Stayble Therapeutics reports top-line data from the company's phase IIb study
Stayble Therapeutics AB ("Stayble" or the "Company") today presents top-line data from the Company's phase IIb study with STA363 for the treatment of degenerative disc disease, "DDD". The randomized, double-blind study did not meet the primary objective. According to the pre-specified statistical criteria, STA363 compared to placebo did not show a statistically significant reduction in pain at six months.
The study was a randomized, double-blind, placebo-controlled concept study investigating the efficacy and safety of two concentrations of STA363 (60 and 120 mg/ml) compared to placebo in patients with degenerative disc disease. A total of 110 patients were enrolled.
According to the predetermined statistical criteria, treatment with STA363 did not show a better effect on pain reduction than treatment with placebo. However, all three groups showed a considerable reduction in pain after treatment. The company deems that a larger study would not have helped to detect a difference between the groups. Thus, the study is considered to be conclusive.
STA363 showed a good safety profile for up to 12 months. The study's secondary efficacy endpoints regarding function and quality of life did not show any significant differences between the two dose groups and the placebo group. In the high-dose group, however, the water content of the disk was reduced compared to the placebo group, which indicates increased transformation to connective tissue.
Stayble will continue to evaluate top-line data from the study with the aim of better understanding the results.
For more information
Andreas Gerward, CEO, Stayble Therapeutics AB
E-mail: andreas.gerward@stayble.se
Tel.: +46 730 808 397
This information is the type of information that Stayble Therapeutics AB is obliged to publish pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on November 9, 2023.
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 not helped by physiotherapy and painkillers, the treatment is a single injection expected to last a lifetime and requires minimal rehabilitation. The company is now focused on clinical development and is conducting a Phase 2b clinical trial in DDD and a Phase 1b trial in LDH.
Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.