Newleos raises $93.5m for neuropsychiatric therapies

Newleos Therapeutics has successfully closed a robust Series A financing round, accumulating $93.5 million to advance the treatment landscape for neuropsychiatric disorders with innovative medications. The funding initiative, led by Goldman Sachs Alternatives, also saw significant contributions from Longwood Fund, Novo Holdings, Arkin Bio Ventures, and DCVC Bio.

The company has acquired a clinical-stage pipeline from Roche, which includes several oral small molecule candidates showcasing new mechanisms of action. These candidates aim to address a spectrum of conditions, including generalised anxiety, social anxiety, cognitive impairment, and substance use disorders. To secure global rights to these clinical assets, Newleos has made an upfront payment and committed to performance-based milestones and royalty payments.

David Donabedian, the founding CEO of Newleos and executive partner at Longwood Fund, highlighted the critical need for innovative treatments in anxiety and substance use disorders. These conditions are among the most common neuropsychiatric indications, affecting over 60 million individuals in the United States and accounting for more than 25% of mental illnesses in adults. Donabedian emphasized that with a seasoned team well-versed in company creation and the development of central nervous system drugs, Newleos is poised to utilize this capital influx to conduct proof-of-concept clinical trials across its programs.

At the forefront of Newleos' clinical efforts is NTX-1955, an innovative gamma-aminobutyric acid type A (GABAA)-γ1 selective positive allosteric modulator (PAM). This candidate is designed to treat anxiety disorders with a distinctive mechanism that seeks to circumvent the adverse effects commonly associated with existing treatments. By specifically targeting anxiety, NTX-1955 aims to avoid engaging other brain networks that may pose safety concerns.

NTX-1955 has already been through a comprehensive non-clinical package and Phase I trials, which included studies on single and multiple ascending doses, drug-drug interactions, and receptor occupancy. The therapy has demonstrated safety, tolerability, brain penetration, and selectivity for the GABAA-γ1 receptor. Newleos is preparing to further explore this candidate in proof-of-concept clinical trials specifically for generalised anxiety disorder.

In addition to NTX-1955, Newleos has several other promising clinical-stage assets. These include NTX-1472, NTX-2001, and NTX-1511, which are designed to target the V1a, TAAR1, and GABAA-α5 receptors, respectively. Each of these candidates represents a potential new approach to managing neuropsychiatric conditions, continuing Newleos' mission to deliver groundbreaking treatments for patients with unmet medical needs.