Stayble has submitted applications to regulatory authorities in Spain for start of the Phase 2b clinical trial.
The company can announce that an additional important step for starting the phase 2b clinical trial during Q2 has been completed. The company has submitted applications to regulatory authorities in Spain and previously in Russia and the Netherlands, the three countries in which the Company's phase 2b study is planned to be conducted.
CEO Andreas Gerward comments: The fact that we have submitted the application to all the regulatory authorities is an important step towards starting the trial and an important milestone for the company. We now look forward to initiating the study during Q2 2020.
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 about 100 patients and will be conducted at about 20 clinical sites in the Netherlands, Russia and Spain.
For more information
Andreas Gerward, CEO Stayble Therapeutics AB
+46 730 808 397
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.
Mangold Fondkommission AB is the Company’s Certified Adviser and can be reached at +46 (0)8 503 015 50 or e-mail email@example.com