AbbVie and Alphabet’s Calico announced Friday that their potential treatment for the rare neurological disease known as vanishing white matter disease will be part of the FDA’s new Operation Warp Speed for rare diseases.
The companies’ investigational eIF2B activator fosigotifator is the seventh development program to participate in the pilot, known officially as Support for clinical Trials Advancing Rare disease Therapeutics (START). Moderna’s mRNA therapy, Denali Therapeutics’ enzyme replacement therapy and four others from Larimar Therapeutics, Grace Science, Neurogene and Myrtelle were also selected for the pilot and unveiled this week.
Calico and AbbVie are conducting a Phase 1b/2 trial of fosigotifator to study its safety, tolerability and pharmacokinetics in VWM disease. The companies said this study is the first time an eIF2B activator has been administered to people with the disease.
Fosigotifator is the result of the pact formed between Calico and AbbVie in 2014 with each investing $250 million initially. The potential therapy is similar to others participating in the START pilot because it addresses a disease that has no available treatments.
Arthur Levinson, founder and CEO of Calico, said in a statement that the inclusion of fosigotifator in START “underscores the potential of this investigational therapy in addressing the unmet needs of individuals and families affected by Vanishing White Matter Disease.”