The company has announced positive results from an exploratory Phase I/II study with UC1010 in premenstrual dysphoric disorder (PMDD).
On September 19 Umecrine Mood announced the final results from an exploratory randomized Phase I/II study with its candidate drug UC1010 in patients with PMDD. The company states that the results show a statistically significant improvement of symptoms in patients treated with UC1010 compared to placebo.
In an exploratory double blind, randomized multicenter study, 120 patients with PMDD received placebo or one of two doses of UC1010 during one menstrual cycle. The objectives of the trial were to study the safety and efficacy of UC1010. The primary efficacy end-point was assessed using a validated daily rating scale (DRSP), to measure the average late luteal phase symptoms in patients treated with UC1010 vs. those given placebo. As previously reported, the primary efficacy end-point of the study was not met.
Following final analysis of the study data, Umecrine Mood reports that UC1010 elicits a highly statistically significant reduction of symptoms in PMDD patients that have taken the drug according to the intended treatment regimen. The post-hoc analysis revealed two key variables that impacted the study outcome. Despite patient randomization, the baseline follicular phase symptoms showed a skewed distribution between study groups. Recalculation of results to correct for individual follicular symptoms reveals a statistically significant improvement of symptoms by UC1010 compared to placebo in the total study population (p<0.05 for the total premenstrual symptom score). Due to inconsistencies in the assessment of ovulation, 32% of patients did not receive treatment as intended according to the protocol. Inclusion only of patients treated as intended shows there were highly significant beneficial effects of UC1010 (both doses)
compared to placebo, both for the cardinal PMDD symptoms (p=0.003) and total premenstrual symptom scores (p=0.006) as well as for the impairment score (p=0.01), which specifically measures the impact of symptoms on daily life in the week prior to menstruation.
“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,” Marie Bixo, Principle Investigator.
Source: Umecrine Mood