, /PRNewswire/ -- Calico Life Sciences LLC (Calico), a biotechnology organization focused on the biology of aging and age-related diseases, and founded by Alphabet and , Ph.D., today announced that its investigational eIF2B activator fosigotifator (ABBV-CLS-7262) has been accepted into the U.
S. Food and Drug Administration (FDA) Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. Fosigotifator is being developed by Calico and AbbVie pursuant to their 2014 collaboration as a potential treatment for Vanishing White Matter (VWM) disease.
FDA's Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) initiated the to help further accelerate the development of novel drug and biological products for rare diseases. Selected participants will be able to obtain frequent advice and enhanced communication with FDA review staff to address program-specific development issues, including, but not limited, to clinical study design, choice of control group, and fine-tuning the choice of patient population. "Calico is honored that fosigotifator has been selected by CDER as one of three candidates for the FDA's innovative START Pilot Program.
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 , Ph.D., founder and CEO of Calico.
"We applaud the FDA's dedication to advancin.
