Stayble Therapeutics recently recruited the last patient to the company’s phase IIb study with the drug candidate STA363 for discogenic chronic low back pain. The fact that the study is now fully recruited is in line with the communicated timetable to present study results by the end of 2023. The company’s CEO Andreas Gerward and CSO Anders Lehmann comments on the important milestone.
Stayble Therapeutics developing the drug candidate STA363 into a new standard treatment for patients with discogenic chronic low back pain who do not respond to conservative treatment such as analgesics and physiotherapy. STA363 is injected directly into the painful disc, giving rise to a connective tissue transformation that is expected to provide a permanent reduction in pain and an increased function.
The efficacy of the treatment is currently being evaluated in a clinical phase IIb study at approximately 20 clinics inthe Netherlands, Spain and Russia. The company has already presented positive interim results from the study that show good safety and tolerability, and that there is a good possibility for a conclusive outcome.
Fully recruited study
Despite challenges with patient recruitment during the Covid-19 pandemic, Stayble managed to increase the recruitment rate through a number of strategically targeted initiatives, such as incentive programs and expanded referral networks.
This have yielded results as the company now can announce that a total of about 110 patients have been recruited in the study. This means that the study is fully recruited, as it is estimated that approximately 100 evaluable patients are needed to be able to present results with regard to the primary endpoint.
Study results in 2023
There will now be a follow-up period where all patients will be followed for 12 months. After that, the data will becompiled and analysed, which means that study results may be available during Q4 2023.
In the meantime, the company will focus on interactions with regulatory authorities, not least the FDA, as well as intensify dialogues with potential partners.
CEO looks forward to the readout
BioStock had a chat with Stayble Therapeutics’ CEO Andreas Gerward and CSO Anders Lehmann regarding the fact that patient recruitment has now been completed.
Andreas, how does it feel to be finished with the patient recruitment of the phase IIb study with STA363?
– Amazing! It has been a challenging journey, but through diligent and creative work we have found ways forward and it has paid off. I am very proud of my co-workers and our partners who contributed to the fully recruited study.
What does it mean for Stayble that the recruitment for the phase IIb study with STA363 has been completed and that next year’s data readout is getting closer?
– The fact that the last patient has been recruited is an incredibly important milestone that also reduces the operational risk in the company. After STA363 is injected, we follow the patients for 12 months, which means that the study is now entering a follow-up phase.
»The fact that the last patient has been recruited is an incredibly important milestone that also reduces the operational risk in the company. «
Anders, could you tell us about the remaining steps before the final results are available?
– During the follow-up phase, the patients who have not completed all the return visits to the clinic will do so. For example, a new MRI scan is performed 6 and 12 months after treatment. When the last patient has made the last return visit, a quality check of all data takes place and when it is completed, the database is locked for further changes. After that, statisticians compile and analysze all the results according to a predefined plan. “Topline” data can be obtained in Q4 2023.
What is the likelihood of positive phase II results, in your view?
– It would be unwise of me or anyone else to comment on probabilities in this context. There are two pieces of the puzzle that must fall into place for a clinical study to be considered positive – safety and efficacy. When it comes to safety, I am absolutely convinced that the results will be excellent. I believe and hope, of course, that we will see a clear difference between placebo and STA363 in terms of pain relief. One reason for this optimism is that in thephase Ib study, we saw a change in the discs injected with STA363 but not with placebo. In animal experiments, we have shown that this change is due to connective tissue transformation, so the link between treatment and biological effect is there.
»I believe and hope, of course, that we will see a clear difference between placebo and STA363 in terms of pain relief.«
Andreas, you have also started discussions with potential partners, how far have you advanced in these discussions?
– We see a great interest in STA363 and our treatment concept. With a fully recruited study, the timeline is clear and we will during the autumn and 2023 intensify partnering activities as well as prepare the company for the next step in development.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.