Stayble provides update on the ongoing Phase 2b study due to the covid-19 pandemic

21 Apr 2021 Regulatory

Stayble Therapeutics announced today that recruiting patients for the company's ongoing Phase 2b study with the drug candidate STA363 is slower than expected due to the covid-19 pandemic and the strict pandemic rules with several lock-downs in all study countries. Under current conditions, the company is expected to be able to report study results during the second half of 2022, which is later than previously communicated.

“We have been pleased to note that patients continue to be recruited in our study and there is great enthusiasm among the investigators at the participating clinics. At the same time, we see it as extremely important to safeguard the safety of patients and healthcare personnel and to prioritize the care of covid patients. We, together with participating clinics, are optimistic that the recruitment rate will increase as soon as the current pandemic wave is decreased, and communities begin to reopen. In the last months, we have seen increased activity at the clinics that can run the business free from restrictions, which is a good signal that we will be able to increase the pace when lockdowns are released in more places. The great need for effective treatment for chronic back pain that can offer patients lasting relief and increased function is completely unchanged.” says Andreas Gerward, CEO of Stayble.

The aim of the ongoing Phase 2b clinical trial is to confirm the safety and tolerability of STA363 and to demonstrate a reduction in pain and increased function in patients with chronic disc-related back pain. The study will include about 100 patients divided into three different groups, two of whom are treated with STA363 and one with placebo. Patients receive an injection and are then followed for a twelve-month period to better understand the long-term effects of STA363. The study has been initiated at about 20 clinics in all three study countries, the Netherlands, Russia and Spain.

The company change study timelines in the ongoing clinical Phase 2b study does not affect the company's capital requirements for conducting the study.

For more information

Andreas Gerward, CEO Stayble Therapeutics AB
andreas.gerward@stayble.se

+46 730 808 397

This information is such information that Stayble Therapeutics AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the above contact person, for publication on April 21, 2021 at 13:30 CEST.

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