Stayble Therapeutics | Research - Stayble Therapeutics

STA363 can do both

The STA363 treatment is a worldunique, patented innovation capable of alleviating the pain of patient’s suffering from both degenerative disc disease (DDD) and herniated discs (LDH).

Instead of costly and time-consuming procedures, such as spinal fusions or long-term physiotherapy, STA363 is administered as a one-time injection.

Removing the root cause of the pain

Both indications are single injection treatments tackling the root cause of the problem, and is expected to remain effective over a lifetime, requiring minimal rehabilitation. As such, it is anticipated to decrease the number of people on sick leave, reduce the usage of painkillers, and substantially increase the patients’ quality of life.

Making chronic back and leg pain treatment available – for everyone

Stayble´s treatment is intended for patients suffering from chronic back and leg pain thought to be caused by disc degeneration or disc herniation. Our main aim is to help people who do not respond adequately to conservative treatment. Our treatment is much less time-consuming than conservative therapies and an experienced radiologist or spine surgeon can perform it in less than an hour

Degenerative Disc Disease (DDD)

Stayble is on track to become the first minimally invasive disease modifying treatment addressing the underlying causes, instead of resorting to the temporary relief of analgesics and physiotherapy. Stayble has one R&D project, a one-time injection-based treatment for patients suffering from degenerative disc disease. The project is currently evaluated in a clinical phase 2b trial. The patient recruitment was finalized in August 2022 and 110 patients have been treated. Top-line data is expected in Q4 2023.

A typical patient suffering from DDD

30-50 years old
Greatly reduced quality of life
Doesn’t get better with 3-6 months of physiotherapy and analgesics.
Lack of treatment options

Intradiscal injection of a well documented molecule

STA363 is based on an endogenous and well documented small molecule together with a contrast agent assuring safe and accurate injection. Administration will be a single intradiscal injection. The effect of one single injection of STA363 is presumed to last the patient’s entire life and require minimal if any rehabilitation. STA363 transforms the disc into connective tissue and has therefore the potential to permanently achieve a significant reduction of the patient’s pain.

Healthy disc

A disc consists of two main parts: Nucleus pulposus (disc centre) and anulus fibrosus (disc wall). Nucleus pulposus consists largely of a highly hydrated gel together with nucleus pulposus cells and fibroblasts.

Degenerated disc

As the disc degenerates throughout ageing, tears in the anulus fibrosus appear and nucleus pulposus loses its gel-like structure resulting in a mechanically unstable disc. Inflammatory changes occur and the tears allow leakage of pro-inflammatory substances from the nucleus pulposus irritating and sensitising nerves both within and outside the disc.

Disc injected with STA363

One single injection of STA363 transforms the disc into dense connective tissue. The transformation restricts synthesis and leakage of pro-inflammatory agents and re-stabilises the intervertebral segment. By achieving these two effects, Stayble believes that STA363 has the potential to significantly reduce discogenic low back pain.

Lumbar disc herniation (LDH)

STA363 aims to significantly decrease nerve root pain caused by unresolved disc herniation and drastically increase the patient’s quality of life. Following the pre-clinical and clinical results from previous trials within degenerative disc disease, which indicate a volume-shrinkage of discs, the phase 1b trial of lumbar disc herniation treatment is planned to start during Q1 2023. The trial will focus on safety and tolerability, and to establish the shrinkage of the disc volume to demonstrate proof of principal of the treatment concept. Additional endpoints include pain and disc transformation into connective tissue.

A typical patient suffering from LDH

30-50 years old
Moderate disc degeneration
No improvement after 12 weeks of acute leg pain
Surgery is the only option

ALLEIVATES PAIN BY REDUCING THE SIZE OF THE HERNIA AND THE INFLAMMATION

THE TREATMENT IN SHORT
The treatment aims to target patients suffering from herniated discs. It is designed to decrease disc pressure by shrinking the hernia, leading to amelioration of pain. The volume and pressure of the intervertebral disc is decreased, and the disc is transformed into connective tissue. This decrease in both volume and pressure will cause disc hernia shrinkage, decreasing nerve pressure and relieving pain. Furthermore, the transformation into connective tissue will stabilize the disc, in turn lowering the risk of re-herniation.