- Significant increase in R&D costs
- Financial gain due to currency change in SEK
- Solid cash position on 31 March (110.0 MSEK)
SIGNIFICANT EVENTS DURING THE FIRST QUARTER
In April 2020 we released inconclusive topline results from our phase IIb study in PMDD. Our active Sepranolone substance 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 achieved an excellent safety prolife during the study. We will no longer be developing Sepranolone for PMDD, as proving an effect against such a high placebo effect would require thousands of patients but we are continuing our fully-funded studies for menstrual migraine and Tourette syndrome.
80% of patients were recruited for our phase IIa menstrual migraine study by the end of Q1 2020. During the quarter we opened a new study site in Lund, southern Sweden. Due to the Covid-19 pan- demic, three sites in Finland and one site in Sweden temporarily postponed further recruitment during the quarter, but all centers except the Stockholm center began recruiting again by the middle of May 2020. The study is scheduled to be completed during Spring 2021.
Plans and funding remain in place for our phase IIa study in Tourette syndrome due to be initiated in Q2 2021. We had a positive, productive consultation with the Danish Medical Agency in the beginning of March to discuss the necessary tox study and proposed clinical protocol. We are also in the process of submitting an application for orphan drug designation with both FDA and EMA that we hope will be approved before the end of 2020.
Asarina Pharma was reasonably well-funded prior to our PMDD study outcome. We have now reorganized and revised all budgets to ensure that our clinical studies in both menstrual migraine and in Tourette can be completed without any additional funding being required. We were well underway to be phase III-ready in terms of production upscaling, development of a tailormade autoinjector for the Sepranolone product and so on. Over the coming months we will mothball these activities, stopping them for now, but in a state where they can be quickly resumed when our menstrual migraine study hopefully yields positive results.
READ THE FULL REPORT HERE.