Clinical Trial Data of Novel Metabolic Mechanism in Migraine: CER-0001, a Ketogenic Investigational Agent

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01 Jul, 2023, 00:52 CST

A poster showcasing data from the RELIEF study of CER-0001 (tricaprilin), being investigated for the preventive treatment of migraine, was presented at the 65th Annual Society Meeting of the American Headache Society
Data from the pilot study, showed a positive efficacy signal and supports advancement of CER-0001 into pivotal studies
The poster was presented by Cerecin's Chief Medical Officer, Dr Marc Cantillon

DENVER and SINGAPORE, July 1, 2023 /PRNewswire/ -- Cerecin Inc., a clinical-stage biotechnology company at the forefront of developing innovative neurotherapeutics, presented encouraging findings from a recent study on CER-0001 (tricaprilin), an investigational ketogenic agent, indicating that certain individuals suffering from migraines may experience benefit. The data will be used to inform future studies. The study's findings were highlighted in a poster presentation at the 65th Annual Society Meeting of the American Headache Society, held in Austin, Texas from June 15-18, 2023. The poster was presented by Cerecin's Chief Medical Officer, Dr. Marc Cantillon. The poster was entitled, Metabolic Mechanism in Migraine: Tricaprilin, a Ketogenic Agent.

The RELIEF study was a double-blind, randomized, placebo-controlled, 3-month study of up to 60 g/day tricaprilin. The primary endpoint was the change from baseline in the number of migraine headache days (MHDs) during month three. Eligible participants had 4-24 MHDs in the baseline period. The study was registered on clinicaltrials.gov (NCT04437199). The primary endpoint was not met due to lack of statistical power, however, an efficacy signal was noted in sensitivity analyses. Some patients opted to enter the CER-0001 Compassionate Access Program which provides continued access to CER-0001 (tricaprilin) for up to one year after completion of the clinical study.

Given that metabolic factors have been implicated in migraine etiology, the induction of ketosis via ketogenic drugs like tricaprilin could potentially offer an innovative approach to managing this condition. Professor Mark Bloch, Associate Professor at University of New South Wales, Sydney and RELIEF study investigator commented, "It is important that the headache field is aware of development of novel mechanism drugs, such as tricaprilin. This metabolism-based option is promising and should continue in development as a possible future treatment option."

The RELIEF study's preliminary findings support the further study of the investigational drug tricaprilin as a preventive treatment for migraines and affirm Cerecin's commitment to exploring cutting-edge therapeutics in the field of neurology.

About Migraine:

Migraine is the most prevalent neurological condition in the world and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Globally, hundreds of millions of people suffer from migraine. Migraine is characterized by debilitating headaches that last four to 72 hours and can be associated with nausea, vomiting, sensitivity to sound (phonophobia) and light (photophobia).

About Cerecin:

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin is supported by two multinational partners, Nestlé S.A. (NSRGY) and Wilmar International Limited (SGX: F34), as well as a syndicate of leading institutional investors. By bringing together the deep expertise of its leadership team, Cerecin is becoming a global leader in bioenergetics and neurometabolism.

About CER-0001 (tricaprilin):

CER-0001 (tricaprilin) is an investigational drug being developed by Cerecin for various neurological indications, including Alzheimer's disease, migraine, and rare epilepsies. CER-0001 is a ketogenic compound and is intended to leverage the numerous activities and benefits of ketone bodies.

Forward looking statements:

This press release contains "forward-looking statements" under applicable securities laws that are based on the current expectations and beliefs of Cerecin. Such statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will" and other words and terms of similar meaning. All statements, except for statements of historical fact, are statements that could be deemed forward- looking statements, including but not limited to: (i) sources and availability of third party financing and investments and the projected financial performance of the Company; (ii) the expected development of the Company's business, projects, drug development programs and joint ventures; (iii) execution of the Company's vision and growth strategy, including with respect to future growth; and (iv) new developments with respect to the Company's projects that are currently underway, in development or otherwise under consideration. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Forward-looking statements are not guaranties of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from projections of future performance or any result that may be expressed or implied by such forward-looking statements. Although forward-looking statements contained in this press release are based upon what management of Cerecin believes are reasonable assumptions, there can be no assurance or guarantee that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Cerecin undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

For more information visit www.cerecin.com.

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SOURCE Cerecin