Clinical-stage biopharmaceutical company Altimmune Inc. (ALT:NASDAQ), which is engaged in the development of treatments for liver disease, intranasal vaccines and immune modulating therapies, today announced "results from a prespecified 6-week interim analysis of its ongoing 12-week, Phase 1, placebo-controlled, single and multiple ascending dose trial of ALT-801, an investigational GLP-1/glucagon dual receptor agonist, in healthy overweight and obese volunteers." The firm advised that the ongoing study is presently being conducted under a clinical trial application in Australia.
Altimmune stated that the interim data showed that after six weeks of a once-weekly subcutaneously administered dose of 1.8 mg ALT-801, treated trial participants showed a mean weight loss of 5.4%, compared to a gain in weight of 0.9% in the control group. The company noted that the results had surpassed the study's targeted 2% weight loss goal. The firm noted as well that another cohort in the Phase 1 trial achieved a mean weight loss of 1.8% when given a lower 1.2 mg once-weekly dosage.
Stephen Harrison, M.D., visiting professor of hepatology at the University of Oxford and medical director of Pinnacle Research, remarked, "These data are encouraging considering that only a 2% weight loss was targeted at 6 weeks of treatment and that nausea rates were low, without emesis, which is particularly notable in the absence of dose titration…The high degree of weight loss, the very good safety and tolerability profile, and the absence of dose titration with short treatment duration is very favorable for ALT-801 and makes it an attractive candidate among the GLP-1 class of drugs. Based on the relationship between weight loss and liver fat reduction, and NASH resolution observed in other studies, ALT-801 appears to be a promising therapeutic candidate for both obesity and NASH."
The company advised that the study enrolled mostly young and non-diabetic patients and added the proportion of subjects with MRI-PDFF higher than 10% was not sufficient to perform a liver fat reduction analysis. Altimmune indicated that because of that information, "it plans to expand the enrollment criteria and conduct a separate 12-week Phase 1b study of diabetic and non-diabetic subjects with non-alcoholic fatty liver disease (NAFLD) in the U.S." The firm said it expects that the new study will begin during Q3/21 and that in Q1/22 it additionally plans to initiate a 52-week biopsy-driven NASH trial.
Altimmune stated that it is actively advancing higher dose treatments cohorts in the ALT-801 Phase 1 study and expects to report the data from the escalated dose groups in Q3/21 after those enrollees have competed 12 weeks of treatment. The company pointed out that "based on these latest results, it now plans to file a second IND in obesity in Q3/21 to supplement its ongoing NASH program."
The company's President and CEO Vipin K. Garg, Ph.D., commented, "We are very excited about the potential for ALT-801 in the expanding GLP-1 therapeutics marketplace…We know that weight loss is strongly correlated with NASH resolution and that the obesity epidemic in developed nations has led to an unacceptable increase in chronic illnesses. Assuming ALT-801 is shown to improve upon the metabolic control and side effect profile of existing GLP-1 therapies, we believe that ALT-801 could enable more patients to benefit from this type of treatment."
The company explained that "ALT-801 is a novel, investigational, peptide-based dual GLP-1/glucagon receptor agonist that is designed to treat the obesity and metabolic dysfunction that causes NASH," noting that NASH is "the most severe form of non-alcoholic fatty liver disease, or NAFLD,"
Altimmune is a clinical stage biopharmaceutical company based in Gaithersburg, Md., that is engaged in the development of treatments for liver disease, immune modulating therapies and intranasal vaccines. The firm stated that "its 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™)."
Altimmune started the day with a market cap of around $542.5 million with approximately 38.4 million shares outstanding and a short interest of about 11.0%. ALT shares opened 2% higher today at $14.44 (+$0.31, +2.19%) over yesterday's $14.13 closing price. The stock has traded today between $14.35 and $19.46 per share and closed for trading at $16.46 (+$2.33, +16.49%).
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