Umecrine Mood has announced data from an exploratory Phase II study with its candidate drug UC1010 in patients with PMDD. The primary end point was not met in the study but post-hoc analysis indicates positive treatment effects in a subgroup of patients with the most severe problems. UC1010 was well tolerated and there were no safety concerns. Karolinska Development owns 38% of Umecrine Mood.
Most women experience some form of premenstrual symptoms but in about 5% of young and middle-aged women that have PMDD, the symptoms are so severe that they affect daily life in a debilitating way and relationships with other people. The severity of the symptoms confers huge costs on society.
In an exploratory double blind, randomised multicentre study, 120 patients with PMDD received, during one menstrual cycle, either placebo or one of two different doses of the drug candidate UC1010, a GABA-A modulating steroid antagonist (GAMSA). The objectives of the trial were to study the safety and effect of UC1010. The primary end point in the study was to assess symptoms using a validated daily rating scale (DRSP) containing the sum of the four cardinal symptoms for diagnosis of PMDD measured as the average score during the late luteal phase (the premenstrual week) in the active dose arms combined versus placebo.
The outcome of the study shows a reduction in the average late luteal phase score after treatment versus before treatment of 61% in the active group and 55% in the placebo group. The difference between the active group and placebo was not statistically significant and the primary end-point of the study was thus not met. In a post-hoc analysis there was a statistically significant difference (p<0.05) between active treatment and placebo in patients with severe problems during a week or more per cycle. Moreover, differences were observed in the PMDD symptoms that are clinically most relevant. There were no safety concerns with UC1010 and it was well tolerated.
“PMDD symptoms occur following ovulation and are suggested to be related to the action of progesterone metabolites on the brain's emotional centre to which PMDD patients are especially sensitive. Umecrine Mood is the first company to develop compounds with an entirely new mechanism of action that inhibit the activity of these metabolites. The study has demonstrated a good safety profile and warrants further analyses”, says Karin Ekberg, CEO of Umecrine Mood.
