Altimmune will present Phase 2b trial data on pemvidutide for metabolic dysfunction-associated steatohepatitis on June 26, 2025.
Quiver AI Summary
Altimmune, Inc. will host an investor webcast on June 26, 2025, at 8:30 am ET to present topline data from its Phase 2b IMPACT trial, which evaluated the efficacy of pemvidutide in treating metabolic dysfunction-associated steatohepatitis (MASH). The conference call will feature remarks from company management and Dr. Mazen Noureddin. The IMPACT trial included 212 patients and aimed to assess the resolution of MASH or improvement in liver fibrosis after 24 weeks of treatment with either pemvidutide or a placebo. Pemvidutide, a dual receptor agonist, has shown promising results in previous trials, leading to its Fast Track designation by the FDA. The company anticipates a complete readout of the trial by the end of 2025.
Potential Positives
- Altimmune is presenting topline data from its IMPACT Phase 2b trial, highlighting the progress of pemvidutide in treating a significant metabolic condition, MASH.
- The U.S. FDA has granted Fast Track designation to pemvidutide, which could expedite its development and regulatory review process.
- Results from previous trials indicate pemvidutide's potential for significant health benefits, including MASH resolution and notable weight loss, enhancing the company's prospects in the biopharmaceutical market.
Potential Negatives
- No data is presented in this release from the ongoing IMPACT Phase 2b trial, which may lead to uncertainty among investors about the efficacy of pemvidutide.
- The reliance on forward-looking statements raises concerns regarding potential delays and risks that could significantly impact the company's operational and financial performance.
- The press release does not address the timeline for when the ongoing Phase 2 trials for Alcohol Use Disorder and Alcohol-associated Liver Disease will yield results, which could affect investor confidence.
FAQ
What is the date and time of the Altimmune investor webcast?
The Altimmune investor webcast will be held on June 26, 2025, at 8:30 am E.T.
What will be presented during the webcast?
The webcast will present topline 24-week data from the IMPACT Phase 2b trial evaluating pemvidutide for MASH treatment.
How can I access the conference call and webcast?
You can access the conference call and webcast on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors.
What is pemvidutide being developed for?
Pemvidutide is being developed for treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and ALD.
How many patients were enrolled in the IMPACT trial?
The IMPACT trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
GAITHERSBURG, Md., June 25, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, will host an investor webcast on Thursday, June 26, 2025 at 8:30 am E.T. to present topline 24 week data from its IMPACT Phase 2b trial evaluating pemvidutide in the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH).
Conference Call Information
The Company will host a conference call and webcast at 8:30 am E.T. on June 26, 2025. The call will include remarks from Altimmune management and Dr. Mazen Noureddin, Professor of Medicine at the Houston Methodist Hospital and Co-Chairman of the Board for Summit Clinical Research and Pinnacle Clinical Research. Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at
www.altimmune.com
.
Conference Call Details: | |
Date: | Thursday, June 26, 2025 |
Time: | 8:30 am Eastern Time |
Webcast: | To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors . |
Dial-in: | To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call. |
About the IMPACT Study
The IMPACT ( NCT05989711 ) trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive either weekly subcutaneous pemvidutide at 1.2 mg and 1.8 mg doses or placebo for 24 weeks. Key efficacy endpoints were MASH resolution or fibrosis improvement at 24 weeks. Secondary endpoints included weight loss and non-invasive tests. Patients will receive a total of 48 weeks of treatment, and a final readout is anticipated in the fourth quarter of 2025.
About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of MASH, obesity, Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD). Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated statistically significant MASH resolution and liver fibrosis improvement, compelling weight loss with class-leading lean mass preservation, and robust reductions in liver fat content, triglycerides, LDL cholesterol and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide completed the MOMENTUM Phase 2 obesity trial in 2024 and the ongoing IMPACT Phase 2b MASH trial, for which data will be reported on tomorrow’s call. IND applications in AUD and ALD have received FDA clearance, with a Phase 2 trial in AUD underway and a Phase 2 trial in ALD scheduled to commence in Q3 2025.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, obesity, AUD and ALD. For more information, please visit www.altimmune.com .
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Forward-Looking Statement
Any statements made in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, the timing of key milestones for our clinical assets, and the prospects for the utility of regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K and our other filings with the SEC, which are available at
www.sec.gov
.
Company Contact:
Greg Weaver
Chief Financial Officer
Phone: 240-654-1450
[email protected]
Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
[email protected]
Media Contact:
Jake Robison
Inizio Evoke, Biotech
Phone: 619-849-5383
[email protected]
This press release was published by a CLEAR® Verified individual.