead
product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs.
PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific
Officer of the company.
additional company information, visit www.polypid.com.
press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking
statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, timing, subject matter
and frequency of communications with the FDA, whether D-PLEX100 will be eligible for rolling review of its NDA and/or
priority review with the FDA, and providing a safe and effective solution for surgeons and
their patients as quickly as possible. Because such statements deal with future events and are based on PolyPid's
current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation
for D-PLEX100 for the prevention of surgical site infections, it cannot guarantee that it will be able to maintain
such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could
differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained
or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk
Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and
Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid
undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. 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.