Altimmune Presents Data at EASL International Liver Congress™ 2024 Supporting the Disease Modifying Potential and Differentiated Therapeutic Profile of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH)
05 Giugno 2024 - 1:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage
biopharmaceutical company, today presented new data on the
potential anti-inflammatory and anti-fibrotic properties of
pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis
(MASH) at the EASL International Liver Congress™ 2024
in Milan, Italy.
“These data, coupled with MOMENTUM Phase 2
obesity trial results that showed class-leading lean mass
preservation in body composition, further reinforce the opportunity
for pemvidutide to distinguish itself broadly from approved
therapies and other clinical candidates targeting MASH and
obesity,” said Vipin K. Garg, Ph.D., President and Chief
Executive Officer of Altimmune. “The balanced GLP-1 and glucagon
dual agonism of pemvidutide represents a potentially differentiated
approach to achieving clinically meaningful reductions in body
weight, liver fat, and lipids to ameliorate MASH and address the
many MASH-associated co-morbidities.”
The data presented are summarized below:
WED-212 (Abstract #3002):
Pemvidutide treatment is associated with improvement in
non-invasive tests indicating greater likelihood of histologic
response in subjects with metabolic dysfunction-associated
steatotic liver disease: a 24-week, randomized, double-blind,
placebo-controlled trial
- 64 subjects who participated in the
Phase 1 study of pemvidutide in MASLD were evaluated for changes in
FibroScan®-AST (FAST) over 24 weeks of treatment. A subset of
subjects with baseline ALT ≥ 30 IU/L were also evaluated for
changes in MRI-PDFF and ALT scores.
- Up to 75% of subjects with
intermediate-to-high risk of MASH progression (FAST ≥ 0.35) at
baseline who received pemvidutide had their risk reduced to low
(FAST < 0.35) at Week 24 vs 25% in subjects receiving
placebo.
- Up to 60% of subjects achieved a
reduction of both MRI-PDFF (≥ 30%) and ALT (≥ 17 IU/L) at Week 24
compared with 0% in subjects receiving placebo. Simultaneous
reductions in MRI-PDFF and ALT have been shown in other MASH
clinical trials to be associated with a significantly greater
likelihood of achieving MASH resolution.
WED-219 (Abstract #2881):
Pemvidutide, a glucagon-like peptide 1/glucagon dual receptor
agonist, improves metabolic dysfunction-associated steatohepatitis
activity and fibrosis in a clinical quantitative systems
pharmacology model
- A quantitative systems pharmacology (QSP) computational model
was used to predict the effects of pemvidutide and the relative
contributions of GLP-1 and glucagon receptor agonism on MASH
outcomes. Data from a completed clinical trial of pemvidutide in
metabolic dysfunction-associated steatotic liver disease (MASLD)
subjects were used to calibrate the quantitative effects of
pemvidutide 1.8 mg once weekly dosing over 24 weeks.
- A strong correlation was observed between clinically reported
and QSP predicted effects of pemvidutide on weight loss and liver
fat content.
- The QSP model predicted pemvidutide 1.8 mg would result in
complete resolution of MASH and a 1-point median improvement in
fibrosis by Week 24.
- Adding glucagon receptor agonism to GLP-1 receptor agonism was
also predicted to result in additional reductions in liver fat
content and median NAFLD activity score (NAS) compared to GLP-1
receptor agonism alone. GLP-1 receptor monotherapy was predicted to
have no effect on fibrosis within the 24-week timeframe.
- Taken together, these results suggest that glucagon receptor
agonism could have potent effects on MASH fibrosis, over and above
GLP-1 monotherapy.
WED-251 (Abstract #2985):
Plasma lipidomic profiling of subjects with overweight or obesity
following treatment with the glucagon-like peptide 1/glucagon dual
receptor agonist pemvidutide: an investigation of lipid signatures
associated with metabolic dysfunction-associated
steatohepatitis
- Plasma lipidomic profiling was
performed on samples collected during Phase 1 studies of
pemvidutide in subjects with overweight or obesity, with or without
MASLD.
- Subjects treated with pemvidutide
had significantly decreased serum lipids from baseline, including
glycophospholipids, sphingolipids and other inflammatory lipid
subspecies associated with MASH and cardiovascular disease.
- Pemvidutide treatment was also
associated with reduced bile acid dysregulation. Obesity and
insulin resistance, two key risk factors for MASH and MASLD,
contribute to bile acid dysregulation. Evidence has shown that bile
acid dysregulation worsens as MASLD progresses.
- These findings support the disease
modifying potential of pemvidutide on MASH and MASH-associated
co-morbidities, including cardiovascular disease.
The posters presented at the EASL International
Liver Congress™ 2024 are accessible on the Events section of the
Altimmune website.
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.
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Company Contact:Richard
EisenstadtChief Financial 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:
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