Pilot clinical drug trial for treatment of infantile spasms

November 9, 2021
Pilot clinical drug trial for treatment of infantile spasms

The first patient in an AC-21-024 study, a pilot clinical trial of tricaprilin for the treatment of Infantile Spasms, has been enrolled by Cerecin, a clinical-stage biotechnology company developing ketogenic agents as potential neurotherapeutics.

Tricaprilin is an investigational oral drug under development for several neurological conditions, including migraine and epilepsy, and is designed to induce ketosis. In October 2020, Cerecin received Rare Pediatric Disease Designation and Orphan Drug Designation for tricaprilin in Infantile Spasms from the US Food and Drug Administration.

The AC-21-024 clinical trial investigates the feasibility, safety, tolerability, and efficacy of daily administration of tricaprilin in participants with Infantile Spasms. The study is being conducted at leading institutions for pediatric epilepsy in Australia and Singapore and results are expected in late 2022.

Dr. Judith Walker, Cerecin’s Chief Medical Officer, said “Infantile Spasms is a serious condition, and is frequently neglected by biopharma companies. Infantile Spasms is seen in around 1 in every 3,000 infants globally and has unmet clinical needs. We are optimistic about the potential of tricaprilin as a treatment for this devastating epileptic condition of childhood.”

Infantile Spasms (IS) is a pediatric epileptic condition characterized by epileptic spasms, an abnormal brain wave pattern called hypsarrhythmia, and developmental delay, presenting in infancy. It is commonly treated with ACTH and vigabatrin, as well as a ketogenic diet.

Cerecin is a biopharmaceutical company focused on the discovery and development of drugs to treat and prevent diseases of the brain. Cerecin’s development programmes leverage its extensive experience in lipid science to explore the potential therapeutic benefits of ketogenic drugs and other compounds in a variety of conditions.

Cerecin is led by an expert executive management team with strong global expertise in central nervous system drug development and is supported by two partners, Nestlé, and Wilmar, one of the world’s leading manufacturers of fatty acids and lipids. In addition to the AC-21-024 study of tricaprilin in Infantile Spasms, Cerecin is currently conducting study AC-20-022 of tricaprilin in migraine prevention (NCT04437199 (The RELIEF trial).

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Category: Features, Pharmaceuticals

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