Stayble Therapeutics reports additional data strengthening the STA363 treatment for pain caused by disc herniation

Stayble Therapeutics AB ("Stayble" or the "Company") has previously announced positive results from the Company's clinical phase 1b study in lumbar disc herniation (LDH). The study met its primary safety and tolerability endpoint. Additional data exhibit several positive outcomes, including a promising statistically significant reduction in disc volume compared to placebo-treated patients, and further analysis has generated key learnings regarding MRI changes that give STA363 critical competitive advantages.

CEO Andreas Gerward, comments
The additional analysis strengthens our belief in STA363 and its potential to relieve pain caused by disc herniation in the coming development. The phase 1b trial has shown a statistically significant effect in terms of volume changes. It demonstrates a very good correlation to previous data regarding disc height, giving us a good understanding of the long-term effects of STA363 and adding valuable safety information. An important differentiating factor compared to our competitors is the convincing data that none of the 100 STA363 injections performed induces or exacerbates negative effects on the endplate and vertebra, so-called Modic type 1. We are in a very exciting situation in developing STA363 as a safe product with an apparent effect on volume change, which is the foundation for treatments that decrease pain. I'm looking forward to the next step in development and to continuing to present these promising clinical results to key partners.

Introduction

In total, 25 patients were included in the trial, with 17 patients treated with STA363 and 8 treated with a placebo. The mean age was 38 years old. All injected discs had moderate disc degeneration, and all injections were performed in the lower spine. The study was primarily aimed at assessing the safety and tolerability of STA363. The key secondary endpoint was to test the hypothesis that STA363 reduces the disc volume of the herniated disc. A reduced disc volume should decrease the size of the hernia and the pressure on nerve roots, thereby relieving pain. Additional analysis of secondary morphological changes was conducted to evaluate STA363's safety on the disc. Among morphological changes, Modic type 1[1], which is significantly associated with low back pain, was the most interesting to study since this is a safety concern for our competitors.

Results
The study met its primary endpoint with an established favorable safety profile. Only a few adverse events (AE) and no sustained serious adverse events (SAE) related to STA363 were recorded during the study.

MRI assessment was the key secondary endpoint with measurements of volume, height, and other morphological changes.

• The disc volume at the start of the trial was, on average, 14.4mL in the placebo group and 12.6mL in the STA363 group. The average decrease at 1, 3, and 6 months was -0.20, -0.34, and -0.39mL in the placebo group and -0.86, -1.40, and -1.53mL in the STA363 group. The difference towards placebo was statistically significant compared to placebo with a p-value at 1 month of 0,08 and below 0,05 at 3 and 6 months after treatment.

• Disc height measurements demonstrated a statistically significant difference towards placebo at 3 and 6 months with a p-value of 0,05 or lower. The difference after 6 months correlated very well with previous data gathered from the phase 2b trial targeting degenerative disc disease.

• Additionally, analysis of secondary endpoint data showed that treatment with STA363 exhibited no unwanted morphological changes. Existing Modic changes, significantly associated with low back pain (n=4 (placebo) and n=7 (STA363)) did not change during the study, nor did the prevalence of Modic changes increase. STA363 has been injected in 100 patients, and data clearly show that STA363 does not induce any Modic type 1 changes.

For more information

Andreas Gerward, CEO of Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808 397

About the clinical STA363 phase 1b study

The study "A Prospective, Randomized, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients with Radiculopathy Caused by Lumbar Disc Herniation", was a multicenter, double-blind, placebo-controlled study in 25 LDH patients conducted at three sites in Poland. Patients were randomized to either treatment with STA363 or placebo with a ratio of 2:1. All patients received a single injection of STA363 or placebo and were followed for 6 months with follow-up visits at 1 week, 1 month, 3 months, and 6 months. MRI was performed at screening, 1, 3 and 6 months to gather valuable objective measurements regarding safety, volume changes and type of herniation. The study was primarily aimed at assessing the safety and tolerability of STA363, and secondly, the hypothesis that STA363 reduces the disc volume of the herniated disc was tested. A reduced disc volume should decrease the size of the hernia and the pressure on nerve roots, and thereby relieve pain. Treatments that reduce disc and hernia volume have been shown to reduce nerve root pain caused by herniated discs. [2],[3], [4]

About Stayble Therapeutics AB

Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for lumbar disc herniation (LDH). Stayble's vision is to offer patients a simple and effective treatment that targets the underlying cause of the patient's chronic pain and provides lasting pain relief and increased physical function. The treatment is aimed at patients who are not helped by physical therapy and painkillers and is a single injection that is expected to last a lifetime and requires minimal rehabilitation. After convincing data from previous pre-clinical and clinical studies (phase 1b and 2b) in degenerative disc disease, which show a volume reduction of the discs, the Company has successfully completed a phase 1b study for the treatment of herniated discs.

The company's Certified Adviser is Svensk Kapitalmarknadsgranskning AB.