Altimmune, Inc. (Nasdaq: ALT), a clinical-stage
biopharmaceutical company, today announced positive results from a
12-week, Phase 1 trial of pemvidutide (proposed INN, formerly known
as ALT-801), an investigational glucagon-like peptide-1
(GLP-1)/glucagon dual receptor agonist.
The Phase 1 study was a first-in-human,
randomized, placebo-controlled, single ascending dose (SAD) and
multiple ascending dose (MAD) study in overweight and obese
volunteers performed in Australia under a clinical trial
application. Eligible participants included healthy, non-diabetic
subjects with a minimum body mass index (BMI) of 25 kg/m2.
Thirty-four (34) subjects in the MAD portion of the study were
assigned to receive one of three subcutaneous doses of pemvidutide
(1.2 mg, 1.8 mg and 2.4 mg) or placebo once weekly for 12 weeks
without dose titration. Behavioral and caloric restrictive
interventions were not employed.
At 12 weeks, subjects receiving pemvidutide
achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 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, no discontinuations due to adverse events were
reported.
“The achievement of double-digit weight loss for
subjects in the 1.8 mg arm with predominantly mild side effects
reaffirms our enthusiasm for the potential of pemvidutide to be a
transformational therapy for obesity and NASH,” said Vipin K. Garg,
Ph.D., Chief Executive Officer of Altimmune. “We were able to reach
this level of weight loss rapidly without dose titration, which is
commonly used with other drugs in the GLP-1 class. With the recent
clearance of our NASH IND, we are excited to begin the next phase
of development to continue exploring this new therapy and the
potential it has to positively impact those with obesity and
metabolic disorders.”
“The rapid weight loss and response to
pemvidutide across patients and dose groups highlight the
therapeutic advantage conferred by balanced agonism at the GLP-1
and glucagon receptors,” said Scott Harris, M.D., Chief Medical
Officer of Altimmune. “Given that these weight loss data were
obtained without diet or behavioral modifications, we are excited
to see weight loss reach its full potential during the planned
48-week Phase 2 obesity trial next year.”
Summary of 12-week MAD weight loss
findings
|
Treatment |
1.2mg(n=7) |
1.8mg(n=9) |
2.4mg(n=11) |
Pooled Placebo(n=7) |
Baseline demographics |
Age, years |
mean |
27.7 |
32.0 |
31.4 |
35.3 |
BMI (kg/m2) |
mean |
30.0 |
30.1 |
31.8 |
31.0 |
Results |
Weight loss (kg) |
mean |
-4.7 |
-8.8 |
-8.4 |
-1.5 |
Weight loss (%) |
mean |
-4.9% |
-10.3%** |
-9.0%* |
-1.6% |
*p < .01, **p< .005, compared to
placebo
The 1.8 mg dose cohort experienced the highest
weight loss, with 100% of subjects losing at least 5% of body
weight and 55% of subjects losing at least 10% of their body
weight. The amounts of weight loss at the 1.8 and 2.4 mg doses were
essentially the same given the sample size and overlapping
confidence intervals. No correlation was found between the
magnitude of weight loss and either age or baseline BMI.
Favorable trends were observed in secondary
measures, including reductions in systolic and diastolic blood
pressure, serum lipids, and HOMA-IR (a measure of insulin
resistance). In addition, a rise in ketone bodies was observed,
consistent with the effects of glucagon on fat metabolism.
Summary of 12-week MAD safety
findings
Characteristic |
Treatment |
1.2mg(n=7) |
1.8mg(n=9) |
2.4mg(n=11) |
Pooled Placebo(n=7) |
Discontinuations due to adverse events (n) |
0 |
0 |
0 |
0 |
Early withdrawal (n) |
1 |
0 |
2 |
2 |
Nausea |
Mild |
14.3% |
55.6% |
45.5% |
14.3% |
Moderate |
14.3% |
11.1% |
45.5% |
0% |
Vomiting |
Mild |
14.3% |
11.1% |
45.5% |
14.3% |
Moderate |
0% |
11.1% |
27.3% |
0% |
Diarrhea |
Mild |
0% |
0% |
18.2% |
0% |
Moderate |
0% |
0% |
0% |
0% |
Constipation |
Mild |
0% |
11.1% |
18.2% |
0% |
Moderate |
0% |
11.1% |
9.1% |
0% |
Other adverse events (n) |
0 |
2 |
1 |
0 |
Even without dose titration, the symptoms
experienced by subjects who received pemvidutide 1.8 mg were
predominantly mild, did not need treatment and were consistent with
known effects of GLP-1 therapies. Further, tolerability decreased
with higher dose levels. There were no hyperglycemia adverse events
and no increases in the mean heart rate were observed at 6 and 12
weeks of therapy. One patient experienced elevated ALT levels that
resolved rapidly after a pause in dosing.
Pemvidutide development
plan
An Investigational New Drug (IND) application in
non-alcoholic steatohepatitis (NASH) has cleared the U.S. Food and
Drug Administration (FDA) review and will enable additional
clinical studies beyond the current Phase 1 trial, including a
12-week trial to measure reduction in liver fat content in diabetic
and non-diabetic subjects with non-alcoholic fatty liver disease
(NAFLD), which is expected to commence in the near future. The
Company has commenced a drug-drug interaction trial and also plans
to conduct a trial of glucose control in patients with type 2
diabetes that is anticipated to start in the fourth quarter of this
year. Altimmune also intends to begin a 52-week Phase 2
biopsy-driven NASH trial in H1 2022.
The Company intends to file a second IND
application in obesity in Q4 2021 with plans to initiate a 48-week,
Phase 2 obesity trial in H1 2022.
About Pemvidutide
Pemvidutide (proposed INN, formerly known as
ALT-801) is a novel, investigational, peptide-based dual
GLP-1/glucagon receptor agonist that is designed to treat obesity
and non-alcoholic steatohepatitis (NASH). 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.
Conference Call
InformationAltimmune management will host a conference
call and webcast with a slide presentation beginning at 8:30 am
E.T. 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.
Date: |
|
Tuesday, September 28 |
Time: |
|
8:30 am Eastern Time |
Domestic Dial-in: |
|
(844) 615-6509 |
International Dial-in: |
|
(918) 922-3148 |
Conference ID: |
|
3792068 |
Webcast: |
|
https://edge.media-server.com/mmc/p/ojyxaxpp |
About AltimmuneAltimmune 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, 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 initiation of the 12-week NAFLD clinical trial in the
near future, the initiation of the Type 2 diabetes trial in Q4
2021, the initiation of a 52-week NASH clinical trial in H1 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 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
Contact:
Will BrownChief Financial Officer Phone:
240-654-1450wbrown@altimmune.com
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