Altimmune (ALT), a company developing ALT-801 and other biopharmaceuticals announced today positive data from a prespecified 6-week interim analysis of its ongoing 12-week, Phase 1, placebo-controlled, single and multiple ascending dose trial of ALT-801, an investigational GLP-1/glucagon dual receptor agonist, in healthy overweight and obese volunteers. The study is currently being conducted in Australia under a clinical trial application.
The interim data showed a mean weight loss of 5.4% was achieved by Week 6 with a once weekly ALT-801 dose of 1.8 mg administered subcutaneously (sc) compared to a weight gain of 0.9% in the placebo group (net change from placebo of 6.3%, p < .0001), surpassing the pre-established treatment target of 2% weight loss. All but one subject who received the 1.8 mg sc dose achieved at least 3% weight loss by Week 6.
A lower dose cohort that received a weekly 1.2 mg sc dose achieved a mean weight loss of 1.8% (net change from placebo of 2.7%, p < .05) at the same time point. ALT-801 was well-tolerated without dose titration, with transient nausea rates of 14.3% at the 1.2 mg dose and 22.2% at the 1.8 mg dose, and no reports of vomiting, diarrhea or constipation at either dose. All nausea events at the 1.8 mg dose were mild in severity. Gastrointestinal adverse events have required other GLP-1 based agents to dose titrate over 16 to 20 weeks to maintain adequate tolerability.
The ALT-801 Phase 1 trial is currently progressing through higher dose cohorts, and the Company plans to report the results following 12-weeks of dosing in Q3 2021. Based on these latest results, Altimmune now plans to file a second IND in obesity in Q3 2021 to supplement its ongoing NASH program.