Altimmune Inc (NASDAQ:ALT) is continuously pursuing the development of immune-modulating therapies, the primary focus being treatments for liver disease. In its diverse pipeline, the company boosting proprietary intranasal vaccines for COVID-19 (AdCOVID™), influenza (NasoVAX™), and anthrax (NasoShield™), among others. In the recent past, the company has been carrying out multiple dose toxicity and toxicokinetic studies of ALT-801, one of the next generation peptide therapeutics for Non-Alcoholic SteatoHepatitis (NASH).
Rats and cynomolgus monkeys were the subjects of the studies, and Altimmune says the results were positive. A clear endorsement of previously observed pharmacodynamic effects of the compound was reported.
ALT-801 can be expected to be Well Tolerated in Humans
Some of the most significant observations from the studies of ALT-801 were weight loss versus the control groups in both species. However, this was expected but, most importantly, notable absence of GI toxicity or intolerability such as vomiting. Previously, there has been substantial levels of nausea and vomiting from GLP-1 receptor agonists, and dual agonists approved or in clinical development. Meanwhile, no-observed-adverse-effect levels (NOAEL) were only observed at the highest doses tested.
That said, it is possible that ALT-801 could be well tolerated in humans and may not need dose titration. This means higher levels of weight loss as well as liver fat reduction compared to when there is the usage of GLP-1 receptor agonist based compounds. Additionally, the nonhuman primate data is also likely to support weekly dosing in humans. There is a planned launch of the first-in-human studies of ALT-801 in Q4 2020
There are no Approved Treatments for NASH
The world and the pharmaceutical industry may have redirected its energies to the development of a COVID-19 pandemic. However, it remains a majority of diseases do not have known or approved treatments. NASH is one of them even though its prevalence is growing worldwide due to an expanding obesity epidemic. However, according to Altimmune’s CEO Dr. Vipin K. Garg, they are optimistic about their ability to develop important therapeutic candidates, which can meet the current market demand.
In line with all these and from ALT-801’s data, the company says it is anticipating to start Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials.