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First patient included in menstrual migraine study

Asarina Pharma AB (publ) (ASAP: FN Stockholm) today announced the first patient has been included in its Phase IIa trial of Sepranolone in menstrual migraine (MM). The study will include 80-90 patients and is expected to be completed by the end of 2020.

“Standard prophylactic treatments have no efficacy in menstrual migraine. Sepranolone is the most highly targeted prophylactic treatment for menstrual migraine I’ve seen. The protocol for the study is extremely clear and the science highly promising. With 50 million women worldwide living with menstrual migraine the demand for this kind of trial and this mode of action is huge.” said Dr Markku Nissilä, national country coordinator of the study in Finland.

With the intensity and frequency of MM attacks concentrated directly prior to and during menstruation, when concentration of the neurosteroid allopregnanolone is dropping rapidly, attacks could well be in direct response to this, with Sepranolone – the body’s endogenous regulator of allopregnanolone – effectively treating this withdrawal, and by doing so also treating MM.

Dr Nissilä has managed over 100 trials in migraine throughout Finland, testing treatments from new triptans to the most recent new range of migraine treatments – CGRP antibodies. “My experience was that MM attacks were the only kind to keep persisting throughout CGRP medication. Neither triptans nor CGRP antibodies are fully effective against MM yet”.

The study will take place in Finland, Denmark and Sweden with 80-90 patients aged 18-45 years and is expected to be completed by the end of 2020.

About menstrual migraine
Menstrual migraine (MM) is a highly specific and disabling form of migraine. Approximately 50 million women worldwide suffer from MM, which is often resistant to standard migraine treatments. According to the American Migraine Foundation MM can be the most challenging kind to treat and frequently does not respond to the same medicines that work the rest of the month. MM attacks are often more severe and prolonged, but they are predictably recurrent, unlike regular episodic migraine. That means they more often go un-reported and undiagnosed. Menstrual migraine is triggered by the naturally produced neurosteroid allopregnanolone. Sepranolone inhibits allopregnanolone and might thus prevent the development of menstrual migraine.

About Sepranolone
Asarina Pharma’s lead compound Sepranolone is identical to the body’s natural, endogenous substance that inhibits allopregnanolone, the neurosteroid that triggers both menstrual migraine and Asarina Pharma’s lead indication premenstrual dysphoric disorder, PMDD. Sepranolone is the first compound to target the specific mechanism that triggers menstrual migraine and is a hormone metabolite produced naturally in the body. As such it has a very good safety profile.