Company anticipates first-in-human trials to start in Q4 2020
GAITHERSBURG, Md., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of multiple dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of NASH. The IND enabling studies were conducted in rats and cynomolgus monkeys. The Company believes the data provide clear validation of previously observed pharmacodynamic effects of the compound and pave the way for the anticipated Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials to start in Q4 2020, following the submission of a clinical trial application in Australia.
ALT-801 was well tolerated in both rats and cynomolgus monkeys and the no-observed-adverse-effect levels (NOAEL) in both species were at the highest doses tested. The most remarkable finding was significant weight loss versus the control groups in both species, which is an expected and desired property of ALT-801. Importantly, no evidence of significant GI toxicity or intolerability, including vomiting, was observed in the animals. GLP-1 receptor agonists and dual agonists that are approved or in clinical development have been associated with significant levels of nausea and vomiting and have typically required the use of dose-titration over several months. The observations from the recently completed toxicology studies suggest that ALT-801 can be expected to be well tolerated in humans and not require dose titration, potentially enabling higher levels of weight loss and liver fat reduction than existing GLP-1 receptor agonist based compounds.
The nonhuman primate data also showed an ALT-801 pharmacokinetic profile that is expected to support weekly dosing in humans. The Company believes that the proprietary EuPort™ modification on ALT-801 not only provides the longer half-life necessary for weekly dosing but also slows the rate of absorption of the compound into the bloodstream to avoid the tolerability issues typically associated with this class of agents. Based upon the successful completion of these preclinical toxicology studies, Altimmune plans to initiate first-in-human studies of ALT-801 in Q4 2020, with data readouts on safety, pharmacokinetics, and important measures of activity such as weight loss and liver fat reduction in the Spring of 2021.
“Currently there are no approved treatments for NASH, and disease prevalence is growing worldwide as a consequence of an expanding obesity epidemic. These data are right in line with our expectation for ALT-801 and provide additional confidence as we look forward to initiating the first-in-human studies later this year,” said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. Dr. Garg continued, “In addition to our significant efforts to develop a vaccine and a treatment for COVID-19, we are pleased to continue the development of other therapeutic candidates of importance to public health across our product portfolio.”