Stayble Therapeutics has now initiated the first clinic in Spain for its clinical phase IIb study with the drug candidate STA363 for chronic disc-related low back pain. Thus, the study is underway in all prospective study countries – the Netherlands, Russia and Spain. BioStock has contacted Andreas Gerward, CEO of Stayble Therapeutics, to hear his thoughts on the announcement.

Stayble Therapeutics is developing an injectable drug, STA363, aimed at patients with chronic disc-related back pain. The company is currently conducting a phase IIb clinical trial with STA363 in order to demonstrate the candidate’s safety, tolerability and effectiveness in terms of reduced pain after treatment.

In an earlier interview with BioStock, Andreas Gerward, CEO of Stayble Therapeutics, said that he was pleased to have started the study in the Netherlands and Russia and that the company had so far managed to keep the communicated schedule – this despite the current situation with Covid-19. Now the first clinic has also been initiated in Spain, which means that the company has started up the study in all countries in which the study is to be conducted.

The study evaluates whether STA363 reduces back pain

 STA363 is intended for patients who suffer from disc-related chronic low back pain and who do not get better with analgesics and physiotherapy. During the treatment, a needle is positioned in the affected disk using an X-ray. Then STA363 is injected directly into the disc, which triggers the cells to produce connective tissue. This, in turn, stabilizes the segment and minimizes the possibility of leakage of inflammatory substances.

In order to determine whether the STA363 treatment leads to reduced pain and disability in the patients, the company is conducting a phase IIb study. Included patients will be treated with either a high or medium dose of STA363 or placebo. The study will cover approximately 100 patients across 20 clinics in the Netherlands, Russia and Spain.

The primary objective of the phase IIb study is to demonstrate a statistically significant and clinically relevant reduction in pain due to treatment with STA363 in patients with chronic disc-related low back pain. The pain is measured 6 and 12 months after treatment to examine the long-term effects of the treatment.

Challenges and the significance of the study

The effects of the Covid-19 pandemic, not least access to healthcare, have been a challenge for Stayble Therapeutics in the work of starting up the study clinics. However, the company has managed to stick to the overall schedule regarding patient recruitment in the phase IIb study, despite a later start than planned in Spain.

The company thus stands by the fact that data from the phase IIb study is expected to be presented during H1 2022. A positive study outcome would mean that Stayble Therapeutics has succeeded in achieving the company’s most important milestone to date – demonstrating  statistically relevant pain reduction with STA363. With such results, the company sees good opportunities to engage in collaborations with potential partners with strong resources who can take the project further through the ongoing clinical development and all the way to a market approval and launch.

BioStock has contacted Andreas Gerward, CEO of Stayble Therapeutics, to find out more about what the ongoing phase IIb study means for the company.

First of all, how does it feel that you have now succeeded in starting up the phase IIb study in Spain and thus started the study in all three planned study countries?

– I am very proud of my team and partners that we, despite challenges related to Covid-19, have received all regulatory and ethical approvals and then started up clinics in all countries. It is a very important milestone for both me and the company on the road to a new treatment for all the patients who today lack treatment alternatives for their back pain.

Can you describe what it is that has made Spain lag behind in comparison with the Netherlands and Russia?

– Spain, together with Italy, are the two countries in Europe that have been hit hardest by Covid-19. This has led to extensive restrictions and limited access to healthcare to conduct clinical trials. The restrictions eased during July and we were then able to resume discussions with the intended clinics. However, Spain has a holiday period in August and after an incredibly demanding spring in terms of healthcare, many doctors went on a well-deserved holiday. In summary, this means that Spain was not able to start until the beginning of October. We are now working intensively together with the clinics to be able to reduce the delay.

» We work with several clinics in each country and try to have a good spread of these geographically to reduce the impact of local outbreaks. «

Now that the spread of infection is increasing in several places, do you see any risk of further restrictions being introduced that may result in a reduced pace of recruitment of patients in the future? Is there anything today that indicates that you will have reason to review the schedule for the study in the future?

– This is something that we are monitoring closely, and we are working proactively to reduce the such risks. We work with several clinics in each country and try to have a good spread of these geographically to reduce the impact of local outbreaks. However, it is still more difficult and slower to implement clinical development with an ongoing pandemic. Despite this, we continue to follow the overall schedule. However, the company’s schedule may be negatively affected by further closure. We keep in contact with the clinics to be able to handle any difficulties in the best way.

Last week, Stayble Therapeutics’ VP Development, Professor Anders Lehmann, presented at Eurospine, which is one of the largest international scientific congresses in back research. What does such an appearance mean for the company?

– One of Stayble’s main ways to reach out to the scientific community is congresses such as Eurospine, so it is very important to actively attend these. It is also a hallmark of quality to be one of the 7 per cent that were selected for an oral presentation, which testifies to a great interest in our new technology. Anders presented the results from our phase Ib study in patients with chronic back pain and we hope to be able to build on this prominence in further interactions with this group.

Also read Stayble Therapeutics’ studies published in a leading journal to find out more about Stayble Therapeutics’ previous studies.

»I really believe that our treatment can succeed. We have a strong scientific rationale; we have shown biological effect in patients and we are working with an existing molecule that drastically reduces the risk of unexpected side effects.«

Finally, what would a positive study outcome mean for Stayble Therapeutics and how do you assess the probability that this will be the case?

– I really believe that our treatment can succeed. We have a strong scientific rationale; we have shown biological effect in patients and we are working with an existing molecule that drastically reduces the risk of unexpected side effects. At the same time, I try to be humble as I know that drug development is very risky and many projects fail along the way.

– The biggest challenge for those who suffer from chronic disc-related back pain today is that there is a lack of treatments for the cause of their pain, which means that it remains chronic. If Stayble could launch a product that changes that, and really manages to alleviate the pain in the long term, it would have a huge market impact. A positive phase IIb outcome would be a very important milestone to get us there. As STA363 consists of lactic acid ,which is a body-specific and well-characterized molecule, the risk of side effects in future phase III studies is low compared to many other projects, which drastically increases the probability that we can take STA363 all the way to a new drug.

– Stayble’s business model is to drive the development of STA363 on our own through the phase IIb study and then seek partners for further development and commercialisation. Our revenue model is therefore based on milestone payments and royalty income on future sales. A positive phase IIb result that underlines STA363’s treatment effect is what a resourceful and long-term partner is looking for in order to be able to take STA363 further towards market launch.

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.

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