Stayble Therapeutics presents positive interim data from the ongoing phase Ib study with STA363
Stayble Therapeutics AB ("Stayble" or the "Company") announces today that the Company's phase Ib study has reached the follow-up goal of at least 18 patients completing their three-month visit. A total of 24 patients completed the visit. All essential data for evaluating the study's primary parameters have thus been secured. The company also presents positive interim data with established safety and tolerability (primary study objective) when evaluating available blinded data from the three-month follow-up. The patients will be followed until they complete their six-month visit. Then, the study is unblinded, and patients are divided into groups of those treated with STA363 or placebo. Today, approximately half of the patients have completed their six-month visit. The study is proceeding fully as planned, and the final results are expected to be presented in Q4 2024.
The company has analyzed blinded data from all patients who completed their three-month follow-up, which is the study's primary goal. The analysis shows continued established safety and tolerability; no sustained serious adverse events (SAEs) linked to STA363 or placebo have been reported. In addition to safety and tolerability, the evaluation shows a high quality of collected study data and good compliance with GCP (Good Clinical Practice) from the clinics involved.
In addition to safety and tolerability, the objective is to determine a reduction in disc volume to demonstrate that the treatment concept works in the intended way. With 24 patients who have completed their three-month visit, according to the statistical calculation, we have enough data points to be able to analyze objectives linked to safety and tolerability as well as volume changes. In addition to safety and volume, changes in pain will also be measured. The risk linked to gathering the study's data has thus been reduced, and an important interim goal has been passed. Going forward, Stayble will focus on remaining patients completing their six-month follow-up.
Andreas Gerward, CEO of Stayble, comments: "It is with pleasure that we have now reached this important milestone and taken a step closer to presenting the results of our phase Ib study. With a continued established safety profile, we see good opportunities for the study to achieve its primary goal. I look forward to presenting the study results and hope they confirm the potential of STA363 for treating pain caused by disc hernia.”
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 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 1b and 2b) 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.