GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ: NASDAQ:ALT), a clinical-stage biopharmaceutical company, has announced the completion of patient enrollment for its Phase 2b IMPACT trial, which evaluates the safety and efficacy of pemvidutide in subjects with metabolic dysfunction-associated steatohepatitis (MASH). The company expects to release top-line efficacy data in the second quarter of 2025.
The IMPACT trial is notable for being the first incretin-based study to assess a biopsy-driven fibrosis endpoint at only 24 weeks. Dr. Mazen Noureddin, the Principal Investigator on the IMPACT trial, expressed optimism about the potential benefits of pemvidutide, citing its direct effects on the liver and weight loss as key advantages over other treatments for MASH.
In addition to the MASH study, Altimmune is preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding their obesity program, scheduled for early November 2024. The company aims to align with the FDA on a Phase 3 clinical development plan for pemvidutide in obesity, leveraging what it believes are the drug's unique attributes.
Altimmune also plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications, with the first submission expected in the fourth quarter of 2024. Details on these indications will be disclosed following discussions with the FDA, and the first trial is planned to commence in the first half of 2025.
Pemvidutide is a peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. It has been granted Fast Track designation by the FDA for the treatment of MASH. In clinical trials, pemvidutide has shown promising results, including significant weight loss and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure, while preserving lean mass.
The information in this article is based on a press release statement from Altimmune, Inc.
In other recent news, Altimmune Inc. has reported significant advancements in its pemvidutide program for obesity and non-alcoholic steatohepatitis (NASH). The biopharmaceutical company's Phase 2 clinical trial for this investigational obesity treatment showcased substantial reductions in liver fat content, improvements in body weight, and markers of liver inflammation. The company also announced its plans to discuss Phase 3 guidance with the FDA in Q3 2024, with an expectation to release top-line results from the ongoing IMPACT study for NASH in Q1 2025.
In other recent developments, Altimmune confirmed the results of its 2024 Annual Meeting of Stockholders, which saw the election of directors and the ratification of the company's independent auditor, Ernst & Young LLP. However, shareholders demonstrated a divided stance on executive compensation.
In addition, Altimmune announced that board member Dr. David J. Drutz will not stand for re-election at the upcoming Annual Meeting of Shareholders. Following the unexpected passing of the company's Chief Financial Officer, Richard Eisenstadt, the existing finance and accounting team is managing his responsibilities.
JMP Securities analysts maintain a "MARKET OUTPERFORM" rating for Altimmune, indicating the high potential of pemvidutide. These recent developments highlight the ongoing progress and challenges at Altimmune as it continues to advance its clinical programs.
InvestingPro Insights
As Altimmune (NASDAQ: ALT) progresses with its clinical trials for pemvidutide, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $459.83 million, reflecting investor expectations for its pipeline.
InvestingPro data shows that Altimmune's revenue growth over the last twelve months as of Q2 2024 was an impressive 604.94%, indicating significant expansion. However, this growth comes with challenges, as evidenced by the company's negative gross profit margin and operating income margin.
Two relevant InvestingPro Tips highlight Altimmune's financial position:
1. The company is quickly burning through cash, which is crucial to monitor given the ongoing clinical trials and potential future drug development costs.
2. Altimmune holds more cash than debt on its balance sheet, providing some financial flexibility as it advances its clinical programs.
These insights are particularly relevant given Altimmune's focus on completing the IMPACT trial and preparing for potential Phase 3 trials in obesity. The company's cash position will be critical in supporting these initiatives and potential IND applications for additional indications.
It's worth noting that while Altimmune's stock has taken a significant hit over the last week (-10.14%) and year-to-date (-42.49%), it has shown a strong return of 148.85% over the past year. This volatility underscores the speculative nature of biotech investments, especially for companies in the clinical stage like Altimmune.
Investors interested in a deeper analysis can find 11 additional InvestingPro Tips for Altimmune, offering a more comprehensive view of the company's financial health and market position.
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