In 2021, Stayble Therapeutics made progress in the development of a disease-modifying injection treatment for chronic discogenic low back pain. During the year, Stayble Therapeutics was strengthened with the recruitment of several key persons and an oversubscribed share issue. Finally, they were able to present positive interim results from the phase IIb study with STA363. BioStock contacted CEO Andreas Gerward to get his thoughts on the past year and what to expect next.
Stayble Therapeutics drug candidate STA363 removes the underlying causes of chronic discogenic low back pain. This is different from traditional treatment with physiotherapy and pain relievers that focus solely on alleviating symptoms. The ambition is that only one injection of STA363 will be necessary to provide permanent pain relief. The candidate’s treatment effect is currently being evaluated in a phase IIb study conducted at clinics in Russia, the Netherlands and Spain.
2021 was another eventful year
Since Stayble Therapeutics was founded in 2015, they have managed to take STA363 from the idea phase, through preclinical studies and a phase Ib study, to now being tested in a phase IIb study. With each passing year, the company has made significant progress in the development process, including in 2021.
Welcomed additions to the organisation
The past year began with the company strengthening its scientific advisory board with two members – Dr. Aaron Calodney and Dr. Douglas Beall, both based in the United States. The two new members bring solid expertise in pain relief and back diseases, as well as extensive knowledge of the US market, which is a key market for Stayble Therapeutics. About two months later, Stayble Therapeutics’ scientific advisory board was expanded with another member, Professor Hans Jörg Meisel from Berlin, who adds expertise in clinical trials in degenerative back pain.
It was not only the scientific advisory board that was strengthened in 2021, the management team also received a welcomed addition through the recruitment of Dr Sara Richardson. In her role as VP CMC and Regulatory Affairs, Richardson works with manufacturing issues (CMC), regulatory issues and interactions with authorities – key aspects for the continued clinical development of STA363.
Oversubscribed rights issue
Also, the company’s finances have been strengthened this year thanks to a rights issue that was carried out inFebruary, which was subscribed to 268 per cent. As a result, the company received 41.5 MSEK before issuecosts that will finance the completion of the phase IIb study, processing of the study results and discussionswith potential partners for further development of STA363.
In July, BioStock interviewed Jane Buus Laursen, board member of Stayble Therapeutics, about the search for the right partner for the company. Read the interview here.
Promising interim data from the phase IIb study provide momentum
In the beginning of November, Stayble Therapeutics presented positive interim results from the ongoing phase IIb study indicating good safety and tolerability, as well as a high probability for a conclusive outcome. No serious adverse events (SAEs) were reported, further confirming STA363’s favourable safety profile. The results also showed a low variability in the pain measurements between the different study clinics, thanks to a pain measurement method that registers the patient’s pain for seven days per follow-up. This method increases the chances of accurate pain measurement, which reduces the spread in pain data and increases reliability.
The positive results drive the company to continue the clinical development towards the goal of developing atreatment for millions of patients suffering from chronic discogenic low back pain:
»We continue to work on the patient recruitment for our ongoing phase IIb study. The positive interim results give us further impetus to develop a treatment option that can help people with chronic back pain«— Andreas Gerward, CEO Stayble Therapeutics, from the company’s Q3 report.
The effects of the pandemic on patient recruitment
The interim results imply that the phase IIb study can be continued without restrictions. However, patient recruitment is taking longer than expected due to the Covid-19 pandemic.
As with many other companies, the pandemic has had an impact on Stayble Therapeutics’ clinical work. At the moment, patient recruitment is affected by the high infection rate in Russia, where a large proportion of patients in the phase IIb study will be recruited. The top-line results will not be presented until 2023, instead of the second half of 2022. However, the delay does not give rise to an increased need for capital according to the company.
Stayble Therapeutics CEO optimistic about 2022
In order to maintain as high a recruitment rate as possible, resources will be allocated to areas with lower spread of Covid-19. In addition, the company are continuously investigating possibilities for speeding up recruitment in a safe way.
BioStock contacted Stayble Therapeutics’ CEO Andreas Gerward to hear his thoughts on the past year and the plans ahead.
Andreas, how would you sum up 2021 in three words?
– Positive, preparatory and strengthening are three key words that I will take with me from 2021. The word positive comes from the interim data we presented at the beginning of November. By preparatory, I mean that 2021 has been a “middle year” where no final study results have been presented, but it has nevertheless been an important year with preparatory activities for the further development of STA363. Strengthening refers to the fact that we have expanded the organisation and are now ready for what the future has to offer.
How confident are you about the continued development of STA363 given the interim results from the phase IIb study?
– We feel confident about the continued development as the interim data from the phase IIb study show high quality in the study implementation and high probability for a conclusive outcome. We also feel confident with the good safety profile that our candidate has shown so far and see no reason why this would change in the future.
»We also feel confident with the good safety profile that our candidate has shown so far and see no reason why this would change in the future.«
– In addition, we are well funded for the implementation of the phase IIb study with STA363. We believe that we will not need to raise more capital to complete the study.
How will you work to identify potential partners for phase III studies and market in 2022?
– A combination of attendance at relevant partnering conferences, active direct contacts with specific companies and continuous touch base with existing stakeholders. Furthermore, we will continue to maintain close contact with Key Opinion Leaders and attend scientific congresses, which are important components in increasing our visibility and being able to arouse and maintain interest in our innovation among the scientific expertise.
What can we expect from Stayble Therapeutics in 2022?
– In 2022, we will continue the patient recruitment for the phase IIb study with the goal of recruiting the lastpatient during the year (Last patient in). We will also continue to update the market on our candidate’s safety and tolerability. In addition, we will attend and present at a number of scientific congresses, partnering events and retail events.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.