Asarina Pharma AB (publ) (ASAP: FN Stockholm) has reached full patient enrolment in its Phase IIa menstrual migraine (MM) study. 158 women have been recruited as scheduled at seven test centers across Sweden and Finland despite Covid-19 restrictions. Sepranolone, the endogenous compound being tested for MM, is the first therapy to focus exclusively on menstrual migraine. MM affects 50 million women worldwide and is resistant to standard migraine treatments including the new CGRP antibodies. Topline results are expected in Q2 2021.
In the Spring of 2020, four of Asarina Pharma’s seven test centers in its randomized, placebo-controlled Phase IIa menstrual migraine study had to halt recruitment for several weeks due to Covid-19. Despite the temporary disruption, full recruitment was not majorly delayed. 158 women in total have now been enrolled.
“Full enrolment in the middle of a pandemic reflects the strength of the unmet need” says Dr Märta Segerdahl, Asarina Pharma CMO and Study Director. “The WHO recognizes migraine as the leading cause of life lived with a disability for women of reproductive age - yet Sepranolone is the first therapy to focus specifically on menstrual migraine. It is a first-inclass compound, produced naturally in the body, and an entirely novel way of treating migraine.”
Menstrual migraine and Sepranolone
Unlike standard episodic migraine, menstrual migraine attacks are predictable and recurring. They take place in the three days prior to and during menstruation - when concentration of the powerful neurosteroid allopregnanolone (ALLO) is dropping rapidly. For women with MM, attacks could be triggered by this sudden drop in ALLO. Sepranolone is identical to isoallopregnanolone - the endogenous compound produced naturally in the body that regulates and inhibits the negative effects of ALLO. Asarina Pharma patented Sepranolone as a pharmaceutical formulation in 2010. Highly specific and targeted, Sepranolone has achieved an excellent safety profile in repeated studies. In phase IIa and IIb trials for PMDD it was administered to hundreds of women in thousands of doses with no severe adverse effects. Topline results from Asarina Pharma’s Phase IIa menstrual migraine study are expected in Q2 2021.