Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced results from a prespecified 6-week interim
analysis of its ongoing 12-week, Phase 1, placebo-controlled,
single and multiple ascending dose trial of ALT-801, an
investigational GLP-1/glucagon dual receptor agonist, in healthy
overweight and obese volunteers. The study is currently being
conducted in Australia under a clinical trial application.
The interim data showed a mean weight loss of
5.4% was achieved by Week 6 with a once weekly ALT-801 dose of 1.8
mg administered subcutaneously (sc) compared to a weight gain of
0.9% in the placebo group (net change from placebo of 6.3%, p <
.0001), surpassing the pre-established treatment target of 2%
weight loss. All but one subject who received the 1.8 mg sc dose
achieved at least 3% weight loss by Week 6. A lower dose cohort
that received a weekly 1.2 mg sc dose achieved a mean weight loss
of 1.8% (net change from placebo of 2.7%, p < .05) at the same
time point. ALT-801 was well-tolerated without dose titration, with
transient nausea rates of 14.3% at the 1.2 mg dose and 22.2% at the
1.8 mg dose, and no reports of vomiting, diarrhea or constipation
at either dose. All nausea events at the 1.8 mg dose were mild in
severity. Gastrointestinal adverse events have required other GLP-1
based agents to dose titrate over 16 to 20 weeks to maintain
adequate tolerability.
“These data are encouraging considering that
only a 2% weight loss was targeted at 6 weeks of treatment and that
nausea rates were low, without emesis, which is particularly
notable in the absence of dose titration,” commented Stephen
Harrison, MD, Visiting Professor of Hepatology, University of
Oxford, and Medical Director, Pinnacle Research. “The high degree
of weight loss, the very good safety and tolerability profile, and
the absence of dose titration with short treatment duration is very
favorable for ALT-801 and makes it an attractive candidate among
the GLP-1 class of drugs. Based on the relationship between weight
loss and liver fat reduction, and NASH resolution observed in other
studies, ALT-801 appears to be a promising therapeutic candidate
for both obesity and NASH.”
Because the recruited study population was young
(mean age 29.8 years) and non-diabetic, the proportion of subjects
with MRI-PDFF greater than 10% was insufficient to perform an
analysis of liver fat reduction in this population. Consequently,
the Company plans to expand the enrollment criteria and conduct a
separate 12-week Phase 1b study of diabetic and non-diabetic
subjects with non-alcoholic fatty liver disease (NAFLD) in the
United States, which is anticipated to commence in Q3 2021, and to
initiate a 52-week biopsy-driven NASH trial in Q1 2022. The
expansion of enrollment criteria to diabetic and older subjects
will accelerate the recruitment of the target NAFLD population and
mirror the anticipated study population in the 52-week trial.
The ALT-801 Phase 1 trial is currently
progressing through higher dose cohorts, and the Company plans to
report the results following 12-weeks of dosing in Q3 2021. Based
on these latest results, Altimmune now plans to file a second IND
in obesity in Q3 2021 to supplement its ongoing NASH program.
“We are very excited about the potential for
ALT-801 in the expanding GLP-1 therapeutics marketplace,” said
Vipin K. Garg, Ph.D., President and Chief Executive Officer of
Altimmune. “We know that weight loss is strongly correlated with
NASH resolution and that the obesity epidemic in developed nations
has led to an unacceptable increase in chronic illnesses. Assuming
ALT-801 is shown to improve upon the metabolic control and side
effect profile of existing GLP-1 therapies, we believe that ALT-801
could enable more patients to benefit from this type of
treatment.”
About the ALT-801 Phase 1
Trial
The ALT-801 Phase 1 clinical trial is a
placebo-controlled, first-in-human, single ascending dose (SAD) and
multiple ascending dose (MAD) study in overweight and obese
volunteers being conducted in Australia under a clinical trial
application. Study subjects did not participate in behavioral
weight loss programs or undergo caloric restriction. The primary
objectives of the trial are to assess the safety and tolerability,
pharmacokinetics, and weight loss in ALT-801 recipients compared to
placebo over 12 weeks of weekly dosing. Reduction in liver fat
content will be assessed in a separate 12-week Phase 1b trial of
diabetic and non-diabetic subjects with NAFLD anticipated to
commence in Q3 2021. Dosing in the MAD phase commenced with a
cohort receiving ALT-801 1.2 mg sc or placebo once weekly and is
progressing through higher dose cohorts. Subjects in the 1.2 mg and
1.8 mg cohorts currently have completed 6 weeks of treatment.
Interim analyses at 6 weeks of dosing have been performed for the
first two study cohorts, and the results of 12 weeks of dosing in
these and additional cohorts are expected to be announced in Q3
2021.
Conference Call Information |
|
|
Date: |
Wednesday, June 16, 2021 |
Time: |
8:30 am Eastern Time |
Domestic Dial-in: |
877-423-9813 |
International Dial-in: |
201-689-8573 |
Conference ID: |
13720570 |
Webcast: |
http://public.viavid.com/index.php?id=145274 |
Following the conclusion of the call, the
webcast will be available for replay on the Investor Relations page
of the Company’s website at www.altimmune.com. The company has
used, and intends to continue to use, the IR portion of its website
as a means of disclosing material non-public information and for
complying with disclosure obligations under Regulation FD.
About ALT-801
ALT-801 is a novel, investigational,
peptide-based dual GLP-1/glucagon receptor agonist that is designed
to treat the obesity and metabolic dysfunction that causes NASH. As
the most severe form of non-alcoholic fatty liver disease, or
NAFLD, NASH involves multiple metabolic pathways leading to the
abnormal accumulation of liver fat, toxic lipid metabolites, and
inflammation, resulting ultimately in fibrosis (cirrhosis) or liver
cancer. Altimmune believes the treatment of obesity is the
cornerstone of treating NASH and the principal morbidities of NASH.
Glucagon increases energy expenditure and adipose tissue browning
and works synergistically with GLP-1 to facilitate greater degrees
of weight loss than GLP-1 alone. As observed in a well-established
preclinical model of the disease, ALT-801 induced significantly
greater weight loss compared to semaglutide, a GLP-1 receptor
agonist, along with significantly greater decreases in liver fat,
plasma ALT, and other markers of NASH. The pharmacokinetic profile
of ALT-801 may provide for once weekly administration without
dose-titration and may have a low incidence of GI side effects,
attributes that we believe could improve patient compliance and
reduce treatment discontinuation.
About Altimmune
Altimmune is a clinical stage biopharmaceutical
company focused on developing intranasal vaccines, immune
modulating therapies and treatments for liver disease. Our diverse
pipeline includes proprietary intranasal vaccines for COVID-19
(AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an
intranasal immune modulating therapeutic for COVID-19 (T-COVID™);
and next generation peptide therapeutics for NASH (ALT-801) and
chronic hepatitis B (HepTcell™). For more information on Altimmune,
please visit www.altimmune.com.
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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, the timing of the 12-week data
readout from the ALT-801 Phase 1 clinical trial in Q3 2021, the
timing of the filing of IND applications, the potential to initiate
a 12 week NAFLD trial in Q3 2021, the timing of the filing of an
additional IND and initiate an obesity program in 2021, the
potential therapeutic effects of ALT-801, the prospects for
regulatory approval, our ability to manufacture ALT-801 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 Contacts: |
|
|
|
Will Brown |
Stacey Jurchison |
Chief Financial Officer |
Sr. Dir, Investor Relations |
Phone: 240-654-1450 |
Phone: 410-474-8200 |
wbrown@altimmune.com |
sjurchison@altimmune.com |
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