Altimmune Announces Completion of Dosing in the Phase 2 MOMENTUM Trial of Pemvidutide in Subjects with Obesity or Overweight
September 12 2023 - 7:30AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced the completion of dosing (last subject
last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the
efficacy and safety of pemvidutide in subjects with obesity or
overweight. Pemvidutide is a novel, investigational GLP-1/glucagon
dual receptor agonist under development for the treatment of
obesity and non-alcoholic steatohepatitis (NASH).
MOMENTUM is a multicenter, randomized,
placebo-controlled trial that is being conducted at approximately
30 sites in the United States, with Dr. Louis J. Aronne, Founder
and Director of the Center for Weight Management at Weill-Cornell
Medical Center, and a leading authority in obesity and obesity
clinical trials, serving as the Principal Investigator. At the
conclusion of enrollment, a total of 391 subjects with obesity or
overweight and without diabetes were enrolled and randomized, the
higher than planned enrollment reflecting the high enthusiasm for
the trial and surge in eligible participants at final screenings.
Subjects were randomized 1:1:1:1 to either 1.2 mg, 1.8 mg, 2.4 mg
pemvidutide or placebo administered weekly for 48 weeks in
conjunction with diet and exercise. The primary endpoint of the
trial is the relative (percent) change in body weight at 48-weeks
compared to baseline, with additional readouts including metabolic
and lipid profiles, cardiovascular measures and glucose
homeostasis.
“We remain on target to announce topline 48-week
results from our Phase 2 MOMENTUM trial in the fourth quarter of
this year,” said Vipin K. Garg, Ph.D., President and CEO of
Altimmune. “We believe pemvidutide offers a highly differentiated
product profile that includes significant reductions in body
weight, serum lipids and liver fat, without increases in heart rate
or other cardiovascular safety signals. We also believe this
combination of attributes has the potential to demonstrate best in
class benefits in future cardiovascular outcome trials.”
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 CHB.
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 readouts of the Phase 2 MOMENTUM
trial of pemvidutide in obesity, 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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