(Stockholm, 16 September, 2021.) An administrative backlog due to Covid-19 at The Capital Region of Denmark (Region Hovedstaden) is causing a delay of approx. 3 months to the initiation of Asarina Pharma's phase IIa study in Tourette Syndrome. The study is now expected to start in December 2021 and be completed at the end of 2022.
Asarina Pharma's Clinical Trial Application for its phase IIa study in Tourette Syndrome was approved by the Danish Medical Agency in May 2021 and has now received approval from the Ethics Committee. The only outstanding matter is the contract with the two clinical sites, Herlev and Bispebjerg Hospitals. Due to a backlog in the legal department of Region Hovedstaden (the administrative authority for the two hospitals), the site contracts cannot be processed for approx. 2 months
The Tourette study, scheduled to begin in September 2021 will consequently be delayed until December when we expect the site contracts to be signed. The study will be finalized at the end of 2022, not Q3 2022 as previously communicated.
CEO Peter Nordkild: "After executing our Phase II Menstrual Migraine study at the height of the pandemic and delivering results on schedule, this delay is frustrating. However, whilst inconvenient, it does not jeopardize the study. We retain sufficient funds for the study and remain firmly focused on our end goal - providing a safe, effective treatment that will help Tourette patients and their families remain in control of their life."