Stayble Therapeutics presents positive interim data from ongoing Phase 2b study
Stayble Therapeutics AB (”Stayble” or the ”Company”) is currently conducting a phase 2b study with the drug candidate STA363. The Company now presents positive interim data with established safety and tolerability as well as lower dispersion in pain measurements when analyzing now available blinded data from the six-month follow-up in the study.
"The fact that we once again can present positive interim data and now from around 100 patients, which is the inclusion goal in the study, is a very important milestone in our development. The positive interim results demonstrate a well-planned study and that we and our dedicated investigators and collaborators have been successful in obtaining the most reliable data possible. Currently, approximately 70 percent of all patients have completed their twelve-month follow-up and we look forward to continuing to follow the remaining patients and to presenting top-line data in the fourth quarter of this year” comments Andreas Gerward, CEO at Stayble.
The Company has analyzed blinded data from approximately 100 patients who completed their six-month follow-up, which is the primary endpoint of the study. The analysis shows continued good safety and tolerability and no Serious Adverse Events (SAE) linked to the Company’s drug candidate STA363 (or placebo) have been reported. In addition to safety and tolerability, the analysis also shows a lower spread than expected in the measurement of pain, which is believed to be due to the initiatives the Company has implemented to improve, among other things, pain measurement. A lower spread in data indicates a high probability for a conclusive outcome of the study.
Furthermore, the Company continues to see a low dropout rate of patients, high quality of collected study data and compliance with GCP (Good Clinical Practice) from involved clinics.
For more information
Andreas Gerward, VD Stayble Therapeutics AB
Phone: +46 730 808 397
E-mail: andreas.gerward@stayble.se
www.staybletherapeutics.se
About Stayble Therapeutics AB
Stayble is a clinical-stage pharmaceutical company developing the STA363 injection treatment for degenerative disc disease (DDD) and chronic disc herniation (LDH). Stayble’s vision is to offer patients a simple and effective treatment that addresses the underlying cause of the patient’s chronic pain and provides lasting pain relief and increased physical function. Aimed at patients who are not helped by physiotherapy and painkillers, the treatment is a single injection with an effect that is expected to last a lifetime and requires minimal rehabilitation. The company is now focused on clinical development and is currently conducting a Phase 2b clinical trial in DDD and a Phase 1b trial in LDH.
Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.