Just before Easter, Stayble Therapeutics presented positive interim data from 100 patients in the phase IIb study with STA363 for the treatment of degenerative disc disease. The interim analysis shows that the injection treatment is safe and that the pain measurements have a low dispersion, which is beneficial for the final data read-out at the end of the year. BioStock contacted the company’s CSO Anders Lehmann to learn more about the progress of the study.

Stayble Therapeutics’ drug candidate STA363 has the potential to alleviate pain in patients’ suffering from degenerative disc disease and chronic herniated disc. The treatment addresses the underlying cause of the pain and can thereby provide lasting pain relief and increased physical function.

Ongoing phase IIb study

Since 2020, the company is conducting a phase IIb study to evaluate STA363’s efficacy and safety in patients with degenerative disc disease. Approximately 70 per cent of all patients have completed their twelve-month follow-up, which is the last follow-up. The company’s goal is to present top-line data in the fourth quarter of 2023.

Additional positive interim data presented

100 patients have completed their six-month visit and Stayble has thus been able to conduct an interim analysis based on blinded data from these patients. On April 5, the company announced that the results show good safety and tolerability and that no serious side effects have been observed.

Already in November 2021, Stayble reported promising interim data from the study, which the company’s CEO Andreas Gerward talked more about in an interview. Now they have presented additional data that further support that STA363 is a safe treatment and that the study is being conducted in a favorable way:

»The fact that we once again can present positive interim data and now from around 100 patients, which is the inclusion goal in the study, is a very important milestone in our development. The positive interim results demonstrate a well-planned study and that we and our dedicated investigators and collaborators have been successful in obtaining the most reliable data possible.« – Andreas Gerward, CEO Stayble Therapeutics

Low dispersion in pain measurements

In addition to safety, the analysis shows a lower variation than expected in the measurement of pain, which may be due to the initiatives that Stayble has implemented to improve pain measurement and increase reliability.

For example, the company works actively in educating patents and involved doctors and staff. Furthermore, they record pain digitally for seven days at each follow-up time to get an accurate experience of the pain and reduce the risk of external factors. According to the company, this approach can reduce variability and increase the likelihood of a conclusive outcome of the study.

CSO Anders Lehmann tells us more

One person who is highly involved in Stayble Therapeutics’ clinical development is the company’s CSO Anders Lehmann. BioStock contacted Anders to find out more about the interim analysis.

How does this interim analysis differ from the one conducted in November 2021?

– In the previous analysis, fewer patients had been treated and now all have received their treatment as planned. The larger amount of data means that the reliability is significantly higher.

»Now all have received their treatment as planned. The larger amount of data means that the reliability is significantly higher.«

The data shows good safety and tolerability – what does that mean in more concrete terms?

– Half of the patients reported mild or moderate side effects. A total of 91 adverse events were reported, but only 17 of these were considered related to the treatment. All of these had to do with transient pain, which is expected after a disc injection. Two patients reported serious adverse events, but they were not considered to be caused by treatment. For example, a patient was diagnosed with prostate cancer. It is of course very unlikely that it would have causality with a disc injection.

In the press release, you also mention that a low spread in the pain measurement can give good opportunities for conclusive outcome of the study. Could you explain your reasoning here?

– Differences in outcomes between treatment groups may be impossible to detect statistically if the spreads are too large. Conversely, outcomes with averages close to each other and low spreads indicate that the treatment has no effect. When calculating how many patients you need to include in a study, two factors are crucial: the expected difference in outcomes between placebo and active treatment and the expected spread. We used spread data reported from other studies like ours, and since those spreads were higher than the ones we have seen, the reliability of our results is higher.

You also write that there is a low drop-out rate of patients in the study. How many patients have left the study and why?

– Only 4 out of 109 treated patients have left the study for the following reasons: Other medical event (1), other non-medical event (2) and major deviation from the study protocol (1). We thought that about 10 patients would drop out, so the combination of low spread and slightly more evaluable patients than expected strengthens our conviction that we will get reliable results.

»The combination of low spread and slightly more evaluable patients than expected strengthens our conviction that we will get reliable results.«

What happens next in the study?

–  We closely follow the patients who are still in the study. Now a new phase also begins where we prepare so that all the data can be processed quickly and with high quality on the day the last patient makes their last follow-up visit. We, like many others, are very eager to see the end result, so when the database is complete and quality reviewed, all the pieces should be in place to be able to do a quick analysis.

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