Karin Ekberg Umecrine Mood
Karin Ekberg CEO Umecrine Mood AB

Positive results from Umecrine Moods exploratory Phase I/II study with UC1010 in premenstrual dysphoric disorder (PMDD)

Positive results from Umecrine Moods exploratory Phase I/II study with UC1010 in premenstrual dysphoric disorder (PMDD)

Umecrine  Mood’s candidate  drug  UC1010  is  a  first‐in‐class  therapy  for PMDD. UC1010 has been  developed  specifically  to  target  the  atypical  effects  of progesterone metabolites on GABA-A  receptor activity  in  the  brain,  believed  to underlie key PMDD symptoms. 
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,  we  report  here  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: 

1. 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).   

 

2. More significantly, 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.   

 

There were no safety concerns with UC1010 and it was well tolerated.   
     
  
Marie Bixo, Principle Investigator, 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 side­effects seen with other agents used for PMDD treatment”. 
Karin Ekberg, CEO of Umecrine Mood, commented: “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”. 
 
For further information, please  contact: 
Karin Ekberg, CEO,
Umecrine Mood AB 
Phone:  +46 8 524 844 82, e‐mail:
karin.ekberg@umecrine.se