09.03.2025
Neusignal Therapeutics (CEO: Yoshifumi Yoshida; Headquarters: Tokyo, Japan; hereinafter referred to as “NTX”), a clinical-stage biotechnology company developing novel therapies for Alzheimer’s disease, has completed dosing and evaluation in its first-in-human clinical study of NTX-083 in healthy adult participants. The study was conducted as an investigator-initiated trial at the University of Tokyo Hospital, with first dosing initiated on February 18, 2025.
NTX-083 is a small molecule inhibitor targeting K-ATP channels, under development as a potential treatment for Alzheimer’s disease. The completed study evaluated the safety, tolerability, and pharmacokinetics of NTX-083 following single-dose administration. All planned dosing and safety assessments were completed as scheduled.
Based on these results, NTX plans to initiate a company-sponsored, repeat-dose Phase 1 clinical trial in healthy volunteers. In parallel, the company is preparing for a Phase 1b trial in the U.S. in patients with Alzheimer’s disease.
FTI continues to support NTX across R&D, strategic planning, and business development as the company advances NTX-083 toward clinical validation and future global expansion.
About Neusignal Therapeutics
Neusignal Therapeutics is a pioneering biotechnology company based in Tokyo, Japan, focused on the development of innovative therapies for Alzheimer’s disease. Founded as a spin-off from Tohoku University, Neusignal is dedicated to advancing novel drug candidates aimed at slowing the progression of Alzheimer’s, a condition that is rapidly increasing worldwide. With a commitment to addressing the complex challenges of treatment management, high healthcare costs, and patient eligibility, Neusignal strives to bring transformative solutions to those affected by Alzheimer’s. The company is preparing for clinical trials, with plans for both domestic and international development.
About Fast Track Initiative:
Established in 2004, Fast Track Initiative, Inc. (FTI) is a life science venture capital firm focusing its investments on early-stage startups with a strong focus on biotech and therapeutics. FTI has a strict mission to make a ground-breaking impact on the quality of our life and human wellness through investments across a broad range of areas in the life science community including therapeutics, diagnostics, digital health, healthcare services, and more. The company provides valuable, hands-on support to its 30+ portfolio companies through business and R&D strategy, partnering, investor syndication, and more, including access to its network of professionals in Japan.
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