Stayble Therapeutics secures all key data from ongoing Phase IIb study with STA363
Stayble Therapeutics AB ("Stayble" or the "Company") announces today that the Company's Phase IIb study has reached the follow-up goal of 100 patients completing their 6-month visit. As a result, all necessary data to evaluate the study's primary efficacy endpoint has been secured. All patients will continue to be followed until they complete their 12-month visit after which the code will be broken if the treatment is effective. To date, approximately 50 percent of patients have completed their 12-month visit. Top-line data is expected to be presented in Q4 2023.
Andreas Gerward, CEO of Stayble, comments:
"We are very pleased to have reached this important milestone and to be one step closer to presenting the results of our phase IIb study. Despite troubled times, I am proud that we have been able to run the study without any obstacles and maintain high quality and good compliance. This is mainly thanks to the dedicated medical staff who have made the study possible, as well as our dedicated team who continue to work tirelessly to make this a successful study. If the study objectives are met, it will be a major step forward for the millions of people who suffer from chronic back pain. I look forward to sharing the results of the study and hope they confirm the potential of STA363 in the treatment of chronic back pain."
The primary objective of our study is to demonstrate a statistically significant and clinically relevant reduction in pain. Pain is measured using a numerical rating scale (NRS) between 0 and 10, meaning no pain at all to extreme pain. In addition to pain, the study will also measure increased patient function, changes on MRI images, safety, and tolerability. The title of the study is "A prospective, double-blind, placebo-controlled concept study of the efficacy and safety of two concentrations of STA363 (60 and 120 mg/ml) compared to placebo in 100 evaluable patients with degenerative disc disease". Patients will complete four follow-up sessions, (at one, three, six and twelve months) to better understand the short and long-term effects of STA363. Stayble uses improved methods to reduce the placebo effect and variability compared to other similar studies, with the aim of obtaining more precise measurements.
With 100 patients completing their six-month visit, the statistical calculation indicates that we have enough patients to answer the question of whether the treatment is working as intended. The risk associated with the extraction of the study data has thus been significantly reduced and an important milestone has been passed. Going forward, Stayble will focus on having all patients complete their 12-month follow-up.
For more information
Andreas Gerward, CEO Stayble Therapeutics AB
Mail: andreas.gerward@stayble.se
Phone: +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.
Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.