GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has Granted Fast Track designation for its clinical program investigating pemvidutide for the treatment of NASH.
NASH is a serious, potentially life-threatening disease and a leading cause of liver failure and liver transplantation worldwide. NASH is a growing public health problem for which there are currently no approved treatments. Fast Track designation is designed to facilitate the development and expedite review of new drugs designed to treat serious diseases and address unmet medical needs.
“The FDA’s decision is based on Altimmune’s study results, including its Phase 1b randomized, placebo-controlled study in subjects with non-alcoholic fatty liver disease (NAFLD), which showed a relative reduction in liver fat and NAFLD. Class leading position. “Alcoholic fatty liver disease (NAFLD) is an aggressive marker of liver inflammation and has a favorable safety and tolerability profile,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “The Fast Track designation reflects Altimmune’s commitment to patients with NASH and its efforts to find safe and effective treatments for this disease. “
IMPACT is evaluating the efficacy and safety of pemvidutide in NASH in a Phase 2b randomized, placebo-controlled biopsy-driven trial that is being conducted at approximately 60 sites in the U.S. in approximately 190 patients with and without diabetes subjects were enrolled. The primary efficacy endpoint is NASH regression and fibrosis improvement at 24 weeks of treatment, and subjects will need to be followed for an additional 24 weeks, for a total of 48 weeks, to understand safety and biomarker responses. In addition to IMPACT, MOMENTUM is evaluating the efficacy and safety of pevitide in the treatment of obesity in a Phase 2b randomized, placebo-controlled trial being conducted at approximately 30 sites in the United States. A 24-week interim analysis was completed in 160 subjects. Treatment reports are due in the first quarter of 2023, with complete results expected later this quarter from 391 subjects who received up to 48 weeks of treatment.
About pevidide
Pemvidutide is a novel, investigational, peptide-based dual GLP-1/glucagon receptor agonist being developed to treat obesity and NASH. Activation of GLP-1 and glucagon receptors is thought 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 thought to have a direct effect on liver fat metabolism, leading to a rapid reduction in liver fat levels. Pemvidutide incorporates a EuPort™ domain, a proprietary technology that increases serum half-life with weekly dosing while potentially slowing the rate at which Pemvidutide enters the bloodstream, thereby increasing its tolerability.
About Altimmune
Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation therapies to treat obesity and liver disease. The company’s lead product candidate, pemvidutide, is a dual GLP-1/glucagon receptor agonist being developed to treat obesity and NASH. Additionally, Altimmune is developing HepTcell™, an immunotherapy designed to achieve a functional cure for chronic hepatitis B. For more information, please visit www.altimmune.com.
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forward-looking statements
Any statements in this press release regarding future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters, including, without limitation, the timing of key milestones for our clinical assets and the performance of any product or drug candidate. availability, regulatory approval, marketing or sales, 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,” “forecast” and similar expressions and variations thereof related to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to a number of assumptions, risks and uncertainties that Properties may change over time. Important factors that could cause actual results to differ materially from those discussed in forward-looking statements or historical experience include risks and uncertainties, including risks related to: delays in regulatory review, Disruptions to manufacturing and supply chains, access to clinical sites, enrollment, adverse effects on the healthcare system and disruption to the global economy; Reliability of study results related to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; The Company has the ability to produce clinical trial materials on expected schedules; and the success of future product advancements, including the success of future clinical trials. For more information about the factors and risks that could affect the company’s business, financial condition and results of operations, please see the company’s filing with U.S. Securities Exchange Commission filings, including the information under the heading “Risk Factors” in the company’s most recent annual report on Form 10-K and our other SEC filings, are available at www.sec.gov.
Investor contact information:
Rich Eisenstat
CFO
Phone: 240-654-1450
reisenstadt@altimmune.com
Media contact information:
Danielle Canty
evoke canal
Phone: 619-826-4657
danielle.cantey@evokegroup.com
