All patients included in Stayble Therapeutics' phase Ib study in disc hernia with STA363
Stayble Therapeutics AB ("Stayble" or the "Company") announces today that the last patient has been included in the ongoing phase Ib clinical study with STA363 towards disc hernia. No significant side effects have so far been reported and currently, none of the included patients has discontinued their participation in the study. Results from the study are expected to be available in Q4 2024.
The ongoing clinical trial, conducted in collaboration with the contract research company CromSource and at four clinics in Poland, is a double-blind, placebo-controlled trial aimed primarily at studying the safety and tolerability of STA363. In addition to this, we will, among other things, analyze changes in disc volume and the impact on the patient's pain. The goal of the study is to have at least 18 evaluable patients. Patient recruitment has gone according to plan, with the goal of recruiting 24 patients to account for potential dropouts. As the patient recruitment takes place in parallel at several clinics and all patients included in the study were also offered treatment, a total of 25 patients were injected in the clinical study.
The patients are followed for six months after inclusion. This means that the last patients will have their last visit at the end of August, early September. The collected data will then be verified and quality-controlled, after which the database will be locked. After that, analyses of the data can begin to produce and compile the results. We estimate that all this will take two to three months. The final results from the study are expected to be available in Q4 2024.
Andreas Gerward, CEO, comments:
"The fact that we have now included the last patient is a significant step forward in this important phase Ib study. The study has gone according to schedule without delay, which we are very proud of. Clinical development has its challenges, but we, together with our subcontractor and investigators, have carried out successful patient recruitment. I now look forward to the next study stage and to report the results in Q4 2024.”
For more information
Andreas Gerward, CEO of Stayble Therapeutics AB
Mail: andreas.gerward@stayble.se
Phone: +46 730 808 397
About Stayble Therapeutics AB
Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for degenerative disc disease (DDD) and chronic disc herniation (LDH). Stayble's vision is to offer patients a simple and effective treatment that targets the underlying cause of the patient's chronic pain and provides lasting pain relief and increased physical function. The treatment is aimed at patients who are not helped by physical therapy and painkillers and is a single injection that is expected to last a lifetime and requires minimal rehabilitation. After convincing data from previous pre-clinical and clinical studies (phase Ib and IIb) in degenerative disc disease, which show a volume reduction of the discs, the Company is currently conducting a phase 1b study for the treatment of herniated discs.
The company's Certified Adviser is Svensk Kapitalmarknadsgranskning AB.