Sweden-based Umecrine Mood has reported positive results from an exploratory randomised Phase I/II trial with its UC1010 drug candidate to treat patients with premenstrual dysphoric disorder (PMDD).
Compared to placebo, patients treated with UC1010 have showed significant improvement of symptoms.
Most women experience some form of premenstrual symptoms but in about 5% of young and middle-aged women who have PMDD, the symptoms are so debilitating.
The company has developed UC1010 to target the atypical effects of progesterone metabolites on GABA-A receptor activity in the brain, believed to underlie key PMDD symptoms.
A total of 120 patients with PMDD were given placebo or one of two doses of UC1010 during one menstrual cycle, in an exploratory double blind, randomised multicentre trial, whose objectives were to evaluate the safety and efficacy of the drug candidate.
The trial’s primary efficacy end-point was evaluated using a validated daily rating scale (DRSP), to measure the average late luteal phase symptoms in patients treated with UC1010 compared to those given placebo.
As previously reported, the primary efficacy end-point of the trial was not met, the company said.
Phase I/II trial principle investigator Marie Bixo said: "These results are very encouraging and well in line with effects seen in other studies (using antidepressants), with the added bonus that UC1010 is safe and well tolerated, with none of the side-effects seen with other agents used for PMDD treatment."
Umecrine Mood CEO Karin Ekberg said: "This exploratory Phase I/II trial is the first to show a beneficial effect of a novel mechanism-based therapy to treat a condition affecting a large proportion of women.
"We have learned some important lessons from this initial study and are now well-positioned to move forward to conduct a definitive Phase II clinical trial."
Karolinska Development owns 38% of Umecrine Mood including indirect ownership through KDev Investments, KCIF Co-Investment Fund and Umecrine.