Solaxa, Inc.
Solaxa is a clinical-stage biopharmaceutical company dedicated to developing treatments for rare neurodegenerative diseases and nerve injuries. They focus on restoring nerve function by targeting ion channels, with a mission to improve patient outcomes through impactful and accessible therapies. The company is organized as a public benefit corporation, emphasizing societal health alongside profitability.
Industries
Nr. of Employees
small (1-50)
Solaxa, Inc.
7272 Wisconsin Ave 9th floor Bethesda, MD 20814
Products
Investigational reformulated aminopyridine therapy for spinocerebellar ataxia (registrational candidate)
A reformulated aminopyridine-class small molecule developed to address ion channel dysfunction in spinocerebellar ataxia; advanced to IND-cleared clinical studies and planned for registrational Phase 3 evaluation.
Pharmacologic diagnostic application for peripheral nerve injury assessment
Clinical application under study using an ion channel–blocking small molecule to transiently restore function in non-severed peripheral nerves, enabling early differentiation between severed and recoverable injuries.
Investigational reformulated aminopyridine therapy for spinocerebellar ataxia (registrational candidate)
A reformulated aminopyridine-class small molecule developed to address ion channel dysfunction in spinocerebellar ataxia; advanced to IND-cleared clinical studies and planned for registrational Phase 3 evaluation.
Pharmacologic diagnostic application for peripheral nerve injury assessment
Clinical application under study using an ion channel–blocking small molecule to transiently restore function in non-severed peripheral nerves, enabling early differentiation between severed and recoverable injuries.
Services
Acting as regulatory sponsor for human studies, coordinating trial setup with clinical sites and centers of expertise for registrational studies.
Funding and management of sponsored research agreements with disease foundations to expand natural history cohorts and support diagnostic/genetic testing programs.
Development activities encompassing reformulation and clinical evaluation of ion channel–targeting small molecules for neurological indications.
Securing and managing non-dilutive grants and public investments to support research and development activities.
Acting as regulatory sponsor for human studies, coordinating trial setup with clinical sites and centers of expertise for registrational studies.
Funding and management of sponsored research agreements with disease foundations to expand natural history cohorts and support diagnostic/genetic testing programs.
Development activities encompassing reformulation and clinical evaluation of ion channel–targeting small molecules for neurological indications.
Securing and managing non-dilutive grants and public investments to support research and development activities.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions (IND, orphan designation)
- Rare disease drug development
- Neuropharmacology and ion channel therapeutics
Key Technologies
- Small-molecule ion channel modulators
- Aminopyridine-class therapeutics
- Drug repurposing methodologies
- Registrational clinical trial design
News & Updates
Solaxa announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B). The trial will be funded in part by a $7.3 million grant awarded to Dr. Susan Perlman at UCLA. The company will serve as the regulatory sponsor and partner with ataxia centers of excellence.
Solaxa announced that the FDA has provided formal clearance of its IND application to proceed with human clinical studies for SLX-100, a treatment for spinocerebellar ataxia. The company received regulatory feedback supporting the use of the Section 505(b)(2) pathway and orphan drug designation.
Solaxa signed a sponsored research agreement with the National Ataxia Foundation to pursue treatment options for patients with Spinocerebellar Ataxia Type 27B (SCA27b). The collaboration includes joining the NAF Drug Development Collaborative, expanding natural history studies, and supporting genetic testing programs.
Solaxa announced the appointment of Dr. Amy Chappell as Chief Medical Officer. The company also appointed Kerry Clem as Chief Commercial Officer, who has extensive experience in neurodegenerative disease treatments and drug commercialization.
The FDA granted orphan drug designation to Solaxa Inc. for its investigational therapy, SLX-100, for the treatment of spinocerebellar ataxia.
Solaxa announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B). The trial will be funded in part by a $7.3 million grant awarded to Dr. Susan Perlman at UCLA. The company will serve as the regulatory sponsor and partner with ataxia centers of excellence.
Solaxa announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B). The trial will be funded in part by a $7.3 million grant awarded to Dr. Susan Perlman at UCLA. The company will serve as the regulatory sponsor and partner with ataxia centers of excellence.
Solaxa announced that the FDA has provided formal clearance of its IND application to proceed with human clinical studies for SLX-100, a treatment for spinocerebellar ataxia. The company received regulatory feedback supporting the use of the Section 505(b)(2) pathway and orphan drug designation.
Solaxa signed a sponsored research agreement with the National Ataxia Foundation to pursue treatment options for patients with Spinocerebellar Ataxia Type 27B (SCA27b). The collaboration includes joining the NAF Drug Development Collaborative, expanding natural history studies, and supporting genetic testing programs.
Solaxa announced the appointment of Dr. Amy Chappell as Chief Medical Officer. The company also appointed Kerry Clem as Chief Commercial Officer, who has extensive experience in neurodegenerative disease treatments and drug commercialization.
The FDA granted orphan drug designation to Solaxa Inc. for its investigational therapy, SLX-100, for the treatment of spinocerebellar ataxia.
Solaxa announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B). The trial will be funded in part by a $7.3 million grant awarded to Dr. Susan Perlman at UCLA. The company will serve as the regulatory sponsor and partner with ataxia centers of excellence.