Stayble reports last patient last visit in the phase IIb study
Stayble Therapeutics recently reached an important milestone in the development of a new treatment for patients suffering from chronic back pain. The last patient has completed all visits in the company’s phase IIb study in degenerative disc disease. Now the most exciting part awaits – to see if the results can confirm the treatment’s intended pain relief effect. BioStock contacted CEO Andreas Gerward to find out more about the milestone of having completed all patient follow-ups.
Stayble Therapeutics addresses the growing problem of degenerative disc disease and chronic disc herniation by developing the injection-based single-use treatment STA363. The company’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.
The company is currently conducting a phase IIb study with STA363 in patients with degenerative disc disease and a phase Ib study in patients with chronic disc herniation.
Phase IIb study evaluates pain relief
The phase IIb study is designed to assess the effects of STA363 on pain in patients with degenerative disc disease. According to the company, the study has been successfully conducted with low patient dropout rate, good compliance and high quality.
Patients have each received one dose of STA363 or placebo and then undergone follow-ups after one, three, six and twelve months. The primary endpoint is to demonstrate a statistically significant and clinically relevant reduction in pain at the 6-month follow-up. In addition to pain relief, Stayble also assess improvements in patients’ physical function, changes in MRI images, safety and tolerability.
Last patient’s last visit
The patient’s pain reduction is measured with a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (extreme pain). Now the last patient has completed all visits and rating scales. A total of 110 patients were enrolled, of which 106 completed their 6-month visit and 101 their 12-month visit.
This means that the company is on track with the previously communicated schedule, with the goal of communicating top line results in the fourth quarter of 2023.
Success despite challenges
A large part of the study was carried out during the pandemic, which has led to extra hard work by everyone involved, difficulties with patient recruitment and other challenges. However, the company has managed to get through all the difficulties, established the product’s safety and presented preliminary interim data which was positive.
Exciting period awaits
Now an exciting phase awaits when it is time to analyse the data and hopefully confirm the drug candidate’s effect. Before that, the company needs to verify and quality control the collected data, after which the database is locked. Only then can the data analysis begin to produce and compile the results. The company estimates that this could take two to three months.
In parallel, the company will intensify dialogues with potential partners for the next step in development – phase III and then possible commercialisation.
Interview with CEO Andreas Gerward
Stayble Therapeutics CEO Andreas Gerward tells us more about the study and the significance of the study results in an interview.
Congratulations on successfully completing all patient follow-ups. Could you tell us about the challenges you encountered during the pandemic and how you managed to carry out the study successfully?
– The biggest challenge during the pandemic was patient recruitment and that the patients wanted to stay at home instead of visiting the clinics. In addition, the pandemic affected the monitoring of clinics in a negative way because external persons were not allowed to visit the hospitals.
– We have always worked closely with our partners and involved clinics to support and facilitate their work even during the pandemic. We also worked intensively to identify other limiting factors in order to accelerate and streamline recruitment as soon as the impact of the pandemic subsided. This was something we did very well and we saw a clear increase in recruitment.
With 106 patients who completed the six-month visit and 101 who completed the twelve-month visit, can you discuss the significance of these completion rates with respect to study success and the reliability of the results?
– Our goal in the study was to have at least 100 evaluable patients at the six-month follow-up. In clinical studies in general, and especially in longer studies, it is common with drop-out rates of up to 20 per cent. The fact that we in our study have been able to maintain significantly lower levels shows that our strategy has resulted in commitment from involved doctors as well as motivated patients. In addition, the fact that we reached over 100 patients even at the twelve-month follow-up gives us good opportunities to draw conclusive data from the entire study.
The press release mentions that you expect to communicate top results in the fourth quarter of 2023. Could you shed light on what stakeholders can expect from these results and how they can influence the company’s future?
– The result from the phase IIb study is the starting point for the next step in Stayble’s development and is absolutely crucial to be able to develop the concept further into a new treatment. Positive results would put us in a very good negotiating position in partner dialogues.
»The result from the phase IIb study is the starting point for the next step in Stayble’s development and is absolutely crucial to be able to develop the concept further into a new treatment. Positive results would put us in a very good negotiating position in partner dialogues«
The primary objective of the study is to show a statistically significant and clinically relevant reduction in pain at the six-month follow-up. Can you discuss the importance for patients with degenerative disc disease if this goal is achieved?
– A positive study result would mean that patients who are currently without treatment options will be able to get help in the future. This would mean a paradigm shift in the treatment method and standard for this type of patient in the future.
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.
