Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company (the “Company”), today announced topline results from its
48-week MOMENTUM Phase 2 obesity trial of pemvidutide. The trial
enrolled 391 subjects with obesity or overweight with at least one
co-morbidity and without diabetes. Subjects were randomized 1:1:1:1
to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered
weekly for 48 weeks in conjunction with diet and exercise. The 1.2
mg and 1.8 mg doses were administered without dose titration, while
a short 4-week titration period was employed for the 2.4 mg dose.
At baseline, subjects had a mean age of approximately 50 years,
mean body mass index (BMI) of approximately 37 kg/m2 and mean body
weight of approximately 104 kg. Approximately 75% of subjects were
female.
At Week 48, subjects receiving pemvidutide
achieved mean weight losses of 10.3%, 11.2%, 15.6% and 2.2% at the
1.2 mg, 1.8 mg, and 2.4 mg doses and placebo, respectively, with a
near-linear trajectory of continued weight loss observed on the 2.4
mg dose at the end of treatment. Over 50% of subjects achieved at
least 15% weight loss and over 30% of subjects achieved at least
20% weight loss on the 2.4 mg dose. As in prior clinical trials,
pemvidutide resulted in robust reductions in serum lipids and
improvements in blood pressure without imbalances in cardiac
events, arrhythmias or clinically meaningful increases in heart
rate. Glucose homeostasis was maintained, with no significant
changes in fasting glucose or HbA1c.
More subjects receiving pemvidutide stayed on
study compared to those receiving placebo, with 74.1% of
pemvidutide subjects completing the trial compared to 61.9% of
placebo subjects. Nausea and vomiting comprised the majority of
adverse events (AEs) and were predominantly mild to moderate in
severity. Only one (1.0%) subject experienced a drug-related
serious adverse event (SAE), a case of vomiting at the 2.4 mg dose.
Rates of AEs leading to treatment discontinuation were 6.2% in
subjects receiving placebo and 5.1%, 19.2%, and 19.6% in subjects
receiving 1.2 mg, 1.8 mg and 2.4 mg of pemvidutide, respectively.
Study discontinuations related to study drug occurred in 2.1% of
placebo subjects and 4.1%, 16.2% and 15.5% in subjects receiving
1.2 mg, 1.8 mg and 2.4 mg of pemvidutide, respectively, with most
discontinuations due to AEs in the pemvidutide groups occurring in
the first 16 weeks of treatment. No AEs of special interest or
major adverse cardiac events (MACE) were observed, and there were
low rates of cardiac AEs, including arrhythmias, with no imbalance
across pemvidutide or placebo groups.
“The level of weight loss achieved at 48 weeks
in this trial has been shown to reverse the key complications of
obesity. Moreover, the trajectory of weight loss at the end of
treatment with the 2.4 mg dose suggests the potential for greater
weight loss with continued treatment,” said Dr. Scott Harris, Chief
Medical Officer of Altimmune. Dr. Harris added, “It is also
important to recognize the safety profile of pemvidutide observed
to date, especially cardiac-related safety, considering that many
obesity patients are at risk for cardiovascular events such as
arrhythmias and major adverse cardiac events.”
“This is an important day for Altimmune and we
couldn’t be more pleased with these results,” said Vipin K. Garg,
Ph.D., President and Chief Executive Officer of Altimmune. “To put
these results in context, the 15.6% mean weight loss observed with
the 2.4 mg dose was associated with a mean weight loss of 32.2 lbs
at 48 weeks. The impact of this level of weight loss on patients
can be significant. For example, 48% of subjects on the 2.4 mg dose
with baseline obesity no longer had obesity at the end of the
48-week trial.” Dr. Garg continued, “We believe the magnitude of
weight loss, robust reductions in triglycerides, LDL cholesterol
and blood pressure, together with the safety profile observed in
this trial, could potentially differentiate pemvidutide from the
other incretin-based therapies. If approved, we believe pemvidutide
could offer an important option for obesity patients, including
those with risk factors for cardiovascular disease.”
Summary of Efficacy
Findings
Primary Endpoint: Body weight |
Placebo(N=97) |
1.2 mg(N=98) |
1.8 mg(N=99) |
2.4 mg(N=97) |
∆ Bodyweight, all subjects |
%, LSM (SE)1 |
-2.2 (1.4) |
-10.3 (1.4)*** |
-11.2 (1.4)*** |
-15.6 (1.4)*** |
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Responder Analyses |
Placebo(N=51) |
1.2 mg(N=70) |
1.8 mg(N=63) |
2.4 mg(N=56) |
% Subjects w/ ≥5% weight loss |
%2 |
17.6% |
68.6%**** |
76.2%**** |
83.9%**** |
% Subjects w/ ≥10% weight loss |
3.9% |
42.9%**** |
49.2%**** |
71.4%**** |
% Subjects w/ ≥15% weight loss |
2.0% |
21.4%** |
28.6%*** |
51.8%**** |
% Subjects w/ ≥20% weight loss |
2.0% |
10.0% |
9.5% |
32.1%**** |
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Secondary Endpoints |
Placebo(N=50) |
1.2 mg(N=69) |
1.8 mg(N=58) |
2.4 mg(N=55) |
∆ Total cholesterol |
%, LSM (SE)3 |
-2.8 (2.0) |
-11.6 (1.7)** |
-13.1 (1.9)*** |
-15.1 (2.0)*** |
∆ LDL cholesterol |
-2.8 (4.1) |
-6.2 (3.5) |
-11.2 (3.8) |
-9.9 (3.9) |
∆ Triglycerides |
+7.3 (4.6) |
-21.7 (3.9)*** |
-22.3 (4.3)*** |
-34.9 (4.4)*** |
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Blood Pressure and Heart Rate |
Placebo(N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
∆ Systolic BP |
mm Hg,LSM (SE)1 |
+3.5 (2.3) |
-2.3 (2.2) |
-1.6 (2.2) |
-4.6 (2.3) |
∆ Diastolic BP |
+1.8 (1.4) |
-2.1 (1.3) |
-1.0 (1.3) |
-2.9 (1.4) |
∆ Heart rate |
bpm, LSM (SE)1 |
-1.4 (1.6) |
0.1 (1.5) |
3.1 (1.5) |
2.5 (1.6) |
1 MMRM (mixed model for repeated measures), 2 CMH (Cochran
Mantel Haenszel), 3 ANCOVA (analysis of covariance)
*p < 0.05; ** p < 0.005, *** p < 0.001, ****p <
0.0001 compared with placebo
Summary of Safety and
Tolerability
Adverse events (AEs) |
Placebo(N=97) |
1.2 mg (N=98) |
1.8 mg(N=99) |
2.4 mg(N=97) |
SAEs related to study drug |
N (%) |
0 (0.0%) |
0 (0.0%) |
0 (0.0%) |
1 (1.0%)4 |
All AEs leading to discontinuation |
N (%) |
6 (6.2%) |
5 (5.1%) |
19 (19.2%) |
19 (19.6%) |
Drug-related AEs leading to discontinuation |
N (%) |
2 (2.1%) |
4 (4.1%) |
16 (16.2%) |
15 (15.5%) |
Gastrointestinal AEs—mainly mild to moderate |
Nausea |
N (%) |
11 (11.3%) |
25 (25.5%) |
59 (59.6%) |
50 (51.5%) |
Vomiting |
N (%) |
3 (3.1%) |
6 (6.1%) |
27 (27.3%) |
27 (27.8%) |
Diarrhea |
N (%) |
5 (5.2%) |
8 (8.2%) |
10 (10.1%) |
18 (18.6%) |
Constipation |
N (%) |
8 (8.2%) |
17 (17.3%) |
13 (13.1%) |
22 (22.7%) |
Major Adverse Cardiac Events (MACE) |
N (%) |
0 (0.0%) |
0 (0.0%) |
0 (0.0%) |
0 (0.0%) |
Cardiac AEs including arrhythmias |
N (%) |
4 (4.1%) |
3 (3.1%) |
4 (4.0%) |
3 (3.1%) |
4 Vomiting
Summary of Glycemic
Control |
Placebo(N=50) |
1.2 mg (N=68) |
1.8 mg(N=58) |
2.4 mg(N=55) |
Fasting glucose |
Baseline, mg/dL |
mean (SE) |
95.5 (1.5) |
99.4 (1.4) |
101.6 (1.4) |
101.5 (1.6) |
Week 48, mg/dL |
mean (SE) |
95.2 (1.5) |
98.6 (1.7) |
100.6 (1.6) |
99.4 (2.0) |
HbA1c |
Baseline, % |
mean (SE) |
5.6 (0.0) |
5.5 (0.0) |
5.5 (0.1) |
5.6 (0.0) |
Week 48, % |
mean (SE) |
5.5 (0.0) |
5.5 (0.0) |
5.6 (0.1) |
5.5 (0.1) |
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About PemvidutidePemvidutide is
a novel, investigational, peptide-based GLP-1/glucagon dual
receptor agonist in development for the treatment of obesity and
metabolic dysfunction-associated steatohepatitis (MASH), formerly
known as non-alcoholic steatohepatitis (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 EuPortTM 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.
Conference Call
InformationAltimmune management will host a conference
call and webcast with a slide presentation presented by Dr. Scott
Harris, Chief Medical Officer beginning at 8:30 am E.T. tomorrow.
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.
Conference Call Details: |
Date: |
Friday,
December 1 |
Time: |
8:30 am Eastern Time |
Webcast: |
To listen, the conference call will be webcast live on
Altimmune’s Investor Relations website at
https://ir.altimmune.com/investors. |
Dial-in: |
To participate or dial-in, register here to receive the dial-in
numbers and unique PIN to access the call. |
|
|
About AltimmuneAltimmune is a
clinical-stage biopharmaceutical company focused on developing
treatments for 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
MASH, formerly known as NASH. In addition, Altimmune is developing
HepTcell™, an immunotherapeutic designed to achieve a functional
cure for chronic hepatitis B. 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 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
(the “SEC”), including under the heading “Risk Factors” in the
Company’s most recent annual report on Form 10-K and its other
filings with the SEC, which are available at www.sec.gov.
Investor Contact:Rich EisenstadtChief Financial
OfficerPhone: 240-654-1450reisenstadt@altimmune.com
Media Contact: Danielle Duchene Evoke Canale
Phone: 619-826-4878Danielle.Duchene@canalecomm.com
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