First patient enrolled in Stayble Therapeutics’ Phase 1b clinical study in herniated discsAugust 2023
Stayble Therapeutics AB (“Stayble” or the “Company”) announces today that the first patient has been enrolled in the Company’s Phase 1b clinical study with STA363 for treatment of herniated discs. STA363 for Herniated discs is the second indication for the drug candidate STA363, which is also undergoing a clinical study in degenerative disc disease. Stayble has successfully completed a Phase 1b study in degenerative disc disease and is currently in the final phase of an ongoing Phase 2b study.
The Phase 1b study for herniated discs is a randomized, double-blinded, placebo-controlled study designed to evaluate safety and tolerability. Additionally, it will measure the effect on disc volume, bone pain, and disc intensity as secondary endpoints. Today, Stayble announces that the Company has enrolled the first patient out of a total of 24 patients who will be randomly assigned and treated with either STA363 or placebo (2:1 distribution). After the injection of STA363/placebo, four follow-up sessions will be conducted, one week after the injection, followed by sessions at one, three, and six months. The overall results of the study are expected to be presented at the end of the first half of 2024. The study is being conducted at four clinics in Poland in collaboration with the contract research organization Cromsource.
Andreas Gerward, CEO of Stayble, comments:
“We are pleased to have treated our first patient, marking an important milestone in our herniated disc study. The collaboration with Cromsource is progressing well, and we can confidently say that the work so far is proceeding according to plan. Building on our experience and learnings from previous studies with STA363, we feel well-prepared for an even smoother process this time.”
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 Ib trial in LDH.
Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.