GAITHERSBURG, Md. – Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, has announced the successful alignment with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registrational program for pemvidutide, its obesity treatment candidate. This follows a comprehensive review of preclinical and clinical data, including results from six prior clinical trials.
The Phase 3 program, which is set to enroll approximately 5,000 subjects across four trials, aims to evaluate the safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg over a 60-week period. These trials are designed to leverage pemvidutide's potential benefits, such as balanced GLP-1/glucagon dual agonism, which is believed to mimic the effects of diet and exercise by suppressing appetite and increasing energy expenditure.
The four trials, named VELOCITY-1 through VELOCITY-4, will assess pemvidutide's impact on body weight, waist circumference, serum lipids, blood pressure, and liver fat, among other endpoints. VELOCITY-2 will also examine the drug's effects on patients with obesity or overweight and elevated LDL cholesterol levels, including those not achieving target levels on statin therapy. VELOCITY-4 will focus on body composition and functional measures in an elderly population, particularly those with sarcopenia at baseline.
Dr. Vipin K. Garg, CEO of Altimmune, expressed confidence in pemvidutide's potential to address obesity and its comorbidities. Dr. Scott Harris, Chief Medical (TASE:PMCN) Officer, highlighted pemvidutide's differentiation from other incretin-based agents and its potential for lipid-lowering effects, liver fat reduction, and lean mass preservation.
Pemvidutide, a GLP-1/glucagon dual receptor agonist, has shown promising results in weight loss, lean mass preservation, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure in clinical trials. It has received Fast Track designation from the FDA for the treatment of MASH and is currently being studied in an ongoing Phase 2b MASH trial.
Altimmune is focused on developing peptide-based therapeutics for obesity and MASH. This announcement is based on a press release statement.
In other recent news, Siemens AG (OTC:SIEGY) is acquiring Altair Engineering Inc. for $10.6 billion, marking a significant expansion into the industrial software market. This move places Siemens (ETR:SIEGn) in direct competition with industry giants in a market currently valued at approximately $21.5 billion a year. Meanwhile, Altimmune, Inc., a clinical-stage biopharmaceutical company, has completed patient enrollment for its Phase 2b IMPACT trial evaluating the safety and efficacy of pemvidutide. The company expects to release top-line efficacy data in the future. JMP Securities analysts maintain a "MARKET OUTPERFORM" rating for Altimmune, indicating the high potential of pemvidutide. In other company news, Altimmune's Chief Financial Officer, Richard Eisenstadt, has unexpectedly passed away, with the existing finance and accounting team managing his responsibilities. Altimmune also announced that board member Dr. David J. Drutz will not stand for re-election at the upcoming Annual Meeting of Shareholders.
InvestingPro Insights
Altimmune's recent announcement regarding the FDA alignment on its Phase 3 program for pemvidutide comes at a time when the company is experiencing significant market momentum. According to InvestingPro data, Altimmune has seen a strong return of 19.84% over the last month and an impressive 170.74% over the past year, indicating growing investor confidence in the company's pipeline and potential.
Despite these positive returns, InvestingPro Tips highlight that Altimmune is not currently profitable and suffers from weak gross profit margins. This is not uncommon for clinical-stage biopharmaceutical companies investing heavily in research and development. The company's revenue for the last twelve months as of Q2 2023 stands at $0.41 million, with a substantial revenue growth of 604.94% during this period, reflecting the early stage of its commercial development.
Interestingly, an InvestingPro Tip notes that Altimmune holds more cash than debt on its balance sheet, which could provide financial flexibility as it advances its clinical programs, particularly the ambitious Phase 3 trials for pemvidutide. This solid financial position may be crucial for supporting the extensive VELOCITY trials outlined in the article.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Altimmune, providing deeper insights into the company's financial health and market position.
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