Newleos Therapeutics, Inc., a Boston, MA-based clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, closed $93.5m Series A financing.
The round was led by Goldman Sachs Alternatives with participation from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital.
Co-founded by Longwood Fund, Federico Bolognani, M.D., Ph.D., and William Martin, Ph.D., and led by David Donabedian, Ph.D., Founding CEO, Newleos has a clinical-stage pipeline that was in-licensed from Roche which includes multiple oral small molecules targeting novel mechanisms across a broad range of indications including generalized anxiety, social anxiety, substance use disorders and cognitive impairment.
Its lead clinical program, NTX-1955 (RO7308480), is a first-in-class GABAA-γ1 selective positive allosteric modulator (PAM) designed to treat anxiety disorders with a differentiated mechanism of action without the side effects of currently available treatments. NTX-1955 was designed to specifically modulate GABAergic transmission in the anxiety brain circuit by targeting the γ1 (gamma-1) subunit-containing GABAA receptor, which is highly enriched in the amygdala. By focusing on GABAA regulation in the amygdala, NTX-1955 has the potential to reduce anxiety while sparing other brain networks associated with safety liabilities. NTX-1955 has completed a comprehensive non-clinical package and has been in Phase 1 trials, including single and multiple ascending dose studies, drug-drug interaction and receptor occupancy studies, demonstrating that it is safe, well tolerated, brain penetrant and selective to GABAA-γ1. Newleos plans to investigate NTX-1955 in proof-of-concept clinical studies for the treatment of generalized anxiety disorder.
Newleos’ additional clinical-stage assets include NTX-1472 (RO6953958), NTX-2001 (ralmitaront), and NTX-1511 (basmisanil), which target V1a, TAAR1 and GABAA-α5 receptors, respectively. NTX-1472 is a selective, brain-penetrant V1a antagonist poised to enter proof-of-concept studies targeting social anxiety disorder. A well-understood pathway, the V1a receptor is activated by arginine vasopressin (AVP), a nanopeptide structurally related to oxytocin. Preclinical studies have shown that blocking V1a reduces anxiety-like behavior in multiple animal models. NTX-2001 is a TAAR1 partial agonist, which Newleos intends to study in substance use disorders. TAAR1 activation inhibits the rewarding and reinforcing effects of drugs from different classes including psychostimulants, opioids and alcohol. NTX-1511 is a highly selective negative allosteric modulator (NAM) of the α5 (alpha-5) subunit of the GABAA receptor with the potential to address cognitive impairment in rare-neurodevelopmental indications.
The Newleos Board of Directors includes Christoph Westphal, M.D., Ph.D., Founding Executive Chairman, Newleos Therapeutics and Founding Partner, Longwood Fund; Ming Cheah, Ph.D. Vice President, within Life Sciences Investing at Goldman Sachs Alternatives; Ray Camahort, Ph.D., Partner in the Venture Investments group at Novo Holdings US; and David Donabedian, Ph.D., Executive Partner, Longwood Fund, and Founding CEO, Newleos. As part of the licensing agreement, Roche received an upfront payment and is eligible to receive success-based milestones and royalties in exchange for granting Newleos worldwide rights to the clinical stage assets.
FinSMEs
13/02/2025