PHASE II B STUDY
POST-HOC ANALYSIS
Professor Torbjörn Bäckström, Founder and Chief Science Officer, Asarina Pharma and Senior Professor in Obstetrics and Gynecology, University of Umeå
‘SIGNIFICANT TREATMENT EFFECT’ DEMONSTRATED IN POST-HOC ANALYSIS OF PHASE IIB PMDD STUDY
In November 2021 “A randomized, double-blind study on the efficacy and safety of sepranolone in premenstrual dysphoric disorder” was published in the Journal of Psychoneuroendocrinology. It included a post-hoc analysis of data from Asarina Pharma’s Phase IIb study (topline results released April 2020) that demonstrated that Sepranolone in a 10 mg dose did have a significant treatment effect compared with placebo, when examined in an extended 9-day analysis of symptom reduction.
Senior PMDD Key Opinion Leaders who co-authored the publication with Asarina Pharma CSO Prof Torbjörn Bäckström (Uneaå University, Sweden):
Prof.Nick Panay Imperial College London
Prof. Shaughn O’Brien Royal Stoke University Hospital, UK
Prof. C. Neill Epperson Dept. Psychiatry, University of Colorado
Prof. Marie Bixo Umeå University, Sweden
Dr. Angelica Lindén Hirschberg, Karolinska University Hospital, Stockholm, Sweden.
KEY FINDINGS OF POST-HOC ANALYSIS
Key findings:
- A significantly larger number of individuals experienced no or minimal symptoms (Sum21 < 42 points) with the 10 mg Sepranolone treatment compared to placebo.
- The Sepranolone 10 mg was significantly better than placebo (p = 0.008), and similar significant treatment effects were found for the impairment and distress scores.
- ”These results indicate that there is an attenuating effect by Sepranolone on symptoms, impairment, and distress in women with PMDD especially by the 10 mg dosage”
SEPRANOLONE AND PMDD CEO STATEMENT
The topline results released in April 2020 found that Sepranolone failed to meet its primary or secondary clinical endpoints in its 5-day targeted treatment period due to an unexpectedly high placebo effect. However, as can be seen, the post-hoc analysis that investigated the treatment effect during an extended 9 premenstrual days in the third treatment cycle, did demonstrate a treatment effect. What does it mean for Sepranolone and PMDD? Asarina Pharma CEO Peter Nordkild:
Asarina Pharma CEO Peter Nordkild:
“These findings would be valuable to any larger pharma partner wishing to pursue future PMDD studies. We have been very clear that we do not intend to continue clinical development of Sepranolone for PMDD by ourselves – a study needed to further corroborate these findings would realistically involve at least six months of therapy and likely several hundred patients – which is clearly beyond our current capabilities.
“Nevertheless, these data are exciting, and represent a promising body of evidence when it comes to a pharmaceutical treatment for PMDD.
“They further clearly point towards allopregnanolone’s role as a key factor in triggering highly disruptive, mood-altering symptoms, including our current focus areas of Tourette and OCD – and confirm our confidence in Sepranolone as an important and effective modulator of allopregnanolone.”
