Preclinical data suggest potential for ALT-801 to address a significant unmet medical need; Phase 1 data readout anticipated in Q2 2021
GAITHERSBURG, MD, USA I December 08, 2020 I Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has commenced dosing in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical study of ALT-801. 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 United States.
The Phase 1 clinical trial is being conducted in Australia and is expected to enroll approximately 50 and 60 volunteers in the SAD and MAD phases of the trial, respectively. The 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. 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 significant need for an effective, well-tolerated treatment for NASH,” said 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, an 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.”
About ALT-801
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. Altimmune believes the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH. 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.
About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our 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™). For more information on Altimmune, please visit www.altimmune.com.
SOURCE: Altimmune
Post Views: 103
Preclinical data suggest potential for ALT-801 to address a significant unmet medical need; Phase 1 data readout anticipated in Q2 2021
GAITHERSBURG, MD, USA I December 08, 2020 I Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has commenced dosing in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical study of ALT-801. 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 United States.
The Phase 1 clinical trial is being conducted in Australia and is expected to enroll approximately 50 and 60 volunteers in the SAD and MAD phases of the trial, respectively. The 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. 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 significant need for an effective, well-tolerated treatment for NASH,” said 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, an 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.”
About ALT-801
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. Altimmune believes the treatment of obesity is the cornerstone of treating NASH and the principal morbidities of NASH. 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.
About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our 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™). For more information on Altimmune, please visit www.altimmune.com.
SOURCE: Altimmune
Post Views: 103
