(
A total of 28 patients took part in the study: a `control group' of 9 patients who received their standard treatment, plus an `active group' of 17 who received their standard treatment plus 10 mg injections of Sepranolone twice weekly for 12 weeks. Only two patients dropped out of the study - one from the active group and one from the control group. Patients ranged from 12 to 45 years old. Adult patients were treated at the
The active group was significantly larger than required in the Study protocol. The protocol is designed to detect a 25% difference in the Yale Global Tic Severity Scale (YGTSS), the study's clinical endpoint, based on an active group of 10 patients. The YGTSS is the standard clinical rating instrument used in Tourette and other tic disorder studies. It measures and evaluates the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.
Peter Nordkild, CEO: "With an unusually low dropout rate and a large active group we hope to be able to deliver clear and detailed findings of Sepranolone's potential impact on Tourette. We look forward to releasing the study findings at the end of
TREATING TOURETTE: A SIGNIFICANT UNMET NEED
The unmet need for a safe, effective pharmaceutical treatment of Tourette is well-established. A 2018 survey by the
The compound being trialled in the study, Sepranolone (isoallopregnanolone), has been found to reduce tics without inducing any off target motor side effects in several preclinical studies (2) and has demonstrated a strong safety profile in multiple clinical studies. Over 300 women have taken Sepranolone in previous trials with no other side effects than mild and reversible local skin irritation.
A NEW TREATMENT MODALITY FOR COMPULSION-RELATED CONDITIONS
Sepranolone is one of the first neuroendocrinological compounds to be tested for the treatment of Tourette. It is an endogenous neurosteroid produced by the body specifically to target and modulate the effects of Allopregnanolone - a powerful neurosteroid implicated in the exacerbation of tics, and a range of other stress- and compulsion-related indications. 86% of Tourette patients have at least one additional disorder co-morbid with Tourette, with OCD being particularly prevalent. In
(1) 2018, the
(2) -Preliminary study of finasteride in Tourette syndrome,
For further information, please contact:
Peter Nordkild, CEO
Phone: +45 25 47 16 46
E-mail: peter.nordkild@asarinapharma.com
ABOUT
We are a Swedish biotech company developing Sepranolone for allopregnanolone-induced stress- and compulsivity-driven disorders. Our product pipeline is built on over 40 years of research into allopregnanolone-related neurological disorders. With our new family of GAMSA compounds (GABA-A Modulating Steroid Antagonists) we aim to deliver a new generation of safe, efficacious drugs for neurological conditions from Tourette syndrome to Obsessive Compulsive Disorder that still lack safe, efficacious pharmaceutical treatments.
https://news.cision.com/asarina-pharma/r/last-patient-last-visit-for-landmark-tourette-syndrome-study,c3707816
https://mb.cision.com/Main/17069/3707816/1822534.pdf
(c) 2023 Cision. All rights reserved., source