We also announced that we have completed enrollment for a 12-week phase 1b study of pembijutide in subjects with non-alcoholic fatty liver disease (NAFLD).
Gaithersburg, Maryland, April 1, 2022 (GLOBE NEWSWIRE)-Clinical biopharmacy company Ultimatemune, Inc. (Nasdaq: ALT) is today the first subject in a 48-week Phase 2 MOMENTUM trial. Announced that it has registered.Assessment of safety and efficacy of pembijutide1 Obese or overweight subjects. Pemvidutide is a new clinical trial GLP-1 / glucagon double receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). We also announced today that we have completed enrollment in a 12-week Phase 1b clinical trial of pembijutide in subjects with non-alcoholic fatty liver disease (NAFLD).
The 48-week MOMENTUM trial is being conducted at approximately 25 facilities in the United States and is led by Dr. Lou Aronne, a leader in obesity and obesity clinical trials. The randomized placebo-controlled trial will enroll approximately 320 non-diabetic patients randomized 1: 1: 1: 1 with 1.2 mg, 1.8 mg, 2.4 mg pembijutide or placebo weekly for 48 weeks. .. The primary endpoint of the study is the relative (percentage) change in body weight at 48 weeks compared to baseline, with additional readings including metabolism and lipid profile, cardiovascular measurements, and glucose homeostasis. The interim analysis is planned to assess changes in body weight 24 weeks after treatment and is scheduled for reading in the fourth quarter of 2022.
“The launch of the Phase 2 MOMENTUM obesity trial marks an important milestone in the development of pembijutide,” said Dr. Scott Harris, Chief Healthcare Officer at Ultimate. “Building on compelling Phase 1 clinical data, there is great potential for pembijutide to address the serious and widespread disease of obesity and its debilitating consequences.”
The results of a phase 1 study of pembidutide in obese or overweight individuals showed that 12 weekly subcutaneous doses of pembidutide averaged 10.3%, or about 20 pounds, weight loss without dietary or lifestyle changes. Indicates that was seen. If these effects continue, as expected, in a 48-week study, weight loss close to or equivalent to that of obesity surgery may be achieved. Side effects were mild to moderate and there were no serious or severe treatment-related adverse events without the dose escalation schedule commonly used with other therapies in this class.
Significant progress has also been made in the development of pembijutide for the treatment of NASH, including the completion of enrollment in a 12-week Phase 1b trial in patients with NAFLD and the start of a blinded 12-week NAFLD prolongation trial. It was seen. The 12-week Phase 1b NAFLD study is designed to evaluate the effect of pembijutide on hepatic fat in subjects with obesity or overweight and hepatic fat content of 10% or higher as measured by MRI-PDFF. Approximately 72 subjects with or without diabetes are randomized 1: 1: 1: 1 and receive weekly pembijutide 1.2 mg, 1.8 mg, 2.4 mg or placebo with 12 weeks of treatment. The primary endpoint of the study is MRI-PDFF reduction of liver fat, but the primary secondary endpoint is 12 reflecting the fact that obesity is the primary driver and more advanced of NAFLD. The rate of weight loss at the end of the weekly treatment. Form, NASH. Data retrieval from the 12-week trial is scheduled for the third quarter of 2022, and cumulative weight loss over the 24-week combined with the extended trial is expected to be reported in the fourth quarter of 2022.
About Pemvidutide
Pemvidutide is a novel clinical trial peptide-based GLP-1 / glucagon double receptor agonist under development for the treatment of obesity and NASH. Activation of GLP-1 and glucagon receptors is thought to mimic the complementary effects of diet and exercise on weight loss, and GLP-1 suppresses appetite and glucagon energy consumption. By combining GLP-1 and glucagon activity into a single peptide, pembijutide may achieve weight loss comparable to obesity surgery. Pembijutide has also been shown to increase the breakdown of fat and its recruitment in the liver. This can have beneficial effects not only on fat-related liver diseases such as NASH, but also on insulin resistance, a common problem in obese people. EuPort is built into PemvidutideTM Domains are a unique technique that prolongs serum half-life with weekly dosing while delaying the entry of pembijutide into the bloodstream and may improve tolerability. In Phase 1 clinical trials, pembijutide showed a marked reduction in body weight, liver fat, and serum lipids.
About Altimmune
Altimmune is a clinical stage biopharmacy company focused on developing new peptide-based therapies for the treatment of obesity and liver disease. The company’s flagship product candidate, pembijutide (ALT-801), is a GLP-1 / glucagon double receptor agonist being developed for the treatment of obesity and NASH. In addition, Ultimatemune is developing HepTcell ™, an immunotherapeutic drug designed to achieve functional treatment of chronic hepatitis B. For more information, please visit www.altimmune.com.
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Description of future prospects
A statement of future financial or business performance, terms, plans, outlooks, trends, or strategies, and other financial and business issues made in this press release. This includes, but is not limited to, the timing of major milestones in clinical assets, 12 weeks. Reads of Phase 1b NAFLD trials in Q3 2022, interim analysis of body weight in Pembijutide obesity trials in Q4 2022, weight loss readings in Pembijutide prolongation trials in Q4 2022, potential of Pembiducide Therapeutic effect, safety and tolerability of pemvidutide, regulatory approval prospects, and ability to produce pemvidutide for clinical trials and commercial needs are statements about the future outlook in the sense of civil securities litigation reform. .. 1995 law. In addition, if used in this press release, or if used, “possible,” “possible,” “should,” “expect,” “believe,” “believe.” “Estimates,” “Expectations,” “Intentions,” “Plans,” “Forecasts,” and similar expressions and variations thereof related to Altimmune, Inc. (“Company”) identify forward-looking statements. there is. We warn that these forward-looking statements are subject to many assumptions, risks, and uncertainties that change over time. Key factors that may cause actual results to differ materially from forward-looking statements or results discussed in past experience include risks and uncertainties, including risks related to: Supply chain disruptions, access to clinical settings, registration, adverse health care systems, global economic turmoil. Reliability of research results on human safety and possible adverse effects of administration of our product candidates. Our ability to manufacture clinical trial materials and commercial supplies on the expected timeline. Successful future product advances, including successful future clinical trials. Details regarding factors and risks that may affect our business, financial position and results of operations are contained in our filings with the US Securities and Exchange Commission. This includes the “Risk Factors” heading in our annual report on Form 10. -K for the fiscal year ending December 31, 2021 submitted to the SEC. It is available at www.sec.gov.
Altimmune Investor & Media Contact:
Rich Eisenstadt
CFO
Phone number: 240-654-1450
reisenstadt@altimmune.com
1 Proposed INN
