Innovative Peptide Study Evaluates Reduction in Liver Fat and Increased Weight Loss

A clinical-stage biopharmaceutical company announced that it has commenced dosing in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical study of ALT-801. 

Altimmune, Inc. stated in a press release that ‘ALT-801 is a long-acting GLP-1/glucagon receptor dual agonist being developed for the treatment of non-alcoholic steatohepatitis (NASH), which is expected to affect more than 13 million adults in the USA.’

Altimmune ‘believes the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH,’ added this press statement.

The Phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and activity of ALT-801 over 6-weeks of treatment in overweight and obese but otherwise normal volunteers, located in Australia.

Readouts from the trial, including initial weight loss and liver fat reduction, are expected in the second quarter of 2021. 

This 6-week study will be followed by a 12-week Phase 1b study in volunteers with non-alcoholic fatty liver disease (NAFLD) and is expected to commence in the third quarter of 2021.

“There is a significant need for an effective, well-tolerated treatment for NASH,” commented Scott Harris, M.D., Chief Medical Officer of Altimmune. “Unlike other metabolic approaches to treat NASH, ALT-801 combines the balanced, equipotent effects of GLP-1 and glucagon activities into a single peptide.”

“The approach is expected to provide optimal effects in activating both a satiety signal to reduce appetite while also stimulating energy expenditure to promote a reduction in liver fat and increased weight loss.” 

The Company anticipates that ALT-801, administered once-weekly, will have a favorable pharmacokinetic profile and improved gastrointestinal (GI) tolerability due to the proprietary EuPort™ domain, which slows the entry of the drug into the circulation. 

As GI intolerability is a significant limiting factor with all current GLP-1 based treatments, and improved tolerability profile is expected to be regarded favorably among clinicians. We look forward to a readout from the study in the second quarter of 2021, which could support strong competitive positioning for ALT-801 in the NASH treatment landscape.”

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 NASH. As the most severe form of non-alcoholic fatty liver disease, or NAFLD, NASH involves multiple metabolic pathways leading to the abnormal accumulation of liver fat, toxic lipid metabolites, and inflammation, resulting ultimately in fibrosis (cirrhosis) or liver cancer. 

As observed in a well-established preclinical model of the disease, ALT-801 was capable of inducing significantly greater weight loss compared to semaglutide, a GLP-1 receptor agonist, along with significantly greater decreases in liver fat, plasma ALT, and other markers of NASH.

Altimmune is a clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune-modulating therapies, and treatments for liver disease. 

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