Baseline Therapeutics, Inc. (“Baseline”), a clinical-stage biotechnology company developing addiction therapeutics, today announced the launch of the company to advance a new generation of pharmacotherapies for substance use disorders.

Baseline’s lead program, 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 10 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 Morris Birnbaum, MD, PhD, 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 behavior and craving. Baseline was formed to test that potential with the level of scientific rigor and pivotal-stage execution needed to support a new standard of care.”

Baseline plans to initiate two randomized, placebo-controlled Phase 3 studies of BT-001 in AUD in 2026, supported by an FDA-aligned development pathway.

An estimated 29 million Americans meet criteria for AUD, underscoring the scale of the public health burden. (SAMHSA) Despite this prevalence, only a small fraction receive evidence-based medication treatment, due to limited efficacy, tolerability, and real-world appeal of current options. (Pew)

“Baseline has the team, infrastructure, and clinical network required to deliver a high-quality pivotal program in AUD,” said Nicholas Reville, CEO and Co-Founder. “We are prioritizing execution: an FDA-aligned Phase 3 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.”

Differentiators

• Phase 3 pathway for BT-001 in AUD aligned with FDA expectations, with trial-start targeted for Q2 2026.
• Once-weekly dosing intended to improve adherence and usability versus existing pharmacotherapy options in AUD.
• Strong scientific leadership from Morris Birnbaum, MD, PhD, a global leader in incretin and metabolic biology.
• Expansion plans for BT-001 in additional substance use disorder indications, including stimulant and opioid use disorders.

About Baseline Therapeutics

Baseline Therapeutics, Inc. (baseline-tx.com) is a San Francisco-based clinical-stage biotechnology company developing breakthrough therapeutics for addiction. Baseline’s lead program, BT-001, is a once-weekly GLP-1 receptor agonist candidate being developed for alcohol use disorder and additional substance use disorder indications.

Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Baseline’s plans to initiate and conduct clinical trials; the timing, design, and outcomes of clinical studies; potential therapeutic and commercial benefits of BT-001; and planned expansion into additional indications. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including clinical development risks, regulatory developments, trial initiation and enrollment timelines, manufacturing and supply risks, and other factors.

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Baseline plans to initiate two randomized, placebo-controlled Phase 3 studies of BT-001 in AUD in 2026, supported by an FDA-aligned development pathway.