Altimmune Announces Initiation of Phase 2b IMPACT Trial Evaluating the Efficacy and Safety of Pemvidutide in Non-Alcoholic Steatohepatitis (NASH)
01 Agosto 2023 - 8:30AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that it has enrolled the first subject in
the Phase 2b IMPACT trial evaluating the efficacy and safety of
pemvidutide in subjects with non-alcoholic steatohepatitis (NASH).
Pemvidutide is a novel, investigational GLP-1/glucagon dual
receptor agonist under development for the treatment of obesity and
NASH.
This randomized, placebo-controlled
biopsy-driven trial is being conducted at approximately 60 sites in
the United States, with Dr. Stephen Harrison, Medical Director,
Pinnacle Research, and Adjunct Professor of Medicine, Oxford
University, serving as the Principal Investigator. The trial is
expected to enroll approximately 190 subjects with and without
diabetes randomized 1:2:2 to receive either 1.2 mg, 1.8 mg
pemvidutide or placebo weekly for 48 weeks. The 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. Top-line
results are expected in Q1 2025.
Results from a blinded, 24-week Phase 1b trial
of pemvidutide in subjects with non-alcoholic fatty liver disease
(NAFLD) showed a greater than 75% relative reduction in liver fat
and 19% relative reduction in liver volume, with over 50% of the
subjects achieving normalization of liver fat at the 1.8 mg dose.
In addition, significant reductions in serum alanine
aminotransferase (ALT) and MRI-based corrected T1 (cT1) were
observed, both established markers of liver inflammation. Glycemic
control was maintained, with trends toward improvements in fasting
glucose and HbA1c in subjects with diabetes. Subjects on 1.8 mg
pemvidutide also achieved a mean weight loss of 6.2%, with
continuing weight loss at the end of treatment. Preclinical studies
have shown pemvidutide to have anti-fibrotic effects in animal
studies.
“Initiation of the IMPACT Phase 2b trial
represents an important milestone in the development of pemvidutide
for NASH,” said Scott Harris, M.D., Chief Medical Officer of
Altimmune. “We are encouraged by the robust reductions of liver
fat, inflammatory markers, serum lipids and body weight in our
Phase 1b trial and anti-fibrotic effects in preclinical studies of
pemvidutide and are excited about the prospect of achieving
impressive rates of NASH resolution and fibrosis improvement in our
IMPACT trial.”
About PemvidutidePemvidutide 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 EuPortTM 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 AltimmuneAltimmune is a
clinical-stage biopharmaceutical company focused on developing
innovative next-generation therapeutics for the treatment of
patients with liver diseases and obesity. 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 StatementAny
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, the timing of the data readout of the Phase 2b IMPACT trial
of pemvidutide in NASH 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.
Altimmune Investor & Media
Contact:
Rich EisenstadtChief Financial Officer Phone:
240-654-1450reisenstadt@altimmune.com
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