Federico Bolognani, M.D., Ph.D.
Co-founder
Newleos
Newleos Therapeutics is a clinical‑stage biotech developing oral small‑molecule drugs that target novel neuropsychiatric pathways, aiming to treat generalized anxiety, social anxiety, alcohol use disorder, and cognitive impairment with fewer side effects. Its pipeline includes a GABAA‑γ1 positive allosteric modulator and a vasopressin‑1a receptor antagonist, both designed for improved efficacy and safety compared to existing therapies.
- Biotechnology
Updated 5 months ago
Funding
Raised to date
$93.5MRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Funding rounds are not available yet.
Founders
William Martin, Ph.D.
Co-founder
Product
Problem
Millions of individuals with anxiety, social anxiety, substance use disorders, and cognitive impairment receive treatments that are either ineffective for a large subset of patients or cause significant side effects such as sedation, dependence, cognitive decline, or sexual dysfunction. The lack of mechanistically novel, orally administered therapies limits therapeutic options and contributes to persistent unmet clinical need.
Solution
Newleos Therapeutics is a clinical‑stage biotechnology company developing oral small‑molecule drugs that target distinct neuropsychiatric pathways to improve efficacy while reducing adverse effects. Its pipeline includes NTX‑1955, a GABAA‑γ1 positive allosteric modulator designed to selectively enhance inhibition in the amygdala for generalized anxiety disorder, and NTX‑1472, a highly selective vasopressin‑1a receptor antagonist aimed at treating social anxiety disorder. Additional candidates such as NTX‑2001 target alcohol use disorder, and other molecules address cognitive impairment. By focusing on first‑ or best‑in‑class mechanisms, Newleos seeks to provide safer, more effective oral therapies that can be integrated into existing treatment regimens for major neuropsychiatric conditions.
Target Audience
Primary customers are pharmaceutical companies and healthcare providers seeking novel oral treatments for generalized anxiety disorder, social anxiety disorder, alcohol use disorder, and related neuropsychiatric conditions.
Features
- Oral small‑molecule GABAA‑γ1 positive allosteric modulator (NTX‑1955) that preferentially engages amygdala circuits to reduce anxiety without the sedation and dependence associated with non‑selective benzodiazepines
- Highly selective vasopressin‑1a receptor antagonist (NTX‑1472) that modulates social threat processing pathways, offering a novel mechanism for social anxiety disorder
- Clinical‑stage development with Phase 1b proof‑of‑mechanism studies for NTX‑1955 and Phase 2 SOAR trial for NTX‑1472, demonstrating safety, brain penetration, and target engagement
- Additional pipeline candidates (e.g., NTX‑2001) addressing alcohol use disorder and cognitive impairment, expanding therapeutic coverage across high‑need neuropsychiatric indications
- Proprietary chemistry and pharmacology platform licensed from Roche, enabling rapid progression of innovative mechanisms of action