Asarina Pharma AB (publ) Interim Report Q2 2020 released
Asarina Pharma CEO Peter Nordkild: “The second Quarter 2020 has given us continued proof of the urgent need for new, safe and effective treatments for the devastating conditions that our flagship compound, Sepranolone, targets. Despite disappointing results in our Phase IIb PMDD study at the beginning of the Quarter, which we covered extensively in our Q1 Interim Report, this second Quarter powerfully underlined the unmet need for new, safe, effective treatments for menstrual migraine and Tourette Syndrome.”
- 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.
For further information, please contact:
Peter Nordkild, CEO
Phone: +45 25 47 16 46
Jakob Dynnes Hansen, CFO
Phone: +45 5132 3698
Erik Penser Bank AB
Phone: +46 8-463 83 00
About Asarina Pharma
We are a Swedish biotech company developing Sepranolone for allopregnanolone-related stress, menstrual and neurological disorders. Our product pipeline is built on over 40 years of research into allopregnanolone-related neurological disorders. With our new family of GAMSA compounds (GABAA Modulating Steroid Antagonists) we aim to deliver a new generation of efficacious and safe drugs for still widely untreated neuroendocrinological conditions.
The information above was provided by the CEO of Asarina Pharma AB (publ), for publication on August 19, 08.00, 2020.