Altimmune Announces Publication of Clinical Study of Pemvidutide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Journal of Hepatology
25 Luglio 2024 - 1:30PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced the data from its 12-week clinical trial
of pemvidutide, an investigational GLP-1/glucagon dual receptor
agonist, in metabolic dysfunction-associated steatotic liver
disease (MASLD) has been published in the Journal of Hepatology.
“MASLD is estimated to affect 25% of adults
globally, with between 20% and 30% of patients progressing to MASH,
making this an area of great unmet medical need,” said Vipin K.
Garg, Ph.D., President and Chief Executive Officer of Altimmune.
“With nearly all subjects achieving 30% or more reductions in liver
fat content after only 12 weeks of treatment, this study
demonstrates the potential of pemvidutide to achieve class-leading
effects in the treatment of MASH. We look forward to sharing
results from our ongoing biopsy-driven Phase 2b IMPACT trial of
pemvidutide in MASH early next year.”
In the study, 94 subjects with obesity or
overweight and LFC ≥10% were randomized and dosed 1:1:1:1 to
pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered
once-weekly subcutaneously for 12 weeks. The study did not include
diet or exercise interventions. Relative reductions in LFC from
baseline, the study’s primary efficacy endpoint, were up to 68.5%
in subjects receiving pemvidutide compared to 4.4% in subjects
receiving placebo. Responder analyses showed that up to 94.4% of
subjects receiving pemvidutide achieved ≥30% relative reduction in
LFC, an important predictor of MASH resolution and fibrosis
improvement, compared to only 4.2% receiving placebo (p <0.0001
vs. placebo, respectively). Moreover, up to 55.6% of subjects
receiving pemvidutide achieved LFC normalization, defined as an LFC
≤5%, compared to 0% of subjects receiving placebo. Significant
reductions in body weight and established markers of MASH
inflammatory activity, including alanine aminotransferase (ALT) and
corrected T1 (cT1) MRI imaging, were also observed. Pemvidutide was
well-tolerated, with a 2.9% rate of adverse event discontinuations
in subjects receiving pemvidutide, and no severe or serious adverse
events.
“We’re excited to publish the results of this
study that demonstrate pemvidutide’s ability to significantly
reduce liver fat, body weight, and hepatic inflammatory activity,
supporting its potential as a treatment for MASH and obesity,” said
Scott Harris, M.D., Chief Medical Officer of Altimmune. “Unlike
other incretin-based therapies that lack glucagon activity,
pemvidutide has a direct effect on hepatic fat metabolism,
providing a mechanism for potentially more potent reductions in
liver fat than that achieved through weight loss alone. Although
not reported in this publication, the Phase 1 trial was extended
for an additional 12 weeks, which resulted in up to 76.4% relative
reduction in liver fat and further improvement in hepatic
inflammation, and we look forward to the publication of these data
in the near future.”
About PemvidutidePemvidutide is
a novel, investigational, peptide-based GLP-1/glucagon dual
receptor agonist in development for the treatment of obesity and
MASH. 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, which is believed to lead to
rapid reductions in levels of liver fat and serum lipids. In
clinical trials to date, once-weekly pemvidutide has demonstrated
compelling weight loss, robust reductions in triglycerides, LDL
cholesterol, liver fat content and blood pressure. The U.S. FDA has
granted Fast Track designation to pemvidutide for the treatment of
MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity
trial and is being studied in the ongoing IMPACT Phase 2b MASH
trial.
About AltimmuneAltimmune is a
clinical-stage biopharmaceutical company focused on developing
innovative next-generation peptide-based therapeutics. The Company
is developing pemvidutide, a GLP-1/glucagon dual receptor agonist
for the treatment of obesity and MASH. For more information, please
visit www.altimmune.com.
Follow @Altimmune, Inc.
on LinkedInFollow
@AltimmuneInc on Twitter
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
product or drug candidates, are forward-looking statements within
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.
Company Contact:Vipin GargPresident and Chief
Executive OfficerPhone: 240-654-1450ir@altimmune.com
Investor Contacts:Lee RothBurns McClellanPhone:
646-382-3403lroth@burnsmc.com
Julia WeilmanBurns McClellanPhone:
646-732-4443jweilman@burnsmc.com
Media Contact:Danielle CanteyInizio Evoke,
BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com
Grafico Azioni Altimmune (NASDAQ:ALT)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Altimmune (NASDAQ:ALT)
Storico
Da Set 2023 a Set 2024