A SAFER APPROACH
SEPRANOLONE A SAFER APPROACH
Asarina Pharma’s Sepranolone is a new, safer approach to Tourette. Sepranolone is the endogenous compound produced naturally by the body to modulate the effects of Allopregnanolone (ALLO), a key driver in the exacerbation of tics in children and adults with Tourette.
ALLO is a potent neurosteroid produced in the brain during stress situations. 2017 preclinical research indicated that increased ALLO production during stress enhances tics(2). A further Asarina Pharma preclinical Tourette study in 2019 (3) went on to demonstrate that Sepranolone can reduce the negative effects of increased ALLO not only when it is produced peripherally (as with PMDD or MM) but when it is produced as a stress hormone in the brain of both genders during Tourette.
A NEW APPROACH
Asarina Pharma CEO Peter Nordkild: “There are no neurosteroid-based medications currently being used to treat TS. This is a new direction in treatment, a completely new approach. The logic of the Sepranolone treatment is completely different. As a highly targeted hormone metabolite Sepranolone offers the possibility of a treatment that could be efficacious – without any of the side effects commonly caused by anti-psychotics like Haldol. A positive result would be extremely promising for patients and it would indicate that Sepranolone potentially could play a part in treating a range of other ALLO-related stress disorders.”
A SAFER APPROACH
Asarina Pharma’s preclinical study in Tourette published in May 2019 demonstrated that Sepranolone reduced tics on par with Haldol, without inducing any motor side effects, in an animal model of Tourette. The high specificity of Sepranolone means it has few side effects, and proved to have a strong safety profile in the company’s Phase IIb Study in PMDD. The company now plans to start a Phase IIa clinical study into Tourette, with 20 patients aged 14-45 years beginning treatment in Q1 2021 at the national Danish Tourette center at Herlev University Hospital’s Department of Paediatrics in Copenhagen, one of Europe’s largest Tourette units, with almost one thousand children in treatment. 1. Allopregnanolone mediates the exacerbation of Tourette-like responses by acute stress in mouse models 2. Isoallopregnanolone reduces tic-like behaviours in the D1CT-7 mouse model of Tourette syndrome.
“Sepranolone could mean a safe, secure prevention of Tourette symptoms, with no complicating side effects.
Our ultimate aim is to help children and teenagers with Tourette receive efficacious treatment that will empower them to remain in control of their lives.”
CEO Peter Nordkild