Two clinical trials with Acetium® capsule for prevention of migraine-type headache have been concluded
Biohit Oyj Stock Exchange Release August 9th 2019 at 15.30 pm local time (EET)
In 2014, Biohit Oyj initiated two clinical trials for prevention of migraine-type headache attacks, testing the efficacy of Acetium® capsule. Because of a slow patient enrollment, the trial was subsequently extended to two additional clinical centers abroad. Despite this extension, the originally planned cohort size was not completely reached. In the whole series, Acetium® failed to show an efficacy statistically superior to placebo. Although the study results were not positive for the whole cohort, subgroup analyses disclosed migraine patients who benefit from Acetium®-capsule.
The purpose of the trial was to assess the effect of Acetium® capsule in prevention of headache attacks among patients suffering from migraine or cluster (Horton) headache. The study hypothesis was based on the concept that Acetium® capsules effectively block the acetaldehyde-induced liberation of histamine from the tissue mast cells which are ubiquitous in all human tissues. Histamine is a known trigger of migraine headache attacks while inducing a dilatation of small blood vessels in the brain.
Both studies were conducted as placebo-controlled, double-blind clinical trials, where half of the subjects received the active compound and the other half were administered a placebo.
Docent Mikko Kallela, MD, PhD (Helsinki Headache Center):
Even though the study results were not positive, the data disclosed a subgroup of patients who benefited from Acetium®. Monthly headache days in this subgroup were reduced by more than 50 %, and even more patients were found with a reduction of up to 25 % of their monthly migraine days. Migraine is a complex neurological disorder with diverse clinical symptoms and different treatment response to conventional therapy. It is essential to identify and further characterize this subgroup responding to Acetium®-capsule that has practically no side effects.
Professor Kari Syrjänen, MD, PhD (Chairman of the Scientific Advisory Board, Biohit Oyj):
In the whole series, Acetium® did not show a statistically superior efficacy compared to placebo. There is, however, some evidence that the Acetium® administration regimen might not have been optimal in this study. Instead of the used regimen (1 capsule twice a day), increasing the dosage to 2 capsules 3 times a day (after breakfast, lunch and dinner) should be considered in the future clinical trials. Increasing the dosage is considered safe because also this study confirmed an excellent acceptability of Acetium® capsules in all subgroups.
CEO Semi Korpela, Biohit Oyj
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Biohit in brief Biohit Oyj is a globally operating Finnish biotechnology company. Biohit’s mission is “Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B share (BIOBV) is quoted on NASDAQ OMX Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com