Stayble Therapeutics announces today, July 31, 2020, that the first patient has been treated in Stayble’s clinical phase 2b study. STA363 is targeting patients suffering from chronic low back pain caused by disc degeneration.
The primary goal of the phase 2b trial is to demonstrate safety, tolerability and a clinically relevant reduction in pain in patients. The study will include some 100 patients and will be conducted by OCT Clinical as the principal CRO at about 20 clinical sites in the Netherlands, Russia and Spain. Patients will be treated with either a high or low dose of STA363 or placebo. The longest patient follow-up is after 12 months. The study is double-blind, which means that neither the patient nor the treating physician knows whether the patient is receiving STA363 or placebo.
CEO Andreas Gerward comments: That the first patient has been treated is a noteworthy milestone that we have been working intensively to achieve. We are now looking forward to the first clinic being initiated in Spain as well as additional sites in the Netherlands and Russia and that more patients will be treated soon.
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.
About Stayble Therapeutics AB
Stayble is a clinical stage pharmaceutical company developing the injection treatment STA363 for disc-related low back pain. The treatment is aimed at patients whose back pain persists after physiotherapy and painkillers. The injection is given once and the effect is expected to remain throughout the entirety of the patient’s life and to require minimal rehabilitation. The Company’s focus is set upon the continued clinical development of the upcoming clinical phase 2b study. Stayble’s vision is to develop STA363 as a new standard treatment for patients suffering from chronic disc-related low back pain.