Stayble’s phase IIb study nears the finishing line
Stayble Therapeutics’ clinical phase IIb study with STA363 takes no break in the summer heat. Approximately 90 per cent of the patients have now completed their 12-month follow-up, which shows that the company has good opportunities to present top-line data during the fourth quarter of this year. The company’s CEO Andreas Gerward tells us more in an interview.
Stayble Therapeutics is a clinical-stage pharmaceutical company developing the injection treatment STA363 for patients suffering from degenerative disc disease (DDD) and chronic disc herniation (LDH). The goal is that just one injection of STA363 will relieve the pain and lead to increased physical function.
STA363 is currently being evaluated in a clinical phase IIb study in degenerative disc disease, as well as a phase Ib study in herniated discs.
The study is progressing – low dropout rate
The phase Ib study is currently in the start-up phase, while the phase IIb study is in its final stage. In February, 100 patients had completed their six-month visit in the phase IIb study. Today, approximately 90 per cent of the patients have completed the twelve-month follow-up, which is the last follow-up. In addition, the number of patient dropouts in the study remains low. In April, only four patients had left the study, according to an interview with CEO Andreas Gerward.
Pain reduction is the goal
The phase IIb study evaluates the efficacy and safety of two concentrations of STA363 (60 and 120 mg/ml) compared to placebo. The primary objective of the study is to demonstrate statistically significant and clinically relevant reduced pain. The patient’s pain is measured by a numerical rating scale (NRS) between 0 (no pain) and 10 (extreme pain). In addition to pain, the patient’s physical function and changes in the spinal disc are measured on MRI images.
The hope is that the MRI images will show that STA363 has converted the disk into connective tissue, which is the purpose of the treatment.
Interim data from the study show good safety and tolerability, as well as a low variation in pain measurements between different clinics – which increases the chances of a conclusive study outcome.
CEO Andreas Gerward comments on the milestone
BioStock contacted CEO Andreas Gerward to find out more about the strategy for obtaining as reliable data as possible.
90 per cent of the patients have now completed the twelve-month follow-up in the phase IIb study. What does this mean for the study schedule?
– This means that we are fully in line with our schedule and that results will be presented during the fourth quarter as previously communicated.
In the study, the patient’s pain is measured using a subjective, numerical rating scale. How do you use the self-assessment scale in relation to MRI and the results from them?
– For patients, the most critical thing is to achieve pain relief. The goal is that this can be achieved by stabilising the spinal disc and eliminating possible leakage of inflammatory substances. It is important to emphasise that even minor changes, which may not be immediately noticeable on an MRI scan, can have a noticeable impact on the patient’s discomfort. Thus, there is no direct relationship between the amount of transformed connective tissue in the disc and the degree of pain a patient experiences. The goal of our therapeutic interventions is not necessarily to maximise the transformation of connective tissue, but rather to stabilise the spine and eliminate leakage. These goals can often be achieved with only a certain degree of transformation, but with a maximised pain relief as a result.
How do you reduce the risk of placebo effect in the study?
– We work actively throughout the study with training of study staff and patients to understand how placebo works, its impact and what can be done to reduce it. From the study staff’s perspective, it is important to remember that it is a clinical study and thus to be relatively neutral in their treatment, but also to think about what is said to the patient.
– To further ensure more reliable results, we have implemented a pain measurement protocol. Instead of measuring pain intensity at a single point in time, we perform pain measurements over seven days. This reduces the risk of getting distorted data by measuring pain on an unusually good or bad day for the patient. This gives us a more fair and accurate estimate of the patient’s average pain level, which provides more reliable data.
Finally, you hope to be able to present topline data from the study in Q4. What else can we look forward to in Stayble Therapeutics over the next six months?
– In addition to our phase IIb study, the focus is on running our phase Ib study in herniated discs, where the first treated patient is the closest milestone. In addition to phase Ib, we will continue our intensive data partnering work.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
