Umecrine Mood AB has announced that dosing has been initiated in a randomized Phase I/II study of UC1010 for the treatment of patients with premenstrual dysphoric disorder (PMDD).
Umecrine Mood is part of the Karolinska Development portfolio.
Most women experience some form of symptoms the days before menstruation but in about five percent of young and middle-aged women, the symptoms are so severe that they are considered to be suffering from PMDD.
This means that the symptoms in a debilitating way affect daily life and relationships to other people.
"The symptoms occur due to that a breakdown product of a sex hormone affect the brain's emotional center. Umecrine Mood is the first company to successfully develop compounds that are proven to reduce the activity of the breakdown product in healthy individuals. Now we take the next step to evaluate the safety and efficacy of our drug candidate in patients", says Karin Ekberg, CEO of Umecrine Mood.
The first patient has now been dosed with UC1010 in a double-blind, multicenter study in which the safety and efficacy of the product will be evaluated in a total of 120 individuals.
Principal Investigator is Professor Marie Bixo, Institute of Clinical Research and Education, Södersjukhuset, Karolinska Institutet.
"The currently available treatment of PMDD is primarily antidepressant drugs, which are not always effective and often cause side effects", says Torbjörn Bjerke, CEO of Karolinska Development AB.
Bjerke continued, "There is no doubt that these women are in need of an effective and targeted treatment, nor that the health economic benefits of being able to help the patient group would be significant."