Annexon Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its novel C1q inhibitor, ANX005, to treat Guillain-Barré Syndrome (GBS).
GBS is a rare, acute and antibody-mediated autoimmune disease that will affect the peripheral nervous system. The disease currently has no approved therapies in the US.
Earlier, the company secured orphan drug designation from the FDA for ANX005 to treat GBS.
ANX005 is a clinical-stage investigational monoclonal antibody designed for the treatment of patients suffering from autoimmune and neurodegenerative disorders.
The novel therapy, which is formulated for intravenous administration, is designed to block C1q and the complete classical complement pathway.
The company has completed a phase 1b clinical study of ANX005 and intends to advance ANX005 into later-stage clinical trials in GBS disease.
Annexon is also planning to develop ANX005 for additional autoimmune and neurodegenerative diseases.
GBS is typically generated by a preceding infection and generally involves rapidly progressive weakness in the limbs that may terminate within four weeks to widespread peripheral nerve damage and paralysis.
According to the company, GBS was estimated to affect 0.8 to 1.9 per 100,000 persons in North America and Europe per annum in 2011.
Annexon Biosciences president and CEO Doug Love said: “Fast Track designation is a testament to the urgent need for a new therapy to treat patients with GBS, as there are no FDA-approved therapies for this debilitating neurological disease.
“Having completed our Phase 1b clinical trial in patients with GBS, we look forward to advancing ANX005 into later- stage clinical trials. Our goal is to bring ANX005 to patients with GBS as quickly as possible.”
Annexon is a clinical-stage biopharmaceutical company involved in the development of novel therapies to treat patients with classical complement-mediated disorders of the body, eye and brain.