The last patient visit was completed in Stayble Therapeutics’ herniated disc study
September 2024Stayble Therapeutics AB (“Stayble” or “the Company”) announced today that the last patient visit has been completed in the phase 1b study involving patients with pain caused by herniated discs. This company follows the previously communicated timeline and expects to present results during the fourth quarter of 2024.
A total of 25 patients were included, and 22 completed their 6-month follow-up, meaning the goal of having at least 18 evaluable patients in the study has been achieved.
CEO Andreas Gerward commented:
"I am very proud that we have conducted our clinical study according to plan and have exceeded our goal regarding the number of patients who completed all their visits in the study. We are now approaching the most exciting part – reviewing the study results. However, before that, the collected data needs to be verified and quality-checked, after which data analysis can produce and compile the results. We estimate this will take about three months. During this period, we will intensify dialogues with potential partners."
About the Phase 1b Study in Herniated Disc Patients
The study is a double-blind, placebo-controlled study primarily aimed at assessing the safety and tolerability of STA363. Additionally, changes in disc volume and the impact on patient pain are analyzed. In previous studies involving degenerative disc diseases, STA363 has shown a reduction in disc volume comparable to what has resulted in pain relief in previously published studies of patients with herniated discs.
The herniated disc project is based on the hypothesis that STA363 reduces the disc volume, which in turn decreases the size of the hernia and the pressure on nerve roots, thereby relieving pain. The correlation between treatments that reduce disc and hernia volume and their effect on nerve root pain caused by herniated discs is the treatment principle we aim for, and it has been validated in scientific literature. [1], [2], [3]
The clinical study is conducted in collaboration with the contract research company CromSource and at three clinics in Poland.
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.
[1] Splendiani et al. MR assessment of lumbar disk herniation treated with oxygen-ozone diskolysis: the role of DWI and related ADC versus
intervertebral disk volumetric analysis for detecting treatment response. 2013
[2] Bitz et al. An evaluation of narrowing following intradiskal injection of chymopapain. 1977
[3] Murphy et al. Percutaneous Treatment of Herniated Lumbar Discs with Ozone: Investigation of the Mechanisms of Action. 2016