Correction: Stayble Therapeutics publishes interim report for the third quarter of 2023November 2023 Regulatorisk
Republishes with MAR text in the press release. No changes have been made to the press release or the attached report.
Stayble Therapeutics AB (“Stayble” or the “Company”) hereby publishes its quarterly report for the third quarter of 2023. The report is available as an attached document and on the Company’s website, www.staybletherapeutics.com/en/investors/financial-reports/. Below is a summary of the report.
Highlights during the third quarter (July – September 2023)
- In July, Stayble announced that about 90% of the patients in the ongoing Phase IIb study for treating degenerative disc diseases have completed their twelve-month follow-up.
- In August, the first patient was included in the clinical Phase 1b study with STA363 to treat herniated discs. A total of 24 patients will be randomized and either treated with STA363 or placebo (2:1 distribution).
- In September, Stayble terminated the liquidity guarantee agreement with Lago Kapital AB.
- In September, Stayble announced that the last patient in the clinical phase 2b study for treating degenerative disc diseases had been completed. This means that the study's target number of evaluable patients has now been reached.
Highlights after the end of the period
- In November, Stayble announced top-line data from the Phase IIb study of STA363 for chronic disc-related back pain. The randomized, double-blind study did not meet the primary endpoint. According to the predetermined statistical criteria, STA363, compared to placebo, did not show a statistically significant reduction in pain after six months.
Financial information and commentary
No further comments.
Comment from the CEO
I have been involved in Stayble's journey from an idea to becoming a listed company with two indications in clinical phase. It has been an inspiring journey where we, as a company, have developed and grown over the years. It is, therefore, with disappointment that I can now state that we did not reach the goal with our indication within degenerative disc diseases. That a clinical study does not show the desired outcome is always a scenario, but you can never prepare for how it will feel when it does happen. It is disappointing for all patients who hoped for a new treatment, the shareholders, me personally, and everyone who works at Stayble. After these results, we change direction and look forward to the results of our second study within disc herniation, not least because we see indications in the data from the phase 2b study that support the primary mechanism of STA363. It is this mechanism that can provide a pain-relieving effect in herniated disc patients. We are also reviewing how we can drastically reduce our costs to have sufficient financial endurance to obtain results from the phase 1b study in the second indication without additional funding.
Results from the Phase 2b study
We, unfortunately, conclude that the phase 2b study did not achieve the primary efficacy objective of showing a statistically significant reduction in pain compared to placebo at either the six- or twelve-month follow-up. However, all three treatment groups showed a significant pain reduction after treatment. We assess that an expansion of the scope of the study would likely not result in any significant difference between the groups, at which point the study is therefore considered conclusive. STA363 showed a continued good safety profile for up to twelve months. The study's secondary efficacy measures regarding function and quality of life showed no significant differences between the two dose groups and the placebo group. In the high-dose group, however, the study showed a reduced water content in the disc, compared to the placebo group, which indicates increased connective tissue conversion. We continue to evaluate data from the study to understand the results better.
How do we proceed?
Based on preliminary analyses, the data from the phase 2b study strengthens our confidence that we will be able to show an effect on disc herniation in our ongoing phase 1b study. The data shows that disc height has decreased as expected in STA363-treated patients in the phase 2b study. A decrease in height is a measure of reduced disc volume. This change is crucial to achieving the pain-relieving effect we aim for in herniated disc patients. STA363's efficacy in reducing patients' pain in the two indications is different. In degenerative disc diseases, the goal is disc stiffness and reduced inflammation. In contrast, disc herniation treatment is based on reducing the disc volume and the hernia, thereby alleviating the patient's pain.
To enable continued development and give the company the necessary runway, we are now reducing the company's costs. This means, among other things, that the agreement with Ferghana Partners to support partner activities is paused, we review the organization's size and reduce external costs.
In conclusion, we at Stayble aim for every shareholder to clearly understand the differences between our two different indications. From now on, we will carefully analyze the data from the phase 2b study. We plan to update the market with more detailed information on all the data and explain why our belief in the potential of the herniated disc project still remains.
For more information
Andreas Gerward, CEO of Stayble Therapeutics AB
Phone: +46 730 808 397
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 14th, 2023.
About Stayble Therapeutics AB
Stayble is a clinical-stage pharmaceutical company developing the STA363 injection treatment for degenerative disc disease (DDD) and chronic disc herniation (LDH). Stayble's vision is to offer patients a simple and effective treatment that addresses the underlying cause of the patient's chronic pain and provides lasting pain relief and increased physical function. Aimed at patients who are not helped by physiotherapy and painkillers, the treatment is a single injection that is expected to last a lifetime and requires minimal rehabilitation. The company is now focused on clinical development and is conducting a Phase 2b clinical trial in DDD and a Phase 1b trial in LDH.
Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.