Calico Life Sciences said its experimental therapy for an autosomal recessive brain disorder has been tapped for the FDA’s Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot programme. It's the seventh and final candidate to be announced for the new initiative, which is intended to speed up the development of mid- to late-stage drugs and biologics for rare diseases by enabling more frequent communication with the US regulator.
"The inclusion of fosigotifator underscores the potential of this investigational therapy in addressing the unmet needs of individuals and families affected by vanishing white matter disease," said Calico CEO Arthur Levinson.
Participating therapies in the pilot programme are split between drugs and biologics, with FDA’s Center for Drug Evaluation and Research (CDER) having selected three products for rare neurodegenerative conditions, and the regulator’s Center for Biologics Evaluation and Research (CBER) having picked four cell or gene therapies intended to treat a rare disease that is likely to lead to significant disability or death within the first decade of life.