GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, has reported significant results from a 12-week clinical trial of pemvidutide for treating metabolic dysfunction-associated steatotic liver disease (MASLD).
The study, published in the Journal of Hepatology, indicated that weekly subcutaneous doses of pemvidutide led to a substantial reduction in liver fat content (LFC) and improvements in body weight and markers of liver inflammation.
According to the trial data, up to 68.5% relative reduction in LFC was observed in subjects receiving pemvidutide compared to a 4.4% reduction in those receiving a placebo. Notably, up to 55.6% of subjects treated with pemvidutide achieved LFC normalization, which is defined as an LFC of 5% or less, in contrast to none in the placebo group.
The trial involved 94 subjects with obesity or overweight and an LFC of 10% or higher. They were randomized to receive one of three dosages of pemvidutide or a placebo without any dietary or exercise interventions. The primary efficacy endpoint was the relative reduction in LFC from baseline.
The study also reported that up to 94.4% of subjects receiving pemvidutide achieved at least a 30% relative reduction in LFC, an important predictor of MASH resolution and fibrosis improvement, compared to only 4.2% receiving placebo. Significant reductions in body weight and established markers of MASH inflammatory activity, including alanine aminotransferase (ALT) and corrected T1 (cT1) MRI imaging, were also observed.
Pemvidutide was well-tolerated, with a low rate of adverse event discontinuations. No severe or serious adverse events were reported.
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist designed for the treatment of obesity and MASH. The drug's dual mechanism is believed to mimic the effects of diet and exercise by suppressing appetite and increasing energy expenditure, as well as having direct effects on hepatic fat metabolism.
Altimmune is looking forward to the results from the ongoing biopsy-driven Phase 2b IMPACT trial of pemvidutide in MASH, with data readout expected in Q1 2025. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH.
This analysis is based on a press release statement from Altimmune, Inc.
In other recent news, Altimmune Inc. has reported substantial advancements in its pemvidutide program for obesity and non-alcoholic steatohepatitis (NASH) during its first quarter 2024 earnings call.
Notably, the company has observed significant weight loss results from the Phase 2 MOMENTUM trial and plans to discuss Phase 3 guidance with the FDA in Q3 2024. Altimmune expects to release top-line results from the ongoing IMPACT study for NASH in Q1 2025. JMP Securities analysts maintain a "MARKET OUTPERFORM" rating for Altimmune, reflecting the high potential of pemvidutide.
In other developments, the company's Chief Financial Officer, Richard Eisenstadt, has unexpectedly passed away. His responsibilities are currently being managed by the existing finance and accounting team as the search for a new CFO is underway. Despite this loss, the company remains focused on its clinical programs.
Altimmune is also actively seeking a partnership for pemvidutide's Phase III development, with cash reserves projected to fund operations until the first half of 2026.
InvestingPro Insights
Amidst the promising clinical trial results for Altimmune's pemvidutide, a deeper look into the company's financial health reveals some key insights. According to InvestingPro data, Altimmune holds a market capitalization of $444.56 million. While the company's revenue showed an impressive growth of 618.99% in the last twelve months as of Q1 2024, it is important to note that this is from a low base, with total revenue recorded at $0.41 million. The revenue growth, however, experienced a quarterly decline of -76.19% in Q1 2024, indicating potential volatility in the company's revenue stream.
From a profitability perspective, the gross profit margin presents a challenge, standing at -16982.2% over the last twelve months as of Q1 2024, reflecting significant costs relative to the revenue generated. This aligns with one of the InvestingPro Tips, which points out that Altimmune suffers from weak gross profit margins. Additionally, analysts do not anticipate the company will be profitable this year, which is another crucial InvestingPro Tip to consider when evaluating the financial outlook of Altimmune.
Investors looking for comprehensive analysis and additional insights can find more InvestingPro Tips for Altimmune. There are a total of 11 additional tips available, which could provide a more nuanced understanding of the company's financial position and future prospects. For those interested, consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription at InvestingPro.
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