Asarina Pharma CEO Peter Nordkild: “2020 and early 2021 have seen new research and additional data confirming and consolidating the efficacy and potential of our flagship compound Sepranolone. As we continue forward into an eventful 2021, we remain confident of the significant clinical relevance of Allopregnanolone, and the ability of our flagship compound Sepranolone to suppress Allopregnanolone’s negative, often devastating effects.”
- R&D expenses remained at 2019 level reflecting strict cost control
- Staff costs declined following headcount reduction
- Solid cash position at year-end
TOURETTE SYNDROME (TS)
- Additional positive preclinical data was released in February 2021
- A preliminary, clean report from the juvenile tox study was received in mid-February 2021 confirming that we are able to dose children and men with Sepranolone for TS.
- We expect to submit a CTA to the Danish regulatory authorities for our upcoming Phase IIa Tourette syndrome study in the second half of March.
- We aim to initiate the study in June 2021.
MENSTRUAL MIGRAINE (MM)
- Our Phase IIa Menstrual Migraine study reached full recruitment in October 2020 with 164 patients recruited.
- The last patient was randomized on January 14, 2021.
- The last patient last visit is scheduled for April 20 2021.
- We are on schedule to publish topline results in June 2021.
PREMENSTRUAL DYSPHORIC DISORDER (PMDD)
- Additional data from a post hoc analysis of our 2020 Phase IIb PMDD study was presented by our CSO on February 12 2021 at the International Steroid and Nervous System Conference.
- The findings would be valuable to any larger pharma partner wishing to pursue future PMDD studies, and confirm our confidence in Sepranolone as an effective modulator of Allopregnanolone.
- The Phase IIb study results and post hoc analysis in its entirety will be submitted for publication before the end of March 2021.