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Altimmune (ALT) Rises 7% on Completing Dosing in Obesity Study
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Altimmune, Inc. (ALT - Free Report) , a clinical-stage company, announced completing the dosing of patients in a phase II study, evaluating the safety and efficacy of lead pipeline candidate, pemvidutide, in patients with obesity or overweight. Pemvidutide is the company’s novel, investigational GLP-1/glucagon dual receptor agonist, which is currently being developed to treat obesity and non-alcoholic steatohepatitis (NASH).
Per the press release, Altimmune’s phase II MOMENTUM study enrolled a total of 391 patients with obesity or overweight and without diabetes. The patients were divided into four cohorts receiving either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
The relative percentage change in body weight at week 48 compared with baseline is the primary endpoint of the MOMENTUM study. Other readouts from the mid-stage study include metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
ALT is on track to announce top-line results from the phase II MOMENTUM study in the fourth quarter of 2023.
The stock of the company rose 7.4% on Tuesday in response to the encouraging news. Year to date, shares of Altimmune have nosedived 84.1% compared with the industry’s 4.1% fall.
Image Source: Zacks Investment Research
We would like to remind the investors that in March 2023, Altimmune announced positive top-line results from its interim analysisof the MOMENTUM phase II obesity study on pemvidutide. The interim analysis data was from 160 subjects who completed 24 weeks of treatment.
However, a treatment discontinuation rate of 28.2% in subjects receiving the placebo and 24% in subjects receiving pemvidutide was observed in the first 16 weeks of treatment. Discontinuation of treatment with pemvidutide was mostly due to the adverse events observed. This did not impress investors leading to a massive drop in the stock price at the time.
Besides the obesity/overweight indication, Altimmune is also currently developing pemvidutide to treat NASH in a mid-stage study. Its pipeline also includes another candidate, HepTcell, a novel, investigational and immunotherapeutic, which is being developed as a functional cure for chronic hepatitis B in patients with diverse genetic backgrounds.
The obesity market has been gaining a lot of attraction from investors lately due to the success of the Danish pharma giant Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy (semaglutide injection 2.4mg).
Wegovy, a GLP-1 receptor agonist, was first approved in the United States in 2021 for weight management in people living with obesity. It is indicated for adults as well as pediatric patients aged 12 years and older.
Last week, Novo Nordisk announced the launch of Wegovy in the U.K. in a controlled and limited fashion. The demand for the drug has been so high since launch that the company is struggling to tackle the supply constraints related to Wegovy. The U.K. became the fifth country where Novo Nordisk launched Wegovy after the United States, Norway, Denmark and Germany.
Due to the increasing demand for weight loss products, Pfizer (PFE - Free Report) and Eli Lilly (LLY - Free Report) are also trying to gain a foothold in the obesity care market.
In May 2023, Pfizer shared study data showing that its oral type II diabetes candidate, danuglipron, helped patients lose weight faster than Novo Nordisk’s popular diabetes weekly injection, Ozempic. Pfizer’s danuglipron is an orally administered, small-molecule GLP-1 receptor agonist, which is an easier-to-use formulation. But this has not been approved yet.
Pfizer had another orally administered drug in its obesity care pipeline, lotiglipron, which is also a GLP-1 receptor agonist. However, the clinical development of lotiglipron was terminated based on pharmacokinetic data from phase I drug-drug-interaction studies and laboratory measurements, showing elevated transaminases in phase I studies as well as in the ongoing phase II study of lotiglipron.
In June 2023, Pfizer announced that it is moving forward with the late-stage development ofdanuglipron to treat adult patients with obesity and type II diabetes mellitus. Pfizer’s present phase IIb study in obesity is fully enrolled and plans for the phase III study will be subject to results from the ongoing phase II study on the candidate.
Eli Lilly’s Mounjaro/tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), was launched in the United States last year for type II diabetes. Mounjaro has also shown a superior weight-loss reduction in two late-stage clinical studies (SURMOUNT-3 and SURMOUNT-4) for the obesity indication.
LLY has already filed regulatory applications seeking approval of Mounjaro for obesity and weight management in the United States and EU. In the United States, the FDA has assigned priority review to the regulatory filing. Lilly expects a decision from the regulatory body by the end of the year.
Image: Bigstock
Altimmune (ALT) Rises 7% on Completing Dosing in Obesity Study
Altimmune, Inc. (ALT - Free Report) , a clinical-stage company, announced completing the dosing of patients in a phase II study, evaluating the safety and efficacy of lead pipeline candidate, pemvidutide, in patients with obesity or overweight. Pemvidutide is the company’s novel, investigational GLP-1/glucagon dual receptor agonist, which is currently being developed to treat obesity and non-alcoholic steatohepatitis (NASH).
Per the press release, Altimmune’s phase II MOMENTUM study enrolled a total of 391 patients with obesity or overweight and without diabetes. The patients were divided into four cohorts receiving either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
The relative percentage change in body weight at week 48 compared with baseline is the primary endpoint of the MOMENTUM study. Other readouts from the mid-stage study include metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
ALT is on track to announce top-line results from the phase II MOMENTUM study in the fourth quarter of 2023.
The stock of the company rose 7.4% on Tuesday in response to the encouraging news. Year to date, shares of Altimmune have nosedived 84.1% compared with the industry’s 4.1% fall.
Image Source: Zacks Investment Research
We would like to remind the investors that in March 2023, Altimmune announced positive top-line results from its interim analysisof the MOMENTUM phase II obesity study on pemvidutide. The interim analysis data was from 160 subjects who completed 24 weeks of treatment.
However, a treatment discontinuation rate of 28.2% in subjects receiving the placebo and 24% in subjects receiving pemvidutide was observed in the first 16 weeks of treatment. Discontinuation of treatment with pemvidutide was mostly due to the adverse events observed. This did not impress investors leading to a massive drop in the stock price at the time.
Besides the obesity/overweight indication, Altimmune is also currently developing pemvidutide to treat NASH in a mid-stage study. Its pipeline also includes another candidate, HepTcell, a novel, investigational and immunotherapeutic, which is being developed as a functional cure for chronic hepatitis B in patients with diverse genetic backgrounds.
Altimmune, Inc. Price and Consensus
Altimmune, Inc. price-consensus-chart | Altimmune, Inc. Quote
The obesity market has been gaining a lot of attraction from investors lately due to the success of the Danish pharma giant Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy (semaglutide injection 2.4mg).
Wegovy, a GLP-1 receptor agonist, was first approved in the United States in 2021 for weight management in people living with obesity. It is indicated for adults as well as pediatric patients aged 12 years and older.
Last week, Novo Nordisk announced the launch of Wegovy in the U.K. in a controlled and limited fashion. The demand for the drug has been so high since launch that the company is struggling to tackle the supply constraints related to Wegovy. The U.K. became the fifth country where Novo Nordisk launched Wegovy after the United States, Norway, Denmark and Germany.
Due to the increasing demand for weight loss products, Pfizer (PFE - Free Report) and Eli Lilly (LLY - Free Report) are also trying to gain a foothold in the obesity care market.
In May 2023, Pfizer shared study data showing that its oral type II diabetes candidate, danuglipron, helped patients lose weight faster than Novo Nordisk’s popular diabetes weekly injection, Ozempic. Pfizer’s danuglipron is an orally administered, small-molecule GLP-1 receptor agonist, which is an easier-to-use formulation. But this has not been approved yet.
Pfizer had another orally administered drug in its obesity care pipeline, lotiglipron, which is also a GLP-1 receptor agonist. However, the clinical development of lotiglipron was terminated based on pharmacokinetic data from phase I drug-drug-interaction studies and laboratory measurements, showing elevated transaminases in phase I studies as well as in the ongoing phase II study of lotiglipron.
In June 2023, Pfizer announced that it is moving forward with the late-stage development ofdanuglipron to treat adult patients with obesity and type II diabetes mellitus. Pfizer’s present phase IIb study in obesity is fully enrolled and plans for the phase III study will be subject to results from the ongoing phase II study on the candidate.
Eli Lilly’s Mounjaro/tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), was launched in the United States last year for type II diabetes. Mounjaro has also shown a superior weight-loss reduction in two late-stage clinical studies (SURMOUNT-3 and SURMOUNT-4) for the obesity indication.
LLY has already filed regulatory applications seeking approval of Mounjaro for obesity and weight management in the United States and EU. In the United States, the FDA has assigned priority review to the regulatory filing. Lilly expects a decision from the regulatory body by the end of the year.
Zacks Rank
Altimmune currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.