Study demonstrated strong safety proliferation and reduced tics among participants
Asarina has completed patient recruitment into a Phase 2a clinical trial in Tourette’s syndrome, with a total of 28 patients enrolled.
The study’s dropout rate was unexpectedly low and top-line results are expected by the end of Q1 2023. The research compound, cepranolon, is an endogenous neurosteroid and an entirely new treatment for Tourette. It has shown strong safety growth in multiple previous clinical studies and reduced tics without inducing the side effects of exercise from previous preclinical studies.
Bispebjerg University Hospital, Copenhagen will start enrolling adult patients in February 2022, and from summer 2022, the Danish National Tourette Center at Herlev University Hospital will enroll teenage patients.
To date, a total of 13 patients have completed the study. The last-patient-last-visit remains he is scheduled for January 2023, and topline results are scheduled for the end of March 2023.
The dropout rate in this study was unexpectedly low, with only two patients dropping out of the study. In most clinical studies, the highest dropout rates tend to be in the “working dose” group rather than the control group.
If successful in full clinical development and regulatory approval, sepranolone will be the first endogenous neuroendocrine compound to be used to treat Tourette’s syndrome and represent an entirely new treatment without serious side effects.
Sepranolone is highly selective and designed to target and modulate the effects of allopregnanolone.Allopregnanolone – Potent neurosteroid in exacerbating tics – Off-target central nervous system side effects there is no.
Peter Nordkild, CEO of Asarina, said: We would like to thank the two teams for their tremendous expertise in ensuring a smooth study with highly motivated patients. We look forward to sharing our top line results. ”
Tourette’s disease mostly occurs in children between the ages of 4 and 12, and in some patients it persists into adulthood. Current treatments like Haldol (haloperidol) can have very serious side effects, and 44% of parents feel that current Tourette treatments do not adequately control their child’s symptoms Meanwhile, 29% of children have tried five or more different drugs.
