Stayble Therapeutics comments the ongoing study in Russia

Stayble Therapeutics AB comments on the Company's ongoing clinical phase IIb study, which is ongoing in Russia, among other places. The company follows the development closely and our current assessment is that the study can continue without risking patient safety, quality or implementation. This means that the Company continues to follow the previously communicated timelines.

Since 2020, Stayble has been conducting a phase IIb study with the aim of developing STA363 as a new standard treatment for patients suffering from degenerative disc disease. The study is designed as a multicenter study and includes about 20 clinics in the Netherlands, Spain and Russia.

Stayble has so far included a large number of patients in Russia in the study and the majority of these are still under follow-up. We as a pharmaceutical company have a responsibility to ensure that patients who are included have access to the care and follow-up to which they are entitled, which is also a prerequisite for the ethical approval on which the study is based. Discontinuing the study in Russia at present would affect the scientific value of the study with the consequence that we exposed patients to unnecessary risk. With regard to the patients and the scientific value of the study, Stayble therefore makes the assessment that it is not justified to discontinue the study.

Stayble's view is that the phase IIb study can continue without risking patient safety, quality or the implementation of the study, but our position must of course be evaluated on an ongoing basis.

For more information

Andreas Gerward, CEO Stayble Therapeutics AB
andreas.gerward@stayble.se
+46 730 808 397

About Stayble Therapeutics AB

Stayble is a clinical stage pharmaceutical company developing the injection treatment STA363 for disc-related low back pain. The treatment is aimed at patients whose back pain persists after physiotherapy and painkillers. The injection is given once and the effect is expected to remain throughout the entirety of the patient’s life and to require minimal rehabilitation. The Company’s focus is set upon the continued clinical development and is currently conducting a clinical phase 2b. Stayble’s vision is to develop STA363 as a new standard treatment for patients suffering from chronic disc-related low back pain.

Mangold Fondkommission AB is the Company’s Certified Adviser and can be reached at +46 (0)8 503 015 50 or e-mail ca@mangold.se