Stayble Therapeutics enters the new year with focus on the phase Ib study in disc herniation. Patient recruitment is ongoing at four clinics and the company’s plan is to be able to present study results in 2024, without additional funding. CEO Andreas Gerward tells us more in an interview.
Stayble Therapeutics focuses on the development of the drug candidate STA363, for the treatment of disc-related chronic back pain. This is a one-time injection consisting of lactic acid that transforms the disc into connective tissue.
In 2023, the company completed a phase IIb study in patients with degenerative disc disease, and initiated a phase Ib study in patients with chronic disc herniation.
Focus on disc herniation after final data analysis
The company recently presented results from the phase IIb study in degenerative disc disease, confirming that the study did not achieve the primary objective. No statistically significant difference in pain was detected between placebo and active treatment with STA363.
Therefore, Stayble Therapeutics is now focusing entirely on the clinical phase Ib study with STA363 in patients with chronic disc herniation.
Chronic disc herniation
Herniated disc means that the disc gets a bulge, a hernia, which presses on the nerves creating a radiating pain in the leg, sciatica, back pain and reduced mobility. Today, patients are mainly treated with painkillers and physiotherapy, but sometimes surgery is required to remove the hernia.
Herniated discs, however, often resolve on their own, but in around 15 per cent of all patients, the pain becomes chronic. It is these patients that Stayble Therapeutics is targeting. According to the company, there are approximately 2.3 million chronic cases of herniated discs in the EU4, the UK, the US, and Japan.
The company’s vision is to offer a marginally invasive treatment that provides lasting pain relief and increased physical function – thereby increasing the patient’s quality of life.
STA363 reduces disc volume
Stayble Therapeutics strives to reduce pain by reducing the disc volume. This hypothesis is supported by the scientific literature and has formed the basis for previous treatment methods, according to an interview with Stayble Therapeutics’ CEO Andreas Gerward.
The treatment principle is also supported by the results from the phase IIb study in patients with degenerative disc disease. In the study, a statistically significant difference in disc intensity and disc height was observed in the patients treated with the high dose of STA363. This indicates that STA363 is affecting the disc, resulting in a decrease in disc volume.
Patient recruitment underway
Backed by these results, Stayble Therapeutics is now moving forward with the phase Ib study in patients with herniated discs. Patient recruitment is ongoing and a total of 24 patients will be recruited at four clinics in Poland. The study aims to determine safety and tolerability, as well as to show that the disc volume is reduced to demonstrate that the treatment concept works. The study will also evaluate the difference in pain intensity and the connective tissue transformation in the intervertebral disc.
After the injection of STA363, four follow-up sessions will be conducted; after one week, one, three and six months. The goal is to present results from the study in 2024, without raising any further capital. To make this possible, the company has cut down on personnel costs and overhead costs.
CEO Andreas Gerward tells us more
BioStock reached out to Stayble Therapeutics’ CEO Andreas Gerward to learn more about the company’s herniated disc project.
First of all, why is a new treatment option needed for patients with herniated discs?
– The simple answer is that there are currently no alternatives other than surgical procedures for patients who do not respond to conservative treatment with physiotherapy and painkillers. There is a great demand among treating physicians and patients for low-invasive, effective alternatives that provide long-term pain relief.
– There is a great demand among treating physicians and patients for low-invasive, effective alternatives that provide long-term pain relief.
Back pain is a very complex area of research and development. What motivates you to continue the development of STA363 in this area?
– Over the years, we have built up solid experience in the design, implementation and follow-up of studies in pain. Our phase IIb study did not give the result we had hoped for, but the study showed that STA363 provides the change in the disc we are looking for in disc herniation treatment.
– Herniated disc is a completely different indication based on another treatment principle than degenerative disc disease, namely a decrease in the volume of the disc. We have shown that STA363 achieves a relevant reduction in volume, which corresponds to levels that have provided clear pain relief in other scientific studies.
– With our experience, strong scientific support and a clear demand for a product like STA363, we look forward to continuing to drive development forward in an area with a huge unmet medical need.
Finally, what does the plan look like in the herniated disc project?
– We are on track with the development plan and will complete patient recruitment in Q1 2024. Thereafter, patients will be followed for a total of 6 months, with follow-ups at 1 week, 1 month and 3 months.
– The primary focus of the study is safety and tolerability, and we will communicate results during H1.
– Final data from the study will, as previously communicated, be presented in H2. We will return with more detailed timelines when the last patient has been treated in the 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.