Neuron23 Begins Phase 1 Trial of NEU-111 TYK2 Inhibitor for Immune Disorders

SOUTH SAN FRANCISCO, Calif.--Neuron23 Inc., a biotechnology firm at the clinical stage, has recently commenced dosing in a Phase 1 clinical trial of NEU-111, involving healthy volunteers. NEU-111 is an oral allosteric inhibitor of tyrosine kinase 2 (TYK2), a protein that belongs to the JAK family, essential for immune signaling.

Dr. Nancy Stagliano, CEO of Neuron23, expressed excitement about introducing NEU-111 to the clinic, highlighting its potential as a leading molecule. She emphasized the significance of TYK2 as a validated target, noting the FDA's approval of TYK2 inhibitors for psoriasis, which underscores its crucial role in modulating immune signaling pathways. Stagliano pointed out that NEU-111 could be transformative for individuals with various immune-related conditions by providing almost complete inhibition of TYK2 with a minimal, once-daily dose. She believes that NEU-111 could offer new treatment possibilities and foster partnerships as Neuron23 continues to expand its portfolio of next-generation therapies for neurological and immunological disorders.

The current Phase 1 trial (NCT06500442) is a randomized, double-blind, placebo-controlled study with both single-ascending and multiple-ascending dose phases. It aims to assess the safety, tolerability, and pharmacokinetics of NEU-111 in healthy adult volunteers.

NEU-111 is distinguished as a highly selective oral allosteric TYK2 inhibitor believed to have best-in-class potential. It curtails signaling through various cytokine receptors, including those for interleukin (IL)-12, IL-23, and interferon (IFN)-a. Preclinical studies indicate that NEU-111 can achieve nearly complete TYK2 inhibition with a low, once-daily dose. Given TYK2's pivotal function in both innate and adaptive immune responses, it is associated with numerous immune-mediated inflammatory conditions. These include inflammatory bowel diseases like ulcerative colitis and Crohn’s disease; systemic lupus erythematosus; polyarthropathies such as rheumatoid arthritis and ankylosing spondylitis; and Type 1 diabetes.

Neuron23 Inc. is dedicated to developing precision medicines for genetically defined neurological and immunological diseases. Utilizing the latest advancements in human genetics, combined with a cutting-edge drug discovery and biomarker platform that leverages machine learning and artificial intelligence, Neuron23 aims to advance treatments for severe diseases. The company focuses on neurodegenerative and neuroinflammatory diseases, as well as systemic autoimmune and inflammatory conditions. With its foundation in 2018, Neuron23 has built a team of leading experts and entrepreneurs based in South San Francisco, California.