Altimmune Granted Fast Track Designation by FDA for Pemvidutide for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
26 Octobre 2023 - 1:30PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to its clinical program
investigating pemvidutide for the treatment of NASH.
NASH is a serious, potentially life-threatening
condition that is a leading cause of liver failure and liver
transplantation globally. NASH is a growing public health concern,
and there are currently no approved treatments. The Fast Track
designation is designed to facilitate the development and expedite
the review of new drugs intended to treat serious conditions and
address unmet medical needs.
“The FDA’s decision was informed by the results
of Altimmune’s studies including its Phase 1b randomized,
placebo-controlled study of pemvidutide in subjects with
non-alcoholic fatty liver disease (NAFLD), which showed
class-leading relative reductions in liver fat and non-invasive
markers of hepatic inflammation and a favorable safety and
tolerability profile,” said Vipin K. Garg, Ph.D., President and CEO
of Altimmune. “The Fast Track designation reflects Altimmune’s
commitment to patients with NASH and efforts to find safe and
effective treatments for this condition.”
The efficacy and safety of pemvidutide in NASH
are being evaluated in IMPACT, a Phase 2b randomized,
placebo-controlled biopsy-driven trial that is being conducted at
approximately 60 sites in the U.S. Approximately 190 subjects with
and without diabetes are being enrolled. Key efficacy endpoints are
NASH resolution and fibrosis improvement at 24 weeks of treatment,
with subjects followed for an additional 24 weeks to a total of 48
weeks for safety and biomarker responses. In addition to IMPACT,
the efficacy and safety of pemvidutide in obesity is being
evaluated in MOMENTUM, a Phase 2b, randomized, placebo-control
trial that is being conducted at approximately 30 sites in the U.S.
An interim analysis of 160 subjects completing 24 weeks of
treatment was reported in Q1 2023, and full results of 391 subjects
receiving up to 48 weeks of treatment are expected later this
quarter.
About Pemvidutide
Pemvidutide is a novel, investigational,
peptide-based GLP-1/glucagon dual receptor agonist in development
for the treatment of obesity and NASH. Activation of the GLP-1 and
glucagon receptors is believed to mimic the complementary effects
of diet and exercise on weight loss, with GLP-1 suppressing
appetite and glucagon increasing energy expenditure. Glucagon is
also recognized as having direct effects on hepatic fat metabolism,
leading to rapid reductions in levels of liver fat. Pemvidutide
incorporates the EuPort™ domain, a proprietary technology that
increases its serum half-life for weekly dosing while likely
slowing the entry of pemvidutide into the bloodstream, which may
improve its tolerability.
About Altimmune
Altimmune is a clinical-stage biopharmaceutical
company focused on developing innovative next-generation
therapeutics for the treatment of obesity and liver diseases. The
Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon
dual receptor agonist that is being developed for the treatment of
obesity and NASH. In addition, Altimmune is developing HepTcell™,
an immunotherapeutic designed to achieve a functional cure for
chronic hepatitis B. For more information, please visit
www.altimmune.com.
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Forward-Looking Statement
Any statements made in this press release
relating to future financial or business performance, conditions,
plans, prospects, trends, or strategies and other financial and
business matters, including without limitation, the timing of key
milestones for our clinical assets, and the prospects for the
utility of, regulatory approval, commercializing or selling any
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the meaning of the Private Securities Litigation Reform Act of
1995. In addition, when or if used in this press release, the words
“may,” “could,” “should,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “plan,” “predict” and similar expressions and
their variants, as they relate to Altimmune, Inc. may identify
forward-looking statements. The Company cautions that these
forward-looking statements are subject to numerous assumptions,
risks, and uncertainties, which change over time. Important factors
that may cause actual results to differ materially from the results
discussed in the forward looking statements or historical
experience include risks and uncertainties, including risks
relating to: delays in regulatory review, manufacturing and supply
chain interruptions, access to clinical sites, enrollment, adverse
effects on healthcare systems and disruption of the global economy;
the reliability of the results of studies relating to human safety
and possible adverse effects resulting from the administration of
the Company’s product candidates; the Company’s ability to
manufacture clinical trial materials on the timelines anticipated;
and the success of future product advancements, including the
success of future clinical trials. Further information on the
factors and risks that could affect the Company's business,
financial conditions and results of operations are contained in the
Company’s filings with the U.S. Securities and Exchange Commission,
including under the heading “Risk Factors” in the Company’s most
recent annual report on Form 10-K and our other filings with the
SEC, which are available at www.sec.gov.
Investor Contact:Rich
Eisenstadt Chief
Financial Officer
Phone:
240-654-1450 reisenstadt@altimmune.com
Media Contact:Danielle CanteyEvoke CanalePhone:
619-826-4657danielle.cantey@evokegroup.com
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