Home Interviews Stayble Therapeutics’ CEO comments on positive interim results

Stayble Therapeutics’ CEO comments on positive interim results

Stayble Therapeutics

Stayble Therapeutics’ CEO comments on positive interim results

10 November, 2021

Stayble Therapeutics has presented interim results from the phase IIb study with STA363 demonstrating good safety and tolerability, thus giving the opportunity for a conclusive outcome. At the same time, the company has announced delays caused by the pandemic’s effects on patient recruitment. In Russia, where the majority of patients are to be recruited, infection rates and death rates are currently very high. Therefore, Stayble Therapeutics expects to present top line results during 2023. BioStock contacted the company’s CEO Andreas Gerward for a comment.  

Stayble Therapeutics develops STA363, an injectable drug that focuses on the underlying causes of discogenic chronic low back pain. The company wants to offer a treatment alternative to those patients whose symptoms do not improve with painkillers or physiotherapy, as well as those who cannot or do not want toundergo back surgery.

Clinical phase IIb study to demonstrate pain reduction

STA363 transforms the spinal disc into connective tissue, and thus has the potential to achieve a permanent reduction in pain in patients with discogenic chronic low back pain.

In 2020, the company initiated a clinical phase IIb study with STA363 to confirm the candidate’s safety and tolerability, as well as demonstrate a reduction in pain and increased function in patients. Those included in the study receive an injection of STA363 and are monitored for 12 months to evaluate the candidate’s long-term effects.

No serious adverse events have been reported 

The company has now presented interim data from the ongoing phase IIb study, which shows that STA363 is safe and tolerable, thus giving the opportunity to present conclusive data from the study. Stayble Therapeutics CEO Andreas Gerward commented on the results in a press release: 

»We are very satisfied with our positive interim results, which reflect a well-planned study and that we and our partners do everything in our power to get as reliable data as possible. Blinded data show that treatment with STA363 is safe and tolerable.«

No serious side effects have been reported and the study can be continued without restrictions. The interim results also show a low drop-out rate of patients and low variation between different clinics, which further underlines the candidate’s favourable safety profile.

Covid-19 pandemic slows down patient recruitment

Stayble Therapeutics’ phase IIb study is conducted at circa 20 clinics in the Netherlands, Russia, and Spain and will include approximately 100 patients. In Russia, the prevalence and death rates caused by Covid-19 are higher than ever right now, which has led to strict measures and extensive lockdowns being introduced in the country. So far, patient recruitment has progressed well in Russia, but the restrictions will make it more difficult.

Right now, patient recruitment is taking longer than planned; therefore, Stayble Therapeutics estimates that final study results from the phase IIb study can be presented in 2023. This corresponds to a delay of about six months compared to the previously communicated schedule. However, the new schedule does not give rise to an increased capital need according to the company.

Andreas Gerward, vd Stayble Therapeutics

Andreas Gerward is pleased with the interim results

In an interview with BioStock, Stayble Therapeutics’ CEO Andreas Gerward tells us more about the interim results and the company’s strategy for managing the Covid-19 pandemic’s effect on patient recruitment.

First of all, could you tell us about the interim results and the fact that you have now managed to show that STA363 is safe and tolerable?

– We have previously shown that STA363 is safe and tolerable in our phase Ib study, where 15 patients were  split into three different dosage groups and a placebo group. Interim data from phase IIb show continued established safety and tolerability. The fact that the favourable safety profile remains established reduces the development risk in the project. Data also show low variability, which gives the opportunity for a conclusive outcome of the study.

– The interim results are satisfactory in several other ways:

  • Low patient drop-out rates;
  • Committed investigators and clinics with high-quality results according to GCP (Good Clinical Practice); and
  • Low variability and little difference between the clinics’ results.

– The interim results show that our study is well planned and that we and our partners are doing the right things to get as reliable data as possible. The good results mean that the study can continue without restrictions – the only limitation is the negative impact on patient recruitment due to the Covid-19 pandemic.

»The interim results show that our study is well planned and that we and our partners are doing the right things to get as reliable data as possible.«

How do you work to reduce the placebo effect and variability in the study?

– We work actively with the education of patients and the involved physicians and staff. Furthermore, we register pain digitally for seven days at each follow-up period to get an accurate measure of the pain and reduce the risk of external factors or to capture an extra “good” or “bad” day, which does not reflect the patient’s pain over time. Analysis of this way of measuring pain shows reduced variability and increases the probability of conclusive data. Many previous studies that failed to show a difference from placebo have only measured pain on one occasion per follow-up.

What are your plans for dealing with the difficult Covid-19 situation in Russia?

– We continuously monitor information from the authorities in Russia and then make adaptions together with our local clinics and partners. Examples of the adjustments we make are resource allocation to the areas where Covid-19 has a lower spread. Furthermore, we are continuously investigating opportunities to accelerate safe patient recruitment.

How likely do you think it is that you will be able to keep the updated timelines, given the difficult-to-assess impact of the pandemic?

– When we decided on the new schedule, we took into account the historical recruitment rate and looked at opportunities in the future. We therefore see a good opportunity to keep to the updated timelines. I would also like to emphasise that thanks to a cost-effective study plan and efficient organisation, we do not have an increased need for capital despite a longer timeline until study results can be presented.

»We therefore see a good opportunity to keep to the updated timelines.«

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.

Prenumerera på BioStocks nyhetsbrev