Cerecin Enrolls First Patient in a Phase 2 Pilot Clinical Trial of Tricaprilin for Migraine Prevention (the Relief Study)


Colorado, USA and Melbourne, Australia, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Cerecin, a biopharmaceutical company focused on brain therapeutics, announced the enrollment of the first patient in its Relief Study, a Phase 2 clinical trial of tricaprilin for migraine prevention.

Tricaprilin is an investigational oral drug under development, which has been designed to induce ketosis and improve mitochondrial metabolism.

The study is designed as a two-part, 12-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the safety and efficacy of daily administration of tricaprilin in patients with migraine. Part 1 of the study is a pilot, and will recruit 66 patients. The first randomized patient was screened and approved for the study today.

The study is being conducted exclusively in Australia, with Dr. Elspeth Hutton from the Department of Neuroscience at Monash University as lead investigator.  Dr. Hutton is a specialist neurologist and head of the Headache and Neuromuscular Services at Alfred Health.

The study will be conducted across 9 clinical sites: NeuroCentrix (Noble Park), Alfred Health (Melbourne), Gold Coast University Hospital (Southport), Paratus Clinical Research Central Coast (Kanwal), Paratus Clinical Research Western Sydney (Blacktown), Centre for Neuroscience Innovation (Calvary Adelaide Hospital), Holdsworth House (Sydney), Emeritus Research (Camberwell) and Austin Health (Melbourne).

Dr Judith Walker, Chief Medical Officer at Cerecin said “Migraine is a hidden epidemic affecting 4.9 million Australians and a billion people worldwide, and it currently has no cure. We are looking forward to investigating the potential of tricaprilin to benefit people living with migraine.”

“Researchers have made significant advancements in the study of migraines and enhancing our understanding of the role of metabolic dysfunction, is an important part of the puzzle,” said Dr Hutton. Part 1 of the study is designed to provide a preliminary assessment of safety, tolerability and clinical effects of tricaprilin in migraine patients. Results for Part 1 are expected in late 2021.

For more information on the Relief study see www.clinicaltrials.gov, identifier NCT04437199.

About Cerecin 

Cerecin is a biopharmaceutical company focused on the discovery and development of drugs to treat diseases of the brain. Cerecin’s development program leverages its extensive experience in lipid science to explore the potential therapeutic benefits of medium-chain triglycerides. 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 fatty acids and lipids. Bringing together the deep industry expertise of its leadership team, and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

About tricaprilin (CER-0001)

Tricaprilin, also known as CER-0001, is a specific medium chain triglyceride that Cerecin is developing for a range of neurological indications including Alzheimer’s disease, migraine and infantile spasms. Tricaprilin is a ketogenic compound that elevates plasma ketone levels and is thereby intended to leverage the numerous activities and benefits of ketone bodies.

For further information, please contact: 

Thomas Harding/Khushboo Tanna 

cerecin@spurwingcomms.com 

© 2020 Cerecin AC-20-897 12/20