PepGen Inc. Provides Update on Planned Initiation of Phase 1 Study of PGN-EDODM1 in Myotonic Dystrophy Type 1
2023年6月14日 - 5:05AM
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company
advancing the next generation of oligonucleotide therapies with the
goal of transforming the treatment of severe neuromuscular and
neurological diseases, today announced that while it awaits
receipt of an official clinical hold letter from the U.S. Food and
Drug Administration (FDA), the Company is withdrawing its prior
guidance with respect to the timeline for initiating a Phase 1
study of PGN-EDODM1 in patients with myotonic dystrophy type 1
(DM1) in the first half of 2023 in any geography.
“After careful consideration, we decided to pause additional
regulatory filings for clearance to initiate a Phase 1 study of
PGN-EDODM1 in order to address the official hold letter once
received from the FDA,” said James McArthur, Ph.D., President and
CEO of PepGen. “People living with DM1 are eager for innovative,
potential new treatment options for this serious disease, and
transparency with that community and PepGen’s shareholders is
always a top priority for our team. We will continue to work
closely with the FDA to lift the clinical hold whilst we remain
fully committed to initiating a Phase 1 study of PGN-EDODM1 as
quickly as feasible. We also remain very focused on advancing our
Phase 2 CONNECT1-EDO51 study in our lead program in Duchenne
muscular dystrophy, which was cleared to proceed last month by
Health Canada.”
About PepGen
PepGen Inc. is a clinical-stage biotechnology company advancing
the next-generation of oligonucleotide therapies with the goal of
transforming the treatment of severe neuromuscular and neurological
diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO,
platform is founded on over a decade of research and development
and leverages cell-penetrating peptides to improve the uptake and
activity of conjugated oligonucleotide therapeutics. Using these
EDO peptides, we are generating a pipeline of oligonucleotide
therapeutic candidates that are designed to target the root cause
of serious diseases.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. These statements may be identified by words such
as “aims,” “anticipates,” “believes,” “could,” “estimates,”
“expects,” “forecasts,” “goal,” “intends,” “may,” “plans,”
“possible,” “potential,” “seeks,” “will,” and variations of these
words or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the potential
therapeutic benefits and safety profile of our product candidates,
initiation and timeline of the Phase 1 study of PGN-EDODM1, and the
status of regulatory communications.
Any forward-looking statements in this press release are based
on current expectations, estimates and projections only as of the
date of this release and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to that we may experience delays or fail to
successfully initiate or complete our planned clinical trials for
PGN-EDO51 and PGN-EDODM1; our interpretation of clinical and
preclinical study results may be incorrect; our product candidates
may not be safe and effective; there may be delays in regulatory
review, clearance to proceed or approval by regulatory authorities
with respect to our programs, including clearance to commence
planned clinical studies of our product candidates, including
PGN-EDO51 and PGN-EDODM1; changes in regulatory framework that are
out of our control; and we are dependent on third parties for some
or all aspects of our product manufacturing, research and
preclinical and clinical testing. Additional risks concerning
PepGen’s programs and operations are described in our most recent
annual report on Form 10-K and quarterly report on Form 10-Q that
are filed with the SEC. PepGen explicitly disclaims any obligation
to update any forward-looking statements except to the extent
required by law.
Investor ContactLaurence WattsGilmartin
GroupLaurence@gilmartinir.com
Media ContactSarah SuttonArgot
Partnerspepgen@argotpartners.com
PepGen (NASDAQ:PEPG)
過去 株価チャート
から 4 2024 まで 5 2024
PepGen (NASDAQ:PEPG)
過去 株価チャート
から 5 2023 まで 5 2024