Baseline Therapuetics, a startup biotech company developing addiction therapeutics, has launched with the aim of studying GLP-1s for therapeutic use in substance use disorders.
Baseline’s lead programme, BT-001, is a best-in-class, once-weekly GLP-1 receptor agonist (GLP-1RA) candidate being developed for alcohol use disorder (AUD), with additional substance use disorder indications planned.
BT-001 has extensive human experience in metabolic indications — including more than ten clinical trials and thousands of patients — supporting an outstanding safety profile.
"Alcohol use disorder affects roughly 29 million Americans, yet too few patients have access to medicines that deliver meaningful, durable benefit," said Dr Morris Birnbaum, Chief Scientific Officer and co-founder of Baseline and former Chief Scientific Officer for Internal Medicine at Pfizer.
"Emerging evidence suggests GLP-1 biology may influence core drivers of compulsive behaviour and craving."
"Baseline was formed to test that potential with the level of scientific rigour and pivotal-stage execution needed to support a new standard of care."
Baseline has stated that it plans to initiate two randomised, placebo-controlled Phase III studies of BT-001 in AUD in 2026, supported by an FDA-aligned development pathway.
Why this matters
An estimated 29 million Americans meet the criteria for AUD, underscoring the scale of the public health burden.
Despite this prevalence, only a small fraction receive evidence-based medication treatment, due to limited efficacy, tolerability and real-world appeal of current options.
There are also expansion plans for BT-001 in additional substance use disorder indications, including stimulant and opioid use disorders.
"Baseline has the team, infrastructure and clinical network required to deliver a high-quality pivotal programme in AUD," said Nicholas Reville, CEO and co-founder.
"We are prioritising execution: an FDA-aligned Phase III plan, a weekly dosing profile designed for adherence and a multi-indication strategy that can extend beyond AUD."
"We believe Baseline can help define a new standard of care in addiction medicine."