Stayble Therapeutics reaches important milestone – phase IIb-study fully recruited

August 2022 Regulatorisk

Stayble Therapeutics AB (“Stayble” or the “Company”) announces today that the last patient has been recruited in the ongoing phase IIb clinical trial of STA363 for chronic disc-related low back pain. Recruitment is thereby completed. The patients will be followed for 12 months after inclusion. Final results from the study are expected to be available in Q4 2023 after the Company has compiled and analyzed data from all treated patients in the study.

The primary objective of the study is to investigate the effect of STA363 on ongoing pain (primary endpoint) in patients suffering from chronic disc-related back pain, as well as mobility, safety and tolerability. The study is double-blinded, and patients have been randomized to one of two different doses of STA363 or placebo.  

 

Andreas Gerward, CEO, comments:

“We have now recruited the last patient in this important phase IIb study and have reached another significant milestone. The study has been ongoing during a challenging time to say the least, and I am therefore particularly proud of our recruitment efforts which reflect a strong effort by our team. I look forward with confidence to presenting the results of the study. In addition to ensuring that the study progresses and is completed in the best possible way, we will initiate interactions with regulatory authorities during the time leading up to the presentation of the results. Primarily, we will be applying for a pre-IND meeting with the FDA as well as intensifying our dialogues with ongoing and new potential partners.”

 

Previously, Stayble has presented positive interim results showing good safety and tolerability and indicating good prospects for an inclusive study outcome. A total of 110 patients have been recruited for the study. The follow-up is very good and to date, only one patient has left the study before the primary endpoint, which is positive. The study is being conducted at 14 clinics in the Netherlands, Spain and Russia.  

For more information

Andreas Gerward, CEO Stayble Therapeutics AB
andreas.gerward@stayble.se
+46 730 808 397

This is information that Stayble Therapeutics AB is obliged to make public according to the EU Market Abuse Regulation. The information was made publicly available by the Company’s contact person set out above on 31 August 2022 08.25 CEST.

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 and is currently conducting a clinical phase 2b. Stayble’s vision is to develop STA363 as a new standard treatment for patients suffering from chronic disc-related low back pain.

Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser and can be reached at +46 (0) 11 32 30 732 or e-mail ca@skmg.se