Research has demonstrated a strong safety prolife and reduced tics among participants
Asarina has completed the recruitment of patients to its phase 2a clinical study in Tourette syndrome with a total of 28 patients enrolled.
The dropout rate in the study remains unexpectedly low, with top line results are expected at the end of Q1 2023. The study compound, Sepranolone, is an endogenous neurosteroid – an entirely new treatment modality for Tourette. It has demonstrated a strong safety prolife in multiple previous clinical studies and reduced tics without inducing any of the motor side effects from previous preclinical studies.
Enrollment of adult patients started at the Bispebjerg University Hospital in Copenhagen in February 2022, while teenage patients have been enrolled at the Danish National Center for Tourette at Herlev University Hospital since summer 2022.
Until now, a total of 13 patients have completed the study. Last-patient-last-visit remains scheduled for January 2023 with top line results expected at the end of March 2023.
The study has had an unexpectedly low dropout rate with only two patients having departed the research. In most clinical studies, the highest dropout rates tend to come from the ‘active dose’ group rather than from the control group.
If full clinical development and regulatory approval is successful, Sepranolone will be the first endogenous, neuroendocrinological compound used to treat Tourette syndrome – representing an entirely new treatment modality with no serious side effects.
Sepranolone is highly selective and has been designed to target and modulate the effects of allopregnanolone – a powerful neurosteroid in the exacerbation of tics – with no off-target central nervous system side effects.
Peter Nordkild, chief executive officer at Asarina: “Our work with the highly experienced teams at Bispebjerg and Herlev University Hospitals is progressing very positively. I’d 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 topline results.”
The majority of Tourette cases occur in children between four to 12 years old and for some patients it persists into adulthood. Current treatments like Haldol (haloperidol) can involve extremely severe side effects, while 44% of parents feel that current Tourette treatments fail to adequately control their child’s symptoms. Meanwhile, 29% of children have tried five or more different medications.
