October 31, 2022

Loulou Foundation Announces First-Patient-In for CANDID Observational Study on CDKL5 Deficiency Disorder

Article published by Business Wire

The Loulou Foundation, a private foundation dedicated to the development of therapeutics for the neurodevelopmental condition CDKL5 Deficiency Disorder (CDD), announced today that the first patient has been enrolled in the three-year observational study with CDD patients, the Clinical Assessment of NeuroDevelopmental measures In CDD (CANDID) study. The CANDID study is directed by a novel consortium of seven biopharmaceutical industry partners, together with the Loulou Foundation, to enable the development of disease-modifying therapeutics for CDD.

The CANDID study will investigate the baseline and longitudinal performance of known and validated instruments and scales, measuring cognitive, motor, and developmental domains in up to 100 CDD patients. The CANDID study was the subject of a Critical Path Innovation Meeting with the U.S. Food and Drug Administration in December of 2020. The study design incorporates input from the agency. More information on the CANDID study can be found here.

“This first CDD patient enrollment in the CANDID study is an exciting milestone and a landmark first step in the development of disease-modifying therapeutics to treat this devastating disorder. The Loulou Foundation and our pre-competitive consortium partners are grateful for the sacrifices made by our CDKL5 community families participating in this observational study, which will be invaluable in moving forward therapies that go beyond management of seizures,” said Xavier Liogier, Ph.D., Chief of Translational Science at the Loulou Foundation.