Stayble Therapeutics gives update on phase IIb study
Yesterday, the pharmaceutical development company Stayble Therapeutics updated the market regarding the ongoing phase IIb study with its candidate STA363. Due to the strict measures introduced in the participating study countries to contain the Covid-19-pandemic, the pace of patient recruitment has been unusually slow, meaning that company will have to prolong the clinical trial in order to recruit a sufficient number of patients. BioStock has spoken to CEO Andreas Gerward about the implications of updated study timetable for the company.
Gothenburg-based Stayble Therapeutics is developing candidate ST363 for chronic disc-related back pain, a condition that leads to significantly reduced quality of life for patients and high costs for society. Treatment with STA363 is an injectable single dose, and it is aimed at patients whose symptoms do not improve after treatment with painkillers and physiotherapy.
Phase IIb study ongoing in three countries
The company is currently conducting a phase IIb study with the aim of demonstrating STA363’s safety, tolerability and effectiveness regarding increased function and lasting pain relief after treatment. The study will include circa 100 patients at 20 clinics in three countries. Last October, Stayble Therapeutics announced that it had initiated the first clinic in Spain, meaning that the study had been initiated in all three planned study countries, i.e., Spain, Russia, and the Netherlands.
Covid-19 affects patient recruitment
Yesterday, however, Stayble Therapeutics announced that the study is affected by the Covid-19-pandemic and its timeline is being extended. The three study countries have had strict national guidelines regarding the pandemic and have repeatedly entered lockdown. This has led to a slower rate of patient recruitment for the phase IIb study, and the company now estimates that it will be able to present study results in the second half of 2022 instead of the previously communicated first half of 2021.
BioStock had the chance to talk to CEO Andreas Gerward about what yesterday’s announcement means for the phase IIb study and the company.
Andreas, could you first give us a quick update on how the phase IIb study with STA363 is progressing?
– The study is currently underway in the three planned countries, the Netherlands, Spain, and Russia, and the first clinic started patient recruitment in the autumn of 2020. We have also worked intensively to involve more clinics in all study countries than initially planned in order to further increase recruitment capacity.
– In addition, we have built a larger network of clinics that refer patients to the treating clinics in order to increase the reach of the recruitment activities. We have a very good team that manages the study, as well as dedicated and competent clinicians who participate in the study. There is great enthusiasm regarding STA363’s potential for helping patients who today suffer from chronic low back pain without improvement.
»In addition, we have built a larger network of clinics that refer patients to the treating clinics in order to increase the reach of the recruitment activities.«
– The repeated lockdowns due to the pandemic in all three study countries have reduced the overall recruitment rate of patients. Clinics have had limited or even no capacity other than Covid-19 management. During the pandemic, the flow of non-emergency patients to the healthcare facilities has decreased. It is, of course, a good thing that people are responsible and do not seek unnecessary care in the highly burdened healthcare system. However, the typical patient for our study have had back pain for at least 6 months, i.e., not acute illness, which means that the patient recruitment rate has been slower than expected.
The pandemic has now been going on for more than a year. Your phase IIb study with STA363 started just a few months ago, so why are you now communicating that the study will be extended?
– Since the study is structured with a follow-up period of 12 months after the patient received a single dose of STA363 or placebo, we are looking at a time horizon of at least one year in the future. In study terms, this means that the last patient in the study must receive their treatment at least 12 months before we can report the first study results. We are quickly approaching this deadline and could see that the challenges of patient recruitment did not decrease as quickly as would have been necessary. After all, we have both a third/fourth wave of Covid-19 cases with restrictions that are once again being tightened in Europe and vaccinations seem to be taking longer than we hoped.
– These factors together contribute to the updated timetable and we work continuously with our partners to implement measures for increased recruitment. Our updated schedule places reporting of top line results during the second half of 2022.
»Our updated schedule places reporting of top line results during the second half of 2022.«
With a longer study period, it would not be surprising if the capital requirement for the company also changes, what does this look like for Stayble?
– No, we have no increased capital requirement in order to complete the ongoing phase IIb study.
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.