In Stayble Therapeutics’ half-year report, the company’s CEO Andreas Gerward describes 2022 as a successful year so far. Patient recruitment to the phase IIb study with STA363 is progressing at a rapid pace and the last patients are expected to be recruited shortly. In addition, the company plans to intensify partnering activities during the autumn and prepare for the regulatory process in the US, the company’s most important market. Gerward tells us more about the plans and his views on the first half of 2022.
Stayble Therapeutics develops the injection treatment STA363, which focuses on the underlying causes of discogenic chronic back pain, also called degenerative disc disease. Only one injection of STA363 into the degenerated disc is expected to provide a permanent reduction in pain and increase movement function in patients. Read more about the benefits of the treatment here.
The efficacy of STA363 is currently being evaluated in a phase IIb study that will include a total of approximately 100 evaluable patients. Interim data from the study show that the treatment is safe and no negative side effects have been found so far.
For the first half of the year, Stayble reported an operating loss of 14 MSEK and a negative cash flow of 13,4 MSEK, where the increased costs are linked to the intensified patient recruitment during the spring. The cash balance on the balance sheet date amounted to 24 MSEK.
Study soon fully recruited
At the end of April, the company announced that 75 per cent of the patients had been recruited to the phase IIb study with STA363. Thanks to several efforts to increase the recruitment rate, the company is now well on its way to recruiting the last patients for the study. This is in line with the timetable to complete the recruitment in 2022 and present study results in the second half of 2023.
In the company’s half-year report, CEO Andreas Gerward says that he looks forward to achieving these milestones:
»The last patient to be included in the study, and then the results will be incredibly important milestones for Stayble and something that I look forward to being able to communicate to the market.«
Intensifying partnering efforts during the autumn
The company’s focus in the coming months will mainly be the recruitment of the last patients for the study. The company also plans to increase its exposure to potential partners for the continued journey towards market approval by participating in partnering conferences such as LSX Nordic Congress in Copenhagen, Nordic Life Science Days in Malmö and BioEurope in Leipzig during the autumn.
In addition, Stayble intends to initiate the regulatory preparations to conduct a phase III clinical trial with STA363 in the US. One of the first steps is a pre-IND meeting with the FDA to discuss the drug candidate and development plans.
Read more about the regulatory path to phase III and market in an interview with Sara Richardson, VP CMC & Regulatory Affairs in Stayble Therapeutics.
Andreas Gerward sums up and looks to the future
BioStock contacted Stayble’s CEO Andreas Gerward to find out more about the plans during the autumn and the progress during the first half of 2022.
How would you sum up the first half of 2022 in three words?
– Transformative, terrifying but successful for Stayble.
In the Q2 report, you mention that 2022 has been successful so far and that you are on a positive trend. Could you elaborate on how you think here?
– During the course of the study, we have struggled with a pandemic and challenges in patient recruitment. With a clearly reduced impact of Covid, and that we implemented several activities together with our investigators in the study, we have during the first half of the year reached an all-time high in recruitment rate and the number of treated patients per month.
– With a study soon fully recruited, we can begin to shift the focus from patient recruitment to the next step in the company where meeting with partners and the FDA is first on the list of activities. I am really looking forward to the next step in Stayble’s journey.
»With a study soon fully recruited, we can begin to shift the focus from patient recruitment to the next step in the company where meeting with partners and the FDA is first on the list of activities. I am really looking forward to the next step in Stayble’s journey.«
How has the recruitment rate developed since you updated us in May?
– We have continued to have a high recruitment rate throughout the summer and expect that the study will soon be fully recruited.
Looking ahead – what can we expect from Stayble during the autumn?
– The focus is on recruiting the last patients. When the last patient is in, the timeline until the top-line data becomes clear and we will intensify partnering activities during the autumn. Furthermore, we will have a meeting with the FDA which is an important step to understand the requirements and path forward towards clinical studies in the US and later a market approval.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.