Stayble Therapeutics' STA363 receives positive phase 1b 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.

Data show a statistically significant volume-decreasing effect compared to placebo already after 1 month, with a maximum reached after 3 months with a sustained decrease at the 6-month follow-up. These results correlate with previously generated data from the phase 2b STA363 study in Degenerative Disc Disease and add valuable insights regarding the onset of volume changes. Moreover, the STA363-induced disc volume reduction is similar to what is available in publications, which correlates to a significant pain-relieving effect in patients with herniated discs.

Improvements in pain scores, functionality, and overall satisfaction were demonstrated in both groups. The study was not powered to detect a difference between the STA363-treated and placebo-treated patients; hence, this result is entirely in line with the study's expectations.

CEO Andreas Gerward, comments

I am thrilled to present positive results from our study, with the results meeting the primary endpoint in establishing an acceptable safety and tolerability profile. In addition, I am excited that the results clearly demonstrate a STA363 effect on the disc as intended, with statistically significant changes in volume at all follow-up visits, i.e., an effect already after 1 month. This finding may indicate that we will be able to demonstrate an effect on the many times excruciating pain that patients with disc herniation suffer from when we continue the development of STA363 in LDH patients. We have gained important knowledge on efficacy endpoints, setting a solid foundation for the next phase of development. With these results supporting further development, we look forward to advancing preparations for a phase 2b study and intensifying our partnering activities. Finally, I would like to thank our team, collaboration partners, and shareholders for their dedication, support, and persistence.

For more information

Andreas Gerward, CEO of Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808397

This information is the type of information that Stayble Therapeutics AB is obliged to publish pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on November 13, 2024.

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 relieving pain. Treatments that reduce disc and hernia volume have been shown to reduce nerve root pain caused by herniated discs. [1],[2], [3]

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.

[1] Splendiani et al. MR assessment of lumbar disk herniation treated with oxygen-ozone diskolysis: the role of DWI and related ADC versus
  intervertebral disk volumetric analysis for detecting treatment response. 2013

[2] Bitz et al. An evaluation of narrowing following intradiskal injection of chymopapain. 1977

[3] Murphy et al. Percutaneous Treatment of Herniated Lumbar Discs with Ozone: Investigation of the Mechanisms of Action. 2016