Cerecin, a biotechnology company that develops neurotherapeutics has presented its findings from a recent study of CER-0001 (tricaprilin), an investigational ketogenic agent. The results show that people who experience migraines might benefit from the treatment. The data will inform future studies.
The findings were presented at the 65th Annual Society Meeting of the American Headache Society, held in Austin, Texas from 15-18 June 2023, in a poster presentation by Singapore-based Cerecin’s chief medical officer, Dr Marc Cantillon.
In 2021, Cerecin appointed the clinical research organisation, Australia-based Novotech, for its Phase II tricaprilin trial.
The RELIEF study (NCT04437199) was a double-blind, randomised, placebo-controlled, 3-month study of up to 60g/day tricaprilin. The primary endpoint was the change from baseline in the number of migraine headache days (MHDs) during month three. This was not met due to a lack of statistical power, but an efficacy signal was noted in sensitivity analysis.
Eligible participants had 4-24 MHDs in the baseline period. Some patients chose to enter the CER-0001 compassionate access program, which allows access to tricaprilin for up to one year after completion of the clinical trial.
Metabolic factors have been implicated in migraine. In patients with migraine, the brain presents an energy deficit compared to healthy subjects. Ketogenesis provides an alternative and efficient fuel source and may restore this metabolic imbalance.
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Some research suggests a ketogenic diet could offer some relief. Therefore, encouraging the body to enter ketosis using ketogenic drugs offers promise to sufferers of migraines.
According to GlobalData, global sales for migraine drugs were valued at $4.6bn in 2020 with a compound annual growth rate of over 9%. In 2021, the US dominated the migraine market, contributing to more than 80% of the sales in the seven major pharmaceutical markets (7MM) covered – the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan.
A high market share in the US is attributed to the large migraine prevalent population, the costliness of branded drugs, and the number of drugs marketed exclusively in the US compared to other countries in the 7MM.