Sweden-based pharma and a leading European CRO obtain CTA approval for Russia.
The study with STA363 aims to prove efficacy and safety of the treatment in patients suffering from chronic discogenic low back pain. OCT Clinical will be overseeing the study with its enrollment target of 126 adult patients at about 20 clinical sites in the Netherlands, Spain and Russia.
Earlier this month Stayble announced that they had obtained approval from the Spanish regulatory authorities and ethical committees, and were also approved by a Dutch regulator back in March.
Stayble CEO Andreas Gerward comments: "The approval of our clinical trial application by the Russian authorities is an important step towards the start of our clinical phase 2b trial and a great achievement by our team and our collaborative partners. We are happy with the results OCT Clinical has been demonstrating as the principal CRO for the project. The next step after approval is site initiation, identification and recruitment of patients, and treatment of the first patients. Clinical phase 2b trial is estimated to start, if all goes according to plan, during Q2 of 2020."
Within this project, the OCT Clinical team is responsible for a wide scope of clinical trial services: project management, site management, data management, biostatistics, medical writing, medical monitoring, clinical monitoring, logistics, pharmacovigilance, quality assurance, and regulatory support.
“We are happy to help Stayble Therapeutics to obtain a full set of approvals and are excited about moving the study forward to further success,” said Irina Petrova, Director of Clinical Operations, at OCT Clinical. “We certainly love the challenge of running the project in three very different countries and look forward to reaching new milestones.”