Newleos Therapeutics—a clinical-stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development—announced the closing of an oversubscribed $93.5 million Series A financing. Goldman Sachs Alternatives led the funding, which was participated in by Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital.
Newleos’ clinical-stage pipeline was in-licensed from Roche and 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.
Newleos’ lead clinical program NTX-1955 (RO7308480), is a first-in-class GABAA-γ1 selective positive allosteric modulator (PAM) designed for treating 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. And 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.
The 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.
KEY QUOTES:
“Anxiety and substance use disorders represent some of the most prevalent neuropsychiatric indications with high unmet need, representing over 25 percent of mental illnesses in US adults and impacting over 60 million individuals. With a seasoned, founding team that has extensive company creation and CNS drug development experience, Newleos will use this capital to conduct proof-of-concept clinical trials across our programs.”
– David Donabedian, Ph.D., Founding CEO, Newleos and Executive Partner, Longwood Fund
“The Partners at Longwood Fund have long recognized that currently available treatments fall short of meeting the needs of patients with mental health conditions. A majority of anxiety patients fail to respond to first line therapy with SSRIs and SNRIs, and benzodiazepines are not recommended for long term use due to side effects such as sedation, potential for misuse and dependence, and cognitive decline. Newleos’ portfolio of clinical stage candidates provides an exciting opportunity to advance truly differentiated medicines for some of the most prevalent indications like anxiety and substance use disorders.”
– Dr. Westphal
“We believe the field of neuropsychiatry is going through a period of robust innovation, with the potential to dramatically improve outcomes for patients. We are pleased to lead the Series A for Newleos as a differentiated opportunity to invest in an attractive portfolio of clinical-stage programs that may deliver meaningful benefit to the lives of patients with underserved neuropsychiatric disorders. We look forward to partnering with the Newleos team to advance its pipeline of novel therapeutics.”
– Dr. Cheah
“Novo Holdings is committed to advancing innovative solutions for neurological and psychiatric conditions, a therapeutic area that urgently needs best-in-class and novel first-in-class therapies that could meaningfully improve patient outcomes. We believe Newleos’ pipeline has the potential to advance the treatment of neuropsychiatric diseases across multiple indications and Novo Holdings is excited to support the Newleos team on this journey to bring much needed novel medicines to patients with neuropsychiatric disorders.”
– Dr. Camahort
