Calico Life Sciences LLC, a leading biotechnology company, has announced that fosigotifator (ABBV-CLS-7262), its investigational eIF2B activator for the treatment of Vanishing White Matter Disease, has been accepted into the U.S. Food and Drug Administration (FDA) Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.
The FDA’s START Pilot Program aims to facilitate and expedite the development and review of new drugs intended to treat rare diseases. By participating in this program, Calico Life Sciences will receive additional support and guidance from the FDA throughout the clinical trial process, potentially accelerating the development of fosigotifator as a groundbreaking therapy for patients with Vanishing White Matter Disease.
Vanishing White Matter Disease is a rare, autosomal recessive disorder that primarily affects the central nervous system, leading to progressive neurological deterioration. Currently, there are no approved treatments for this devastating condition. Fosigotifator, an eIF2B activator, represents a promising therapeutic approach by targeting the underlying molecular mechanisms of the disease.
