Altimmune Inc. (ALT) stock reacts opposite to the Phase 1 Clinical Trial of ALT-801 data announced by the company. In the 12-week trials, the mean weight loss of 10.3% was achieved in subjects receiving a 1.8 mg dose.
The biopharmaceutical firm, Altimmune Inc. (ALT), has just updated its ongoing Phase 1 trial results of pemvidutide (formerly known as ALT-801). The results from the 12-week study shows positive data as pemvidutide was well-tolerated without the need for dose titration.
Surprisingly, ALT stock is significantly down as of trading on September 28, 2021. The share price has dropped over 30% since the last trading day.
Altimmune is currently working on its investigational glucagon-like peptide-1/glucagon dual receptor agonist. The phase 1 study was a first-in-human, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight and obese participants. The study was being conducted in Australia – under a clinical trial application.
The volunteers that were part of the phase 1 trials included healthy, non-diabetic subjects with a minimum BMI of 25 kg/m2. One of three subcutaneous doses of pemvidutide were given to 34 participants in the MAD portion, once every week for 12 weeks in a row.
The outcomes at the end of 12-weeks came out with a mean weight loss of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively. Whereas, the placebo group resulted in a mean weight loss of 1.6%. The participants lost weight quite swiftly and consistently over 12-weeks.
The important aspect of the phase 1 trials was that the side effects were almost little to none. Especially, there were no discontinuations due to adverse events including side mild to moderate side effects.
The CEO of Altimmune, Vipin K. Garg was enthused by these results and said that this double-digit weight loss for subjects in the 1.8 mg arm is a great achievement. He added that the company’s hard work is reflected in the phase 1 trials and shows the potential of pemvidutide to be a transformational therapy for obesity and NASH.
Altimmune is now looking forward to beginning the phase 2 trials of 48-weeks and continue exploring this new therapy. The current data suggest that the response to pemvidutide across patients and dose groups reflects the therapeutic advantage conferred by balanced agonism at the glucagon receptors. The key was that the weight loss was obtained without any diet or behavioral modifications.
In addition, Altimmune Inc. (ALT) has initiated a drug-drug interaction trial. Moreover, the ALT team is focused on starting a trial of glucose control in patients with type 2 diabetes, which is expected at the end of 2021.