Altimmune, Inc.

GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that new data showing reductions of multiple classes of atherogenic and cardio-inflammatory lipids in subjects treated with pemvidutide will be presented in a poster session at The Liver Meeting® 2024 of the American Association for the Study of Liver Diseases (AASLD) in San Diego, CA taking place November 15-19, 2024. The data were derived from Altimmune’s 12-week Phase 1b randomized, placebo-controlled study in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD), a precursor to the more serious metabolic dysfunction-associated steatohepatitis (MASH). The Company has completed enrollment in a Phase 2b efficacy trial of pemvidutide in patients with biopsy-confirmed F2/F3 MASH, with topline data expected in the second quarter of 2025. Details of the presentation are as follows: Title:Effect of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Plasma Lipidomic Profiles in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Presenter:Dr. Sarah K. Browne, Vice President, Clinical Development, AltimmuneDate/Time:Friday, November 15, 2024, at 1:00 pm PST The poster will be available on the Events section of the Altimmune website at the time of the presentation. About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. 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 compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure, while preserving lean mass. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on Twitter Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contacts:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com This press release was published by a CLEAR® Verified individual.

IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025 End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024 Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4 2024 GAITHERSBURG, Md., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide. “We continue to make important advancements in the development of pemvidutide and are excited to have completed enrollment in the IMPACT trial, with top-line efficacy data expected in the second quarter of 2025,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We are also excited to have received FDA confirmation of the End-of-Phase 2 meeting for our obesity program, which is scheduled for early November. Furthermore, we are planning to file INDs for Phase 2 studies of pemvidutide in up to three additional indications. These initiatives are expected to expand the differentiation of pemvidutide in the metabolic disease space and enhance its long-term value proposition.” “IMPACT will be the first incretin-based study to read out on a biopsy-driven fibrosis endpoint at only 24 weeks. I believe the combination of direct liver effects and weight loss conferred by pemvidutide offers an important advantage over other approaches to the treatment of MASH and I look forward to the results of the IMPACT trial with great optimism,” said Dr. Mazen Noureddin, M.D., MHSc, Professor of Medicine at Houston Methodist Hospital, Director, Houston Research Institute and Principal Investigator on the IMPACT trial. “We look forward to aligning with the FDA on our Phase 3 clinical development plan for pemvidutide in obesity at our End-of-Phase 2 meeting in early November,” added Dr. Garg. “Our proposed registrational program leverages the unique attributes of pemvidutide, which we believe will benefit patients with obesity, excess liver fat and elevated serum lipids while preserving lean mass.” Altimmune also expects to file IND applications for pemvidutide in up to three additional indications with the first of these IND submissions in Q4 2024. The company plans to disclose details on these indications following alignment with the FDA. Preparations for the first trial are underway, with initiation planned for H1 2025. “We believe we have strong scientific rationale to support the development of pemvidutide in these additional indications, all of which are areas of high unmet medical need, where we believe its balanced GLP-1/glucagon dual agonism could allow for differentiation from other approaches,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. About PemvidutidePemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. 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 compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure, while preserving lean mass. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. About AltimmuneAltimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Forward-Looking StatementAny statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of the IMPACT trial data readout, the timing of the planned End-of-Phase 2 FDA meeting, the timing of the planned IND submissions for pemvidutide, the timing of key milestones for any of 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:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contacts:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com This press release was published by a CLEAR® Verified individual.

A scale and fat cells Taylor Tieden for BioSpace In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. The global obesity market is forecasted to reach between $100 billion and $160 billion in the next decade. Meanwhile, the market for type 2 diabetes, which is closely related, is predicted to exceed $70 billion by 2032. There is thus considerable opportunity for Novo Nordisk, Eli Lilly, Pfizer and the multitude of other biopharma companies vying for a piece of the lucrative pie. Weight-Loss Market Estimates and Projections Source: IQVIA, Reuters, Goldman Sachs Taylor Tieden for BioSpace While exceedingly successful, many suspect the current GLP-1 injection therapies for obesity will ultimately be replaced by oral GLP-1 drugs, and several companies, including Lilly, Novo and Pfizer, are racing to bring their versions to the market. In addition, the space is not limiting itself to GLP-1s but is also exploring novel mechanisms to tackle these widespread diseases. Here, BioSpace examines the current obesity and diabetes markets along with the growing pipelines that aim to serve them. Weight Loss: A Two-Horse Race The obesity market is currently dominated by two companies: Novo Nordisk and Eli Lilly. While Novo’s obesity drug Wegovy had a two-year head start on Lilly’s Zepbound, the latter is making up ground . On August 7, Novo reported its second-quarter earnings , revealing profits of $1.7 billion for Wegovy and $4.23 billion for diabetes drug Ozempic. Despite growth rates of 53% and 30%, respectively, for the drugs, investors were not impressed because analyst forecasts were missed. Lilly, on the other hand, beat Q2 expectations , bringing in $1.24 billion for Zepbound and $3.1 billion for diabetes treatment Mounjaro. But the future is much more than a two-horse race. Several companies, including Pfizer , Roche , Viking Therapeutics , and Rivus Pharmaceuticals, are developing obesity therapeutics. Some leverage the GLP-1 pathway, while others commit to different mechanisms, including amylin analogs and mitochondrial uncoupling. Other players in the space include Veru Pharmaceuticals, Regeneron, Altimmune, Amgen, and Amylyx. Approval Timeline The obesity space truly caught fire with the clinical success of Wegovy and Zepbound, but these products follow several other treatments for obesity and diabetes approved over the past two-plus decades. Here is a sampling of noteworthy products. November 2023 Eli Lilly, Zepbound Generic name: Tirzepatide Treatment: Weight management June 2022 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in pediatric patients May 2022 Eli Lilly, Mounjaro Generic name: Tirzepatide Treatment: Type 2 diabetes June 2021 Novo Nordisk, Wegovy Generic name: Semaglutide Treatment: Obesity December 2020 Novo Nordisk, Saxenda Generic name: Liraglutide Treatment: Obesity in adolescents September 2019 Novo Nordisk, Rybelsus Generic name: Semaglutide Treatment: Type 2 diabetes (pill form) December 2017 Novo Nordisk, Ozempic Generic Name: semaglutide Treatment: Type 2 diabetes September 2014 Takeda, Contrave Generic names: Naltrexone and bupropion Treatment: Weight loss July 2012 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in adult patients January 2010 Novo Nordisk, Victoza Generic name: Liraglutide Treatment: Type 2 diabetes April 2005 Amylin Pharmaceuticals, Byetta Generic name: Exenatide Treatment: Type 2 diabetes The Highly Sought Weight-Loss Pill In 2019, the FDA approved Novo’s Rybelsus as the first oral GLP-1 for type 2 diabetes. Considered by many to be the next frontier in obesity treatment, oral medicines are under development by a number of companies, including Novo, whose amycretin is in Phase I trials, and Lilly, which has a Phase III trial underway for orforglipron. Brazilian owned multinational company Eurofarma also has a Phase III study underway for its oral candidate sibutramine/topiramate XR. Meanwhile, a host of companies have oral assets in earlier-stage trials. Pfizer recently announced that it would move forward with a modified-release formulation of its candidate danuglipron, and in December 2023, San Francisco–based Structure Therapeutics announced positive results from a Phase IIa trial of its weight-loss pill GSBR-1290. Note: Not all companies with oral medicines in Phase I and II trials are included. Taylor Tieden for BioSpace Widely hailed as “the next big thing” in the obesity space, several companies—including Eli Lilly, Novo Nordisk and Pfizer—are developing oral GLP-1 candidates. How long before oral GLP-1s take majority share of the market? Source: BioSpace LinkedIn poll , August 2024 Taylor Tieden for BioSpace This deep dive was originally published as a special edition of ClinicaSpace. Subscribe here .