Stayble enrols the first patient in herniated disc study
Stayble has now enrolled and treated the first patient in the company’s clinical phase Ib study with STA363 for the treatment of herniated discs. This milestone marks a continued positive development for the drug candidate STA363, which is already undergoing a phase IIb study for degenerative disc disease. The company’s CEO Andreas Gerward shared his thoughts on the milestone in an interview.
STA363 is a lactic acid-based injection treatment that Stayble Therapeutics has developed for several years for the treatment of degenerative disc disease. Earlier this year, the company chose to broaden the use of STA363 to herniated discs, which CEO Andreas Gerward presented in a BioStock Investor Pitch in February 2023.
Since then, the company has been working to start a clinical phase I study with STA363 in patients with herniated discs. The study is conducted at four clinics in Poland and in collaboration with the contract research organisation Cromsource. According to Stayble, the collaboration is working well and the study process is progressing according to plan.
The first patient included
Stayble Therapeutics recently announced that the first patient has been included in the herniated disc study. The study will include 24 patients in total. These patients will be randomised and treated with either STA363 or placebo according to a 2:1 ratio.
After an injection of STA363 or placebo, patients will undergo four follow-up sessions – the first after one week, followed by follow-ups after one, three and six months. Conclusions and results from the study are expected to be available by the end of the first half of 2024.
Stayble takes steps towards effective disc herniation treatment
As with other phase I studies, the study is designed to assess the safety and tolerability of the drug candidate. The company will also evaluate the effect on disc volume, leg pain and disc intensity.
Chronic herniated discs often cause both back and leg pain as well as limited mobility. Stayble Therapeutics’ ambition is to offer patients a simple and effective treatment that addresses the underlying cause of the pain. The goal of STA363 is to eliminate the pain by reducing the size of the herniated disc.
CEO comments on the study design and milestone
BioStock contacted CEO Andreas Gerward to learn more about the phase I study with STA363 for the treatment of disc herniation.
Can you tell us more about the importance of recruiting the first patient to the clinical phase Ib study for herniated discs?
– The initial patient in a study is always special. This milestone not only represents the start of our clinical phase Ib study, but also symbolizes months of dedicated planning and preparation that led us here. Our clinics have now started administering the first injections, which motivates our investigators to find more patients.
»The initial patient in a study is always special. This milestone not only represents the start of our clinical phase Ib study, but also symbolizes months of dedicated planning and preparation that led us here«
The study aims to measure several endpoints, such as disc volume and leg pain. What results do you hope to achieve?
– The primary objective of the study is safety and tolerability, but we will also evaluate several secondary measures. One of these is disc volume, which serves as a clear biomarker for treatments for herniated discs. If we can observe volume change in patients, it strongly indicates that we can also expect to see pain relief in future larger studies.
– We will also measure leg pain in the study. It is important to remember that the study is not dimensioned (there are too few patients) to be able to demonstrate statistically significant differences, but we expect to be able to identify trends and individual changes from this study.
»We will also measure leg pain in the study. It is important to remember that the study is not dimensioned (there are too few patients) to be able to demonstrate statistically significant differences, but we expect to be able to identify trends and individual changes«
Can you explain more about the study design and why you chose this approach to evaluate the safety and tolerability of STA363?
– The study is designed to provide the basis we need to be able to take the next step in the development, which is a clinical phase II study. From the phase I study, we will be able to bring valuable data linked to disc volume, patient recruitment, time course and further established safety.
– The study is structured so that 2/3 of the participants receive STA363 and 1/3 receive placebo. This is done not only to include more patients in the active treatment group, but also to increase the attractiveness of participating patients as it is more likely to receive active substance.
– The study is conducted in Poland, a country with very good knowledge of clinical development. All clinics have experience from clinical studies, as well as disc injections and treatment of herniated discs.
»The study is conducted in Poland, a country with very good knowledge of clinical development. All clinics have experience from clinical studies, as well as disc injections and treatment of herniated discs«
Your drug candidate STA363 is now used for two different indications: degenerative disc disease and herniated disc. Can you name any advantages of having two projects?
– The biggest advantage is that we increase the potential of the company by being able to reach another large group of patients who currently have inadequate treatment options. Increased potential also increases the attractiveness of entering a partnership with Stayble.
– We have gained experience and learned from previous studies with STA363, which means that we feel familiar with the process, enabling an even smoother implementation this time.
The results from the phase Ib study are expected to be presented by the end of the first half of 2024. What milestones can stakeholders and investors expect in the meantime?
– Just like our phase IIb study, our phase Ib study is also double-blind. This means that neither we, investigators nor patients know who is receiving active or placebo. We estimate that the final results will be presented at the end of the first half of 2024. Until then, investors and other stakeholders can expect updates related to patient recruitment, study implementation and of course a fully recruited study.
»We estimate that the final results will be presented at the end of the first half of 2024. Until then, investors and other stakeholders can expect updates related to patient recruitment, study implementation and of course a fully recruited study«
– At the same time, we are approaching the results of our phase IIb study and continued intensive partnering work.
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.
