At the beginning of the week, the pharmaceutical company Stayble Therapeutics achieved an important milestone in the phase IIb study with STA363 when 100 patients had completed their 6-month visit. This means that Stayble has secured all the necessary data required to evaluate the study’s primary endpoint – to show pain reduction in patients with chronic disc-related back pain. Stayble is now one step closer to presenting top-line data, which is expected to take place during the fourth quarter of 2023.
Gothenburg-based Stayble Therapeutics is developing the injection treatment STA363 that focuses on the underlying causes of chronic disc-related back pain. The candidate consists of lactic acid that transforms the disc into connective tissue, which is expected to provide a permanent pain reduction for the patient.
Phase IIb study is nearing completion
The efficacy of the treatment is currently being evaluated in a clinical phase IIb study in patients with chronic disc-related back pain, also called degenerative disc disease. The study compares two concentrations of lactic acid, 60 mg/ml and 120 mg/ml, with placebo.
The primary objective of the study is to demonstrate a statistically significant and clinically relevant reduction in pain. The pain is measured with a Numerical Rating Scale between 0 (no pain) and 10 (extreme pain). In addition to pain, the study also evaluates the patient function, changes on MRI images, safety and tolerability.
100 patients have been followed up
Stayble has now reached an important sub-goal of 100 patients completing their 6-month follow-up in the study. Statistically, this is enough patients to be able to determine whether the treatment is working as intended. As a result, the risk associated with the extraction of the study data has been significantly reduced. Stayble’s CEO Andreas Gerward comments on the milestone in a press release:
»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«
The company also announces that 50 per cent of patients have completed their 12-month visit, which is the last follow-up. The study includes four follow-ups at 1, 3, 6 and 12 months, which enables evaluation of the short- and long-term effects of the treatment.
Can lead to breakthrough in back pain
Stayble will now focus on completing all 12-month follow-ups. Thereafter, the company will analyse and present data from the study, which is expected to be done in the fourth quarter of 2023. These will be the first results that can give a clear indication of the treatment’s effect on pain.
If the results show that STA363 provides a statistically significant reduction in pain, it would not only be a breakthrough for the company, but also an important step for the millions of people suffering from chronic disc-related back pain. STA363 targets patients who do not respond to analgesics or physiotherapy, and who do not want or cannot undergo spinal surgery.
The ambition is that a single injection of STA363 will be enough to provide an effect that lasts the patient’s entire life and require minimal rehabilitation. However, if the patient has several diseased discs, several injections will be required.
More milestones in 2023
The data readout from the phase IIb study with STA363 is not the only milestone that awaits in 2023. During the year, Stayble will also have a pre-IND meeting with the FDA to discuss existing data and the study design for phase III, as well as the approval process in the US market. Stayble also plans to meet with the Swedish Medical Products Agency to get scientific advice for the European market.
Read more about Stayble Therapeutics’ plans for 2023 in BioStock’s latest interview with the company’s CEO Andreas Gerward.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.