Altimmune Inc. (NASDAQ:ALT) has reported positive topline outcomes from its RECLAIM Phase 2 trial assessing pemvidutide in patients diagnosed with moderate to severe alcohol use disorder (AUD).
The late clinical-stage biopharmaceutical company confirmed that the study successfully met its primary endpoint, showing a statistically significant decrease in heavy drinking days per week compared to placebo.
Efficacy Metrics And Weight Loss Data
The investigational candidate—a balanced glucagon/GLP-1 dual receptor agonist—also achieved statistically significant improvements across major secondary endpoints, including two registrational endpoints.
Results demonstrated a two-level reduction in World Health Organization Risk Drinking Levels, an increased incidence of zero heavy drinking days, a higher percentage of days with total abstinence, and reduced phosphatidyl ethanol (PEth) levels versus placebo.
In addition to alcohol reduction metrics, participants receiving pemvidutide achieved a statistically significant 9.1% placebo-adjusted body weight reduction from baseline at 24 weeks.
The company noted that there was no evidence of body weight loss plateauing after this period.
“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, Chief Medical Officer at Altimmune.
Tolerability Profile And FDA Next Steps
Pemvidutide demonstrated a generally favorable tolerability profile throughout the RECLAIM trial.
A new, simple two-step titration scheme implemented for the 2.4 mg dosage may improve gastrointestinal tolerability compared with earlier pemvidutide titration schedules.
The majority of reported adverse events were mild to moderate in severity.
However, a single serious adverse event involving hyponatremia occurred in the pemvidutide treatment arm, which was deemed possibly related to the treatment drug by the principal investigator.
Based on these positive clinical data, Altimmune intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the clinical and regulatory path forward for pemvidutide in AUD.
ALT Stock Price Activity: Altimmune shares were up 11.15% at $3.29 during premarket trading Tuesday, according to Benzinga Pro data.
Image via Shutterstock/ Axel Bueckert
