Stayble has, together with APL, completed manufacturing of the investigational drug for the upcoming clinical phase 2b study.
The Company announces that the investigational drug (two doses of STA363 and placebo) now is manufactured and quality assured by our partner APL.
CEO Andreas Gerward comments: The completion of the investigational drug is another valuable piece in the jigsaw for initiating our upcoming phase 2b study. We are now awaiting the approval of our previously submitted applications in the Netherlands, Spain and Russia, while we monitor the development of the COVID-19 situation and its impact on the study’s start date.
The goal of the clinical phase 2b trial is to demonstrate safety, tolerability and a clinically relevant decrease of pain in the patients treated with STA363. The trial will include approximately 100 patients and will be conducted in some twenty clinics 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