Altimmune Says Topline Data From RECLAIM Phase 2 Trial Of Pemvidutide For Alcohol Use Disorder Met Its Primary Endpoint Showing Statistically Significant Reduction In Heavy Drinking Days Vs. Placebo

• 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

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
• 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.
• 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.