2023 has been an eventful year for Stayble Therapeutics with positive interim data from the study in degenerative disc disease, a rights issue, launch of disc herniation as new indication and successful partnering discussions at the Bio International Convention in Boston. The company has also recruited two new key players to the team, Dr. Jarkko Kalliomäki and Professor Daisuke Sakai. However, this is only the beginning of 2023, which could be the most important year so far for the company, according to CEO Andreas Gerward.
Stayble Therapeutics is a clinical-stage pharmaceutical company developing the drug candidate STA363 for degenerative disc disease (DDD) and chronic disc herniation (LDH). STA363 is a simple and effective injection treatment that addresses the underlying cause of the patient’s pain by transforming the disc to connective tissue.
The company is currently conducting a phase IIb study with STA363 in degenerative disc disease and they have also received approval to start a phase Ib study in herniated discs. The herniated disc study was launched earlier this year and Stayble is now preparing to start patient recruitment.
Eventful first quarter
The launch of a new indication has been one of the most important events so far in 2023. In the company’s Q1 report, Stayble also highlights the positive interim data from the phase IIb study showing good safety and tolerability with STA363, and low variation in pain data from the six-month follow-up.
The study continues with a low drop-out rate. All patients have completed their six-month follow-up, which means that the company has secured all critical data required to evaluate the study’s primary efficacy parameter. Top-line results from the study are expected in the fourth quarter of 2023.
Funded for the journey ahead
Stayble reports an operating loss of -3.8 MSEK for the first quarter and a cash balance of 6.2 MSEK at the end of the period. However, the company has since strengthened its cash position by 31.7 MSEK through a rights issue that was subscribed to circa 90 per cent, including subscription and guarantee commitments.
During the spring, Stayble has also expanded the management team with Jarkko Kalliomäki as Chief Medical Officer. Kalliomäki has research experience in pain physiology and has been a specialist in pain management for 25 years. He has worked with many different clinical pain conditions, not least chronic back pain. In an interview with BioStock, Kalliomäki explained that chronic back pain is one of the dominant causes of suffering, reduced quality of life and work ability and that there is a great need for causal treatment.
Stayble has also strengthened its Scientific Advisory Board with Professor Daisuke Sakai, Associate Professor in the Department of Orthopaedic Surgery at Tokai University School of Medicine in Kanagawa, Japan. Sakai will contribute his experience and expertise in degenerative disc disease and herniated discs, as well as a clinical perspective from the Japanese market.
Partnering events and other important activities
Stayble is now preparing for more important activities during the rest of the year, such as treating the first patients in the herniated disc study and presenting top-line data from the study in degenerative disc disease. These will be the first efficacy results for STA363 and could potentially be crucial for further development.
In 2023, the company also plans to continue the ongoing partnering dialogues and create new contacts by attending partnering events. On June 5-8, Stayble attended the BIO International Convention in Boston, the largest partnering conference in biotechnology and pharma with over 14,000 participants. During the convention, Stayble had about 30 meetings with global and local companies from Europe, the US, Japan, South Korea, and China. The goal of the conference was to follow up ongoing discussions and introduce STA363 to new potential partners with the capacity to take the drug candidate to phase III and market approval.
CEO Andreas Gerward comments
BioStock contacted CEO Andreas Gerward to find out more about the plans going forward and why 2023 is such an important year for Stayble.
In the report for the first quarter, you mention that 2023 will be the most important year in Stayble’s history so far, why?
– Since we started Stayble in 2014/2015, we have been driven by the goal of showing that our concept actually provides the pain relief we believe it does in humans. In Q4, we know the answer.
– The fact that we will also treat the first patients in the herniated disc study makes the year really exciting.
»Since we started Stayble in 2014/2015, we have been driven by the goal of showing that our concept actually provides the pain relief we believe it does in humans. In Q4, we know the answer. The fact that we will also treat the first patients in the herniated disc study makes the year really exciting.«
What have you learned from the phase IIb study in degenerative disc disease that may be useful in the upcoming phase Ib study in herniated discs?
– I would like to highlight patient recruitment and the understanding of what the patient flow looks like at our clinics.
– We also take with us that it is important to involve several clinics as we clearly see that if you find a few committed clinics, the implementation will be very smooth.
– Knowledge about the placebo effect and how to work to reduce it.
– And finally, our improved ways of measuring disc volume using MRI
Where are you currently in the two studies?
– In our phase IIb study, we are in the final phase of patient follow-up where the last patient follow-up is expected to take place in late August or early September this year.
– In our phase Ib study, we are now in an intensive preparation phase where we are working with clinic agreements, manuals, building our electronic data collection system, preparing to be able to easily take care of magnetic camera images, logistics around the delivery of substances and mixing material and more. The goal is to treat the first patients during the third quarter of this year.
»In our phase IIb study, we are in the final phase of patient follow-up where the last patient follow-up is expected to take place in late August or early September this year. In our phase Ib study, we are now in an intensive preparation phase«
Finally, what experiences do you take home from the BIO International Convention in Boston?
– We have received confirmation that we have an interesting product and that phase IIb data is what many potential partners are looking for. During the congress, we had about 30 meetings and met companies from Europe, USA, Japan, South Korea, and China, all of which are interested in our concept. We are looking for both global and local players. The important thing is that a partner should have the right development capacity as well as the right commercial capacity and knowledge of the dynamics of the geographic markets in which they operate.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.