Spine, the leading scientific journal for research on back pain, has published results from Stayble Therapeutic’s studies with STA363. The results show that STA363 induces connective tissue transformation in the spinal disc. This is the company’s goal in order to be able to treat patients who suffer from chronic disc-related back pain and who are not helped by physiotherapy and painkillers.
Stayble Therapeutics is developing an injection treatment, STA363, which focuses directly on the underlying causes of chronic disc-related back pain. The drug is injected into the disc that is hurting at only one treatment occasion, which causes a connective tissue transformation to occur. The company’s goal is to show that this can lead to a significant and permanent reduction in the patients’ pain.
The highly-ranked scientific journal Spine has published results from Stayble Therapeutics’ studies which have shown that the treatment is safe, tolerable and leads to the desired biological effect. Spine is a medical journal that covers research on back pain and the spine. The company’s CEO, Andreas Gerward, comments on the publication in the journal:
»Spine is the leading journal within our field. We could not have received a better seal of quality on our research. This will be an important part factor when we engage in upcoming discussions with Key Opinion Leaders and future partners« – Andreas Gerward, CEO Stayble Therapeutics
BioStock has previously interviewed Andreas Gerward regarding the treatment. Read the interview here.
The spinal disc degenerates with age
A spinal disc consists of two main parts – the nucleus pulposus (core) and the anulus fibrosus (the wall). The disc begins to degenerate at the age of 20, which causes cracks in the wall. This allows inflammatory molecules to leak out of the disk core and create pain in the patient. Furthermore, the core loses its gelatinous structure, which increases the risk of leakage. Disk degeneration also leads to instability in the segment. The instability and irritation of the nerves in and around the disc causes to pain that significantly affects the patient’s everyday life.
As you get older, the disc gradually transforms into connective tissue, which stabilises the disc and reduces pain. Stayble Therapeutics’ treatment replicates the natural process by converting the disc to connective tissue with the company’s drug STA363.
STA363 is based on lactic acid which is a endogenous and well-documented substance. This lowers the risk of detecting serious side effects in future studies. The goal is to transform the core of the disc into connective tissue with a single injection of STA363. The connective tissue transformation limits the production and leakage of inflammatory substances and stabilises the motion segment. Thus, STA363 has the potential to permanently achieve a significant reduction in the patient’s pain.
Preclinical studies yielded desired biological effects
The scientific article in Spine addresses the results from Stayble Therapeutic’s preclinical studies. The aim of the preclinical studies was to show that lactic acid leads to connective tissue transformation in the core of the disc. Three series of in vivo experiments were performed where each series had a slightly different focus. For example, series 2 was particularly dedicated to obtaining the regulatory documentation required by the Swedish Medical Products Agency in order to initiate studies in humans.
The experiments showed that a connective tissue transformation had occurred in all treated animals as had a reduction in the flexibility of the disc, which means that the motion segment had stabilised.
The phase Ib study showed that the treatment is safe
The article also includes results from the company’s phase Ib study in which 15 patients with disc-related chronic low back pain participated. The patients received an injection of lactic acid or placebo in the disc and were then followed for 12 months. Three different doses were tested – 30, 60 or 120 mg / mL.
The primary goal of the phase Ib study was to demonstrate the safety and tolerability of the treatment, which was successful. Some of the patients felt pain at the injection site during the injection or a transient back pain, but no lasting side effects or safety problems occurred.
It was also possible to observe the desired biological effect in the patients with the help of MRI. A connective tissue transformation had happened in the disc in patients treated with high or medium dose, but not in those receiving placebo or the lowest dose of STA363. Thus, the study had succeeded in repeating the results from the in vivo experiments that showed that STA363 induces a connective tissue transformation.
Does the treatment lead to reduced pain?
In order to be able to determine whether the STA363 treatment leads to reduced pain and disability in patients, a phase IIb study is now being conducted. Included patients are treated with either a high or medium dose of STA363 or placebo and they are then followed for a period of 12 months. In total, the study will cover about 100 patients and be carried out at 20 clinics in the Netherlands, Russia, and Spain. The study has been initiated in the Netherlands and Russia and the goal is to start in Spain in October.
Data from the phase IIb study are expected to be presented during H1 2022. In an earlier conversation with BioStock, the CEO of Stayble Therapeutics looked even further ahead and said that in 3 years – i.e. 2023 – the company will probably be advanced in discussions with potential partners and are ready for a market preparatory phase III study with STA363.
The publication in Spine is an important milestone
The fact that the company’s previous study results have been published in Spine is an important scientific validation since a publication is preceded by a review of renowned individuals in the field. This acknowledgment that Stayble Therapeutics is on the right track with its treatment may also be an asset in future discussions with potential partners. Stayble Therapeutics’ VP Development, Anders Lehmann, emphasises the importance of external validation:
»It is crucial to have external validation of our research and pharmaceutical development. The publication of clinical study results in one of the most highly ranked journals within our field, Spine, reflects the high level of interest in STA363 and marks a milestone for the company« – Anders Lehmann, VP Development Stayble Therapeutics
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.