- Decrease in R&D costs after completion of PMDD study
- All budgets revised after PMDD results
- Cash position on 30 June 2020 sufficient to fund phase II studies in menstrual migraine and Tourette Syndrome
95% of patients have been recruited in our Phase IIa proof-of-concept study. In total since August 2019, we have enrolled 139 patients. Recruitment was slowed somewhat by Corona restrictions, but all seven of our test centers have now been recruiting at the pre-Covid rate since June 2020. We are confident in reporting topline results in Q2 2021.
We plan to initiate our Phase IIa proof-of-concept study in Tourette in the spring of 2021. In May we submitted an application to the FDA for orphan drug designation in children below the age of 18, hoping to receive approval in the fall of 2020. Our 4 months’ tox’ study is progressing on schedule and we aim to submit a Clinical Trial Application to the Danish Medical Agency during Q1 2021, initiating the study in Q2 2021.
In April 2020 we released negative topline results from our phase IIb study in PMDD. Sepranolone performed on a par with previous study results, however, a statistically significant difference from placebo could not be demonstrated due to an unusually high placebo response. Sepranolone demonstrated an excellent safety profile Results were extensively covered in our 2020 First Quarter Interim Report and on our website.