GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced a preclinical data presentation on ALT-801, its balanced and long-acting GLP-1/glucagon receptor dual agonist under development for NASH, at the Digital International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually from August 27, 2020 to August 29, 2020.
“We are excited to share the compelling preclinical body of work on the weight loss, NASH improvement and gene regulatory signatures induced by ALT-801 at EASL as we prepare to commence our first in human Phase 1 trial next quarter,” said M. Scott Harris, M.D., Chief Medical Officer of Altimmune. Dr. Harris continued, “As the Gubra mouse model has historically translated well into human studies, we believe that the data from this study will position ALT-801 as a promising candidate for NASH.”
Employing the well-established Gubra mouse model, animals with biopsy-confirmed NASH received ALT-801 (5 or 10 nmol/kg), semaglutide (10 nmol/kg), a GLP-1 receptor agonist or vehicle subcutaneously for 12 weeks. ALT-801 demonstrated statistically superior reductions (p ≤ 0.05) in body weight, liver weight, plasma ALT, liver triglycerides and cholesterol, plasma cholesterol, NAFLD activity scores, and fibrosis markers compared to semaglutide. Principal component analysis differentially clustered genes regulated by ALT-801 from those regulated by semaglutide, consistent with a unique gene regulatory signature associated with glucagon receptor activation. ALT-801 also resulted in greater suppression of archetypal genes involved in de novo lipogenesis and fatty acid uptake, inflammation, hepatocellular death, fibrosis and stellate cell activation than semaglutide.
The Phase 1 trial will be conducted in Australia and will evaluate the safety, pharmacokinetics and activity of ALT-801 over 6 weeks treatment in overweight and obese volunteers. The readout from this study, which will include validation of the compound’s weight loss and liver fat-reducing effects observed in preclinical studies, is expected in the spring of 2021.
Details for the poster presentation are as follows:
|Title:||GLP-1/Glucagon Dual Receptor Agonist ALT-801 is Superior to Semaglutide in Improving NASH Endpoints in a Biopsy-Confirmed DIO Mouse Model (FRI-117)|
|Presenter:||M. Scott Harris M.D., Chief Medical Officer of Altimmune. Inc.|
|Date/Time:||August 28, 2020 at 8:30 to 18:30 GMT|
A copy of the poster will be accessible on the Events section of the Altimmune website.
ALT-801 is a novel peptide-based dual GLP-1/glucagon receptor agonist that is designed to treat the obesity and metabolic dysfunction that causes non-alcoholic steatohepatitis, or NASH. NASH, the most severe form of non-alcoholic fatty liver disease, or NAFLD, involves multiple metabolic pathways leading to the abnormal accumulation of liver fat, toxic lipid metabolites, and inflammation, leading to fibrosis or eventually liver cancer. We believe the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH. As observed in a well-established preclinical model of the disease, ALT-801 was capable of inducing significant weight loss with concomitant decreases in liver fat, inflammation and fibrosis.
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
Any 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 key milestones for our clinical assets, the initiation and timing of the ALT-801 Phase 1 clinical trial in Q4 2020, the timing of the date readout expected in the spring of 2021, our ability to manufacture ALT-801, and the prospects for 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. (the “Company”) 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: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, 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 secure regulatory approval for its ALT-801 investigational new drug application submission to the U.S. Food and Drug Administration, 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 annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.
|Will Brown||Ashley R. Robinson|
|Chief Financial Officer||LifeSci Advisors, LLC|
|Sard Verbinnen & Co.|