Altimmune, Inc. ALT, a clinical-stage company, announced positive top-line results from the 48-week phase II MOMENTUM study of its obesity drug candidate, pemvidutide.
ALT’s pemvidutide is a novel, investigational and peptide-based GLP-1/glucagon dual receptor agonist, which is currently under mid-stage development to treat obesity and metabolic dysfunction-associated steatohepatitis, formerly known as non-alcoholic steatohepatitis. GLP-1 obesity drugs are designed to suppress appetite so an individual eats less and eventually loses weight.
The obesity market has garnered much interest lately, ever since Novo Nordisk NVO received FDA approval for Wegovy (semaglutide 2.4 mg). The FDA approved Wegovy in 2021 for chronic weight management in adults with obesity or overweight. The vested interest of drug manufacturers in the obesity indication is due to the huge untapped market opportunity that it represents amid increasing demand.
Altimmune’s stock surged 82.6% in the last trading session as investors cheered the success of the mid-stage study of its investigational obesity drug, pemvidutide. The stock also jumped 3.4% in the after hours on Dec 1, 2023. Year to date, shares of ALT have lost 78.3% compared with the industry’s 9.6% decline.
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The phase II MOMENTUM study enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes. The total patient population was then randomized equally into four cohorts to receive either a dose of pemvidutide (1.2 mg, 1.8 mg or 2.4 mg) or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
The enrolled patients were approximately 50 years of age, having a mean body mass index (BMI) of approximately 37 kg/m2 and a mean body weight of approximately 104 kg. Around 75% of the patients were female.
Per the data readout at week 48, patients treated with the1.2 mg, 1.8 mg and 2.4 mg doses of pemvidutide in the MOMENTUM study achieved mean weight losses of 10.3%, 11.2% and 15.6%, respectively, while patients treated with placebo achieved a mean weight loss of 2.2%. Altimmune reported that the patients in the 2.4 mg pemvidutide dose cohort observed a near-linear trajectory of continued weight loss at the end of the treatment.
The company also provided additional statistics regarding the study results. It was observed that in the 2.4 mg cohort, more than 50% of patients achieved at least 15% weight loss and over 30% of subjects achieved at least 20% weight loss.
Consistent with results observed in previous studies of pemvidutide, it was also observed that the drug led to superior reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias, or clinically meaningful increases in heart rate.
Furthermore, Altimmune also witnessed that more patients (74.1%) are completing treatment with pemvidutide compared with the placebo subjects (61.9%). Adverse events were mostly mild-moderate in severity. The most common adverse events were nausea and vomiting.
Altimmune, Inc. Price and Consensus
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Currently, Novo Nordisk is the leader in the Diabetes and Obesity Care market, with one of the broadest GLP-1 portfolios in the industry. Wegovy is seeing strong prescription trends and is generating impressive revenues and profits for NVO.
However, the Danish pharma giant has been facing serious supply constraints for Wegovy in the international markets as demand for the drug skyrocketed. To tackle the supply issue, last month, Novo Nordisk announced that it is set to invest more than 16 billion Danish kroner (€2.1 billion) by the end of 2023 to expand the existing production site in Chartres, France, for the current and future product portfolio within serious chronic diseases.
Other large-cap drug makers are also currently operating in the obesity care market, like Eli Lilly LLY and Pfizer PFE. Last month, Lilly received FDA approval for tirzepatide, under the brand name Zepbound, for chronic weight management in adults with obesity or overweight. Lilly’s tirzepatide was approved by the FDA in 2022 under the trade name Mounjaro, a dual GIP and GLP-1 receptor agonist, to treat adults with type 2 diabetes mellitus.
Since its launch, Mounjaro has shown an impressive initial uptake. Approval of the obesity indication is expected to help Lilly rake in billions of dollars from tirzepatide sales.
Pfizer recently faced a setback after announcing its decision to not move forward with phase III studies on its twice-daily weight loss pill, danuglipron, due to side effects seen in a phase IIb study. Although Pfizer’s phase IIb study met its primary endpoint of change in body weight from baseline with statistical significance, high rates of gastrointestinal side effects were observed in the study which included nausea, vomiting and diarrhea.
Pfizer also observed a significantly higher discontinuation rate among patients treated with danuglipron (greater than 50%, seen across all doses) compared with those treated with placebo (40%).
The failure of the phase IIb study on danuglipron is a significant blow to PFE’s efforts to take a share of the growing market of GLP-1 drugs for treating obesity.
Altimmune currently has a Zacks Rank #3 (Hold).
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