Stayble Therapeutics is facing an eventful 2023 with expected data reporting from the phase IIb study with STA363. Patient recruitment was completed in 2022 and the six-month follow-up is predicted to be completed in the spring. In addition, the partnering discussions and preparations for phase III are now intensified. This includes a pre-IND meeting with the FDA, according to CEO Andreas Gerward.
Stayble Therapeutics develops the injectable treatment STA363 for patients with chronic disc-related back pain. STA363 transforms the disc into connective tissue, which potentially can reduce the patient’s pain – for life. The treatment is mainly aimed at those patients who do not respond to analgesics or physiotherapy, and who do not want to undergo spine surgery.
Results from the phase IIb study are approaching
Safety and effect on pain are currently being evaluated in a clinical phase IIb study that was initiated in 2020 and which was fully recruited in 2022. The study includes 110 patients who have received a dose of STA363 or a placebo. A follow-up period of 12 months is now underway and then the data will be compiled and analyzed. The goal is to present top-line results in Q4 2023.
After that, the next step is to initiate a phase III study together with one or more partners. In the event of positive study results in phase II, the next clinical phase could begin as early as the second half of 2024, according to an interview with Sara Richardson, Stayble’s VP CMC & Regulatory Affairs.
Upcoming milestones in 2023
For the next step in the development, Stayble Therapeutics will intensify the partnering activities and regulatory preparations, in parallel with the completion of the phase IIb study with STA363. BioStock talked to CEO Andreas Gerward about the expectations for 2023.
First of all, how would you describe Stayble Therapeutics’ development in 2022?
– 2022 has been a transformative but very positive year for Stayble. We managed to reverse a trend of slow patient recruitment to reach the highest screening as well as recruitment levels, which resulted in a fully recruited study in August. In parallel, we have attended several scientific and business conferences with great interest from potential partners and experts in the field. With a fully recruited study, we notice that partners’ interest is concretized and the discussions become more in-depth.
We managed to reverse a trend of slow patient recruitment to reach the highest screening as well as recruitment levels, which resulted in a fully recruited study in August […] With a fully recruited study, we notice that partners’ interest is concretized and the discussions become more in-depth«
– We also see positive trends linked to back pain with the FDA classifying back pain as a priority development area. In addition, more companies are taking an interest in hospital-based products.
What is the timetable until the reporting of top-line results from the phase IIb study in the fourth quarter of 2023?
– The last patient was recruited in August and then the patients are followed for 12 months. This means that the last patient will have their last follow-up in early September this year. After that, the patient follow-up is completed and all the clinics’ data is checked by our local partners, after which the database is locked. Then the code is broken regarding which patients have received active treatment or placebo. After that, top-line data is presented to Stayble. A month or so later, the final report will be published.
Are you planning to present any kind of study data before the full study results?
– We intend to provide the market with updates on the development of the study before top-line data. However, since the study is double-blinded, no data linked to STA363’s effect will be presented before Q4 2023.
A pre-IND meeting with the FDA is also on the agenda for 2023. Why is it important for your development plans in the US?
– The US is the most important market for us. Discussing our existing data and plans going forward with their regulatory authority will give us important insights into how we should design the upcoming clinical study and an overview of the approval path for a new drug.
– In addition to the FDA, we will also meet with the Swedish Medical Products Agency during the first half of 2023 for scientific advice for the European market. The Swedish Medical Products Agency has a very good reputation in Europe. Our discussions with them will provide a good understanding of how authorities in Europe reason in general.
»In addition to the FDA, we will also meet with the Swedish Medical Products Agency during the first half of 2023 for scientific advice for the European market. The Swedish Medical Products Agency has a very good reputation in Europe«
Last but not least, what can we expect in terms of partnering agreements for STA363 in 2023?
– During the year, Stayble will continue detailed discussions with several existing and new contacts to have as many actors as possible with interest in the results from our phase IIb study. However, it can take time to reach this type of comprehensive agreement and we will thus not have a final partnering agreement in place in 2023. But we will see which stakeholders we will prioritize for further negotiations, with the goal of concluding a partnering agreement in 2024.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.