(Stockholm, Sweden, 22 December 2021.) The Capital Region of Denmark (Region Hovedstaden) has now given official approval to Asarina Pharma to begin its phase IIa study in Tourette, following a four-month delay due to an administrative backlog.
The phase IIa Tourette study will take place at the Danish National Center for Tourette at Herlev University Hospital, Scandinavia’s largest Tourette department, and Bispebjerg University hospital. 30 patients ranging from 12 to 45 years old will be included in the study.
There is an acute un-met need for a safe and effective pharmaceutical treatment of Tourette. Current treatments like haloperidol (Haldol) reduce tics but involve severe side effects. Asarina Pharma’s compound Sepranolone reduced tics as effectively as Haldol but without inducing any motor side effects in preclinical studies in 2019. Data from an additional animal model confirmed the initial findings in February 2021.
Peter Nordkild, CEO: “We and the two study teams have been fully prepared to start this study since August, so we are now delighted that Region Hovedstaden has finally given us the go-ahead. Let’s not forget - 59% of children and teenagers take medication for their Tourette yet only 44% of parents feel it adequately controls their child’s symptoms. Sepranolone is a new opportunity for a safer, more effective treatment. We look forward to hitting the ground running at both test sites early in the New Year.”