Stayble Therapeutics has recruited 75% of the patients in the ongoing phase IIb trial

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Stayble Therapeutics AB (“Stayble” or “the Company”) announces today that the Company has recruited 75% of all patients with chronic disc-related back pain to the ongoing clinical phase IIb study with STA363. The company has made several efforts to increase the recruitment of patients for the study at the participating clinics in Russia, the Netherlands and Spain. These activities, together with a reduced impact of the Covid-19 pandemic, have resulted in a significant increase in recruitment rates and activity at the clinics involved. The recruitment speed is in line with the set schedule and the goal of recruiting all patients during the year.

For the Company, patient recruitment has been an important priority for a long time and several measures have been put in place to increase recruitment. The measures include, among other things, expanded remittance networks, social media campaigns, individual incentive programs, dissemination of best practice, inspirational lectures by testers and Key Opinion Leaders and more. The efforts have resulted in a positive impact on recruitment and in 2022, a maximum level in the number of screened and recruited patients per week has been reached. Now Stayble can announce that 75% of the total population has been recruited.

 

CEO Andreas Gerward comments:

Our persistence and continuous efforts to increase and improve patient recruitment have paid off and we have seen a significant increase in recruitment in 2022. Pharmaceutical trials often have a much lower patient recruitment rate at the beginning of a trial than at the end when all clinics are up and running and know exactly how to identify the right patients. Our trial also follows this pattern. Looking ahead, screening and pre-screening rates of patients are higher than before and I feel very optimistic for continued high patient recruitment in the coming months.

 

The aim of the study is to evaluate the effect of STA363 injections in degenerated discs on pain and function in patients with chronic disc-related back pain, and to study the safety and tolerability of STA363 injections in these patients. The study will include approximately 100 evaluable patients divided into three different groups, two of whom are treated with STA363 in two different doses and one with placebo. Patients receive an injection into the painful disc (s) and are then monitored for a 12-month period to determine the long-term effects of STA363.

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.

Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser and can be reached at +46 (0) 11 32 30 732 or e-mail ca@skmg.se