BOSTON — Newleos Therapeutics, a biotechnology firm focused on neuropsychiatric treatments, has appointed Dr. Stephen Brannan, a veteran in neuroscience and psychiatric drug development, to its Board of Directors. The announcement comes as the company begins Phase 1b clinical trials in Europe for NTX-1955, its investigational therapy for generalized anxiety disorder (GAD).
Brannan most recently served as Chief Medical Officer at Karuna Therapeutics, where he led the clinical development of KarXT — the first novel schizophrenia treatment mechanism to gain U.S. FDA approval in over three decades. Karuna was acquired by Bristol Myers Squibb in 2024 for $14 billion. His experience includes senior roles at Takeda, Forum Pharmaceuticals, Novartis, Cyberonics, and Eli Lilly, and involvement in the development of CNS drugs such as Cymbalta, Exelon Patch, Trintellix, and VNS therapy for depression.
“We are thrilled to welcome Steve to the Newleos Board of Directors,” said David Donabedian, Ph.D., CEO and founding executive of Newleos. “His leadership in designing and executing neuroscience drug trials will be invaluable as we advance NTX-1955 and other programs in our pipeline.”
Brannan expressed enthusiasm about joining the company. “The team’s patient focus and scientific rigor is clear, and I believe their innovative approach to targeting neuropsychiatric disorders has strong potential to address major unmet needs in the field,” he said.
Alongside the board appointment, Newleos announced it has filed clinical trial applications in the EU for two Phase 1b studies of NTX-1955. One study has already begun dosing participants. Both will use validated models to assess the drug’s anxiolytic and broader central nervous system effects.
“There remains a profound unmet need for safe, effective, and fast-acting treatments for generalized anxiety disorder,” said Federico Bolognani, M.D., Ph.D., co-founder and Chief Medical Officer of Newleos. “NTX-1955 takes a fundamentally different approach by selectively modulating GABAA-γ1 receptors, aiming to deliver the benefits of GABAergic therapy without the risks associated with benzodiazepines.”
The company said these early studies will build on the compound’s existing safety profile and mark a critical step toward validating its novel mechanism in humans.
