Altimmune公布pemvidutide治疗酒精使用障碍二期RECLAIM积极顶线结果

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Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial
Important secondary endpoints were also met, including two-level reduction in WHO risk drinking levels and zero heavy drinking days, both of which are recognized by the FDA as registrational endpoints
A generally favorable tolerability profile was observed in the trial
Conference call to be held today at
8:00 am ET
GAITHERSBURG, Md.
,
July 28, 2026
(GLOBE NEWSWIRE) --
Altimmune, Inc.
(Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced positive topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days (HDD) versus placebo, with consistent positive results across important secondary endpoints, including the
World Health Organization
(WHO) Risk Drinking Levels (RDL), zero HDD and phosphatidyl ethanol (PEth) levels.  A generally favorable tolerability profile was observed in the trial. The Company plans to request an End-of-Phase 2 meeting with the
U.S. Food and Drug Administration
(FDA) based on the results of the trial.
“We are extremely encouraged by these compelling topline results, which showed a highly significant reduction in heavy drinking days and nearly two-thirds of patients treated with pemvidutide achieving a two-level reduction in their WHO-RDL, a clinically meaningful outcome for these patients,” said
Christophe Arbet-Engels
, M.D., Ph.D., Chief Medical Officer at Altimmune. “These data reflect pemvidutide’s strong and consistent efficacy across important measures of drinking behavior, together with a generally favorable tolerability profile in this difficult-to-treat disorder. Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation.”
Efficacy Data
Endpoint
Placebo
Pemvidutide
Treatment Effect
P-value
Change from baseline in HDD/Week at Week 24 (Primary Endpoint)
-2.75 (LS mean)
-4.20 (LS mean)
-1.45 (LS mean difference)
0.0014
2-level Reduction in WHO-RDL
34.8% (16/46)
64.4% (29/45)
Odds Ratio 3.31
0.0049
Zero HDD in Week 21 through Week 24
17.4% (8/46)
42.2% (19/45)
Odds Ratio 3.84
0.0066
Change from baseline in Percent of Days with Abstinence
20.5% (LS mean)
38.9% (LS mean)
18.4% (LS mean difference)
0.0075
Change from baseline in Serum PEth at Week 24
22.0 (LS mean)
-153.4 (LS mean)
-175.3 (LS mean difference)
<0.0001
Key efficacy results included
:
Statistically significant reduction in the primary endpoint of HDD per week versus placebo (p=0.0014)
Statistically significant results on secondary endpoints, including two that are registrational endpoints
Two-level reduction in WHO Risk Drinking Levels versus placebo (p=0.0049)
Zero heavy drinking days versus placebo (p=0.0066)
Statistically significant change in percent of days with abstinence versus placebo (p=0.0075)
Statistically significant reduction in PEth levels versus placebo (p<0.0001)
Statistically significant reduction in body weight, as measured by a placebo-adjusted difference in change from baseline of 9.1% at 24 weeks (p<0.0001), with no evidence of plateauing
Safety and Tolerability Data
Adverse Event (AE)
Placebo
(N=50)
Pemvidutide 2.4mg
(N=50)
Serious AEs
1 (2%)
2 (4%)
Severe AEs
3 (6%)
6 (12%)
Nausea
12 (24%)
22 (44%)
Vomiting
3 (6%)
9 (18%)
Diarrhea
5 (10%)
10 (20%)
Constipation
3 (6%)
13 (26%)
Treatment discontinuations
11 (22%)
10 (20%)
Study drug-related AEs leading to treatment discontinuation
0 (0%)
5 (10%)*
*2 vomiting, 1 constipation, 1 fatigue, 1 exacerbation of hemorrhoids
Pemvidutide was generally well tolerated in this patient population with high unmet need.
The new, simple two-step titration for the 2.4 mg dose may improve gastrointestinal (GI) tolerability compared to prior pemvidutide titration schemes. The majority of adverse events were mild to moderate in severity. There was one serious adverse event (SAE) (hyponatremia) in the pemvidutide arm that was deemed possibly related to treatment drug by the principal investigator.
“As someone who has dedicated his career to understanding and treating alcohol use disorder, I recognize the significance of these findings, particularly given the current attention on the adverse health impact of heavy drinking. These results provide a consistent picture of treatment benefit on self-reported drinking outcomes, supported by objective PEth biomarker evidence,” said
Henry Kranzler
, M.D.,
Karl E. Rickels Professor
of Psychiatry and Director,
Center for Studies of Addiction
,
University of Pennsylvania Perelman School of Medicine
, and Principal Investigator of the RECLAIM trial. “These data underscore the potential for pemvidutide to address multiple dimensions of alcohol use disorder by supporting abstinence and reducing heavy drinking, findings that build on prior evidence of its activity in the liver.”
“These top-line data strengthen our confidence in pemvidutide's differentiation and its potential to benefit people living with MASH, AUD and ALD, who currently have limited treatment options,” said
Jerry Durso
, Chief Executive Officer and Chairman of the
Board of Altimmune
. “These results represent yet another important milestone for Altimmune as we continue to execute on our goal to bring pemvidutide to patients with serious liver diseases while creating value for shareholders.”
Based on these data, Altimmune plans to request an End-of-Phase 2 (EOP2) meeting with the FDA to discuss the path forward for pemvidutide in AUD. Results from the RECLAIM trial will be submitted for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal.
Conference Call Information
Altimmune will host a conference call and webcast at 8:00 a.m ET today to discuss the RECLAIM topline data. The conference call will be webcast live on Altimmune’s Investor Relations (IR)
website.
Participants who would like to join by phone may register
here
to receive the dial-in numbers and unique pin to access the call. Following the conclusion of the call, the webcast will be available for replay on the IR page of the company’s website.
About RECLAIM
RECLAIM (
NCT06987513
) is a Phase 2 trial evaluating the safety and efficacy of pemvidutide in Alcohol Use Disorder (AUD) patients with BMI >25 kg/m
2
, and is the first Phase 2 multicenter study evaluating a dual glucagon-GLP-1 agonist in AUD to report results. Approximately 100 patients were randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial was the change from baseline in the average number of heavy drinking days (HDD) per week, with secondary endpoints including the proportion of patients achieving a 2-level reduction in World Health Organization (WHO) Risk Drinking Levels (RDL), zero HDD, and absolute change from baseline in average levels of phosphatidylethanol (PEth), an objective serum biomarker of alcohol intake. The 2-level reduction in WHO risk drinking levels and zero HDD are recognized by the FDA as registrational endpoints.
About AUD
Alcohol use disorder (AUD) is a medical condition driven by an impaired ability to stop or control the harmful consumption of alcohol. AUD can also lead to serious health consequences, including liver cirrhosis, cardiovascular disease, and cancer. Additionally, many patients with AUD present with comorbidities including excess fat in the liver and obesity, further amplifying their risk for poor outcomes. The World Health Organization estimates that harmful alcohol consumption is the seventh leadi