Stayble Therapeutics announces final patient´s last visit in the Phase 2b clinical studySeptember 2023
Stayble Therapeutics AB (“Stayble” or the “Company”) today announces that the Last Patient Last Visit (LPLV) in the Phase 2b clinical study in degenerative disc disease has been completed. This means that the target number of evaluable patients in the study has now been reached twelve months after receiving treatment with STA363. The Phase 2b study, aimed at evaluating the pain relief of the drug candidate STA363, has been successfully concluded with high quality, good compliance and a low patient dropout rate. The company is following the previously communicated timeline and expects to communicate top line results in the fourth quarter of 2023.
Andreas Gerward, CEO of Stayble, comments:
"Our journey began in 2020 and much of the study has been conducted during the pandemic, which has required extra hard work from everyone involved. We are proud to have overcome all challenges, established the product´s safety, and seen positive preliminary interim data. We are approaching the most exciting part – to see what the results will reveal in terms of effectiveness. But before that, the collected data needs to be verified and quality controls need to be carried out before finally reported, after which the database is locked. Only then can data analysis begin to produce and compile the results. We estimate that all this will take two to three months. During this period, we will intensify discussions with potential partners."
Stayble is in the process of developing an injection-based single-use treatment for patients suffering from degenerative disc disease and chronic herniated discs. The current study is a Phase 2b clinical study entitled "A Multi-country, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of STA363 at Two Concentrations (60 mg/mL and 120 mg/mL) Compared to Placebo in Patients With Chronic Discogenic Low Back Pain". Patients completed four follow-up visits (after one, three, six and twelve months) to better understand the short- and long-term effects of STA363. The primary endpoint of the study is to demonstrate a statistically significant and clinically relevant reduction in pain at the six-month follow-up. Pain is measured with a numerical rating scale (NRS) ranging from 0 to 10, corresponding to no pain at all to extreme pain. In addition to pain relief, improvements in patient function, changes in MRI images, safety and tolerability will also be assessed.
The last patient has now completed all visits and rating scales. The study has maintained high quality and compliance. A total of 110 patients were included, of which 106 completed their six-month visit, which is the primary endpoint of the study, and a total of 101 completed their twelve-month visit.
For more information
Andreas Gerward, CEO Stayble Therapeutics AB
Phone: +46 730 808 397
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 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.