Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that it has enrolled the first patient in
a Phase 1b clinical trial of pemvidutide (proposed INN, formerly
known as ALT-801) in subjects with non-alcoholic fatty liver
disease (NAFLD). Pemvidutide is a novel, investigational
GLP-1/glucagon dual receptor agonist under development for the
treatment of obesity and non-alcoholic steatohepatitis (NASH), the
most severe form of NAFLD.
The trial is being conducted at multiple sites
in the United States with Dr. Stephen Harrison, a renowned expert
in the field of NASH and liver diseases, serving as the Principal
Investigator. This double-blind, randomized, placebo-controlled
study will enroll approximately 72 diabetic and non-diabetic
overweight and obese adult patients with a liver fat content
greater than 10% as measured by MRI-PDFF. Pemvidutide will be
administered weekly at one of three dose levels versus placebo over
12 weeks. The primary efficacy endpoint is change in liver fat
content from baseline, as measured by MRI-PDFF. Secondary efficacy
endpoints include weight loss, serum lipid profile, hemoglobin A1c,
adiponectin, and inflammatory and fibrosis markers. The study is
expected to read out topline results in the first half of 2022.
Based on the findings of the NAFLD study, the Company intends to
initiate a 52-week biopsy driven Phase 2 NASH study in 2022.
“We are excited to initiate this NAFLD trial as
we build on our recent clinical trial results in overweight and
obese subjects, where we saw 10.3% weight loss at the 1.8 mg dose
and positive effects on blood pressure, serum lipids and insulin
resistance in only 12-weeks,” said Dr. Scott Harris, Chief Medical
Officer of Altimmune. “Studies show that sustained weight loss
greater than 10% leads to NASH resolution and fibrosis improvement.
Meaningful weight loss, combined with the potent effects of
glucagon agonism on liver fat, as observed in animal models, make a
compelling case for pemvidutide in the treatment of NASH.”
NAFLD is a precursor to NASH, characterized by
the buildup of excess fat in liver cells, usually as a consequence
of obesity. It is estimated that more than 100 million people in
the United States have NAFLD, and it is now the most common form of
liver disease in children. If unaddressed, the condition may
progress to NASH, where the liver is chronically inflamed and
becomes fibrotic, and eventually cirrhosis. The World Hepatitis
Alliance recently reported that NASH is now the most common reason
for a liver transplant in women, older patients and people
receiving Medicare insurance in the United States.
Altimmune believes the treatment of obesity is
the cornerstone of treating NASH and its co-morbidities and views
the treatment of obesity and NASH as significant unmet medical
needs that can be addressed through significant weight loss. In a
12-week Phase 1 study in Australia, subjects receiving pemvidutide
achieved mean weight losses of 4.9%, 10.3%, and 9.0% at 1.2 mg, 1.8
mg, and 2.4 mg doses, respectively, with the placebo group
experiencing a mean weight loss of 1.6%. Weight loss occurred
rapidly and consistently over 12-weeks. Side effects were mild to
moderate, with no serious or severe treatment-emergent adverse
events. Importantly, pemvidutide was well-tolerated without the
need for dose titration, and no discontinuations due to adverse
events were reported.
Pemvidutide development planAn
Investigational New Drug (IND) application in NASH recently cleared
the U.S. Food and Drug Administration (FDA) review, enabling this
12-week Phase 1b trial in subjects with NAFLD. The Company has also
commenced a drug-drug interaction trial in Australia and plans to
initiate a trial of glucose control in patients with type 2
diabetes in the U.S. later this year. Topline data from all three
trials are expected in the first half of 2022.
The Company intends to file a second IND
application in obesity in 2021 with plans to initiate a 48-week,
Phase 2 obesity trial in H1 2022.
About Altimmune
Altimmune is a clinical stage biopharmaceutical
company focused on developing treatments for obesity and liver
diseases. Our pipeline includes next generation peptide
therapeutics for obesity, NASH (pemvidutide), and chronic hepatitis
B (HepTcell™). For more information on Altimmune, please visit
www.altimmune.com.
Follow @Altimmune, Inc. on
LinkedInFollow @AltimmuneInc on
Twitter
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 initiation of the Type 2 diabetes trial in 2021,
12-week study readout of the Phase 1b NAFLD trial in the first half
of 2022, the initiation of a 52-week NASH clinical trial in 2022,
the timing of topline data for the drug-drug interaction trial and
type 2 diabetes trial in the first half of 2022, the timing of the
filing of an additional IND for obesity in Q4 2021, initiation of a
48-week Phase 2 obesity trial in H1 2022, the potential therapeutic
effects of pemvidutide, the prospects for regulatory approval, our
ability to manufacture pemvidutide for our clinical trials and
commercial needs, and 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. (the
“Company”) 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: potential impacts due
to the COVID-19 pandemic such as 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 and commercial supply 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 annual
report on Form 10-K for the fiscal year ended December 31,
2020 filed with the SEC, which is available
at www.sec.gov.
Altimmune Investor & Media
Contact:
Will BrownChief Financial Officer Phone:
240-654-1450wbrown@altimmune.com
Altimmune (NASDAQ:ALT)
Historical Stock Chart
From Apr 2024 to May 2024
Altimmune (NASDAQ:ALT)
Historical Stock Chart
From May 2023 to May 2024