Solaxa Inc. Announces FDA Clearance of IND Application for SLX-100
Bethesda, MD; January 6, 2024 – Solaxa Inc. announces today that the U.S. Food and Drug Administration (FDA) has provided formal clearance of the company’s Investigational New Drug (IND) application to proceed with human clinical studies to evaluate SLX-100. Solaxa is developing SLX-100 as a treatment for patients with spinocerebellar ataxia (SCA).
In April 2024, Solaxa received written regulatory pre-IND feedback from the FDA that the Section 505(b)(2) pathway is appropriate for SLX-100 as are the specific clinical endpoints and study design that Solaxa proposed. FDA subsequently granted Solaxa’s application for orphan drug designation (ODD) for the treatment of SCA in July 2024.
Solaxa’s Founder and CEO, Christian Walker, stated, “We are grateful for the FDA’s clearance to begin clinical trials with SLX-100, which we believe will become a standard treatment for spinocerebellar ataxia. Entering the clinical stage is a significant milestone for the organization, and we’re excited to advance our uniquely formulated dalfampridine to address the specific needs of people with spinocerebellar ataxia.”
About Solaxa
Solaxa is a clinical-stage biopharmaceutical public benefit corporation developing treatments that restore nerve function in patients with rare neurodegenerative diseases and acute nerve injuries. The company is developing a class of aminopyridine drugs that both detect and treat ion channel dysfunction. Solaxa’s public benefit mission is to advance scientific knowledge and deliver impactful and accessible therapies that improve outcomes for patients worldwide. For more information, visit Solaxa.com.
CONTACT:
Luis Gutierrez, COO
Solaxa Inc.