Staybe Therapeutics sees optimism amongst study clinics
During 2020, Stayble Therapeutics, despite the Covid-19-pandemic, managed to initiate a phase IIb study with its candidate STA363 in all the countries intended to be included in the study. The company also carried out an IPO and a successful issue which was subscribed to 436 per cent. In addition, the results from Stayble Therapeutics’ studies with STA363 were published in Spine, a leading scientific journal in the area of spinal research. BioStock has contacted Stayble Therapeutics’ CEO Andreas Gerward to find out more about the past year and the company’s plans for 2021.
Stayble Therapeutics’ main focus during 2020 was primarily the initiation of a phase IIb study with STA363, an injection treatment for discogenic back pain.
The study is now fully initiated and will include a total of circa 100 patients at 20 clinics in the Netherlands, Russia, and Spain. The main aim of the study is to show that STA363 treatment leads to a clinically significant reduction in pain in patients with discogenic back pain.
Considerable interest in the IPO
In March, Stayble Therapeutics’ shares were listed on Nasdaq First North Growth Market. In connection with the listing, a successful issue was carried out which was subscribed to 436 per cent. The company’s CEO Andreas Gerward was very pleased with the outcome:
»We are considerably strengthened by the great interest from investors in our new issue of SEK 35 million, which was oversubscribed with over SEK 150 million by over 4,000 interested investors. We are grateful for the confidence shown by the market which enables the start of the phase IIb clinical trial in Q2 2020« – Andreas Gerward, CEO of Stayble Therapeutics
The issue was primarily carried out in order to secure the start of the clinical phase IIb study with STA363.Since the IPO, Stayble Therapeutics has reached significant milestones in the development of STA363. The company has done this despite global concerns related to the Covid-19 pandemic.
Started phase IIb study in 2020
In the spring, Stayble Therapeutics received the regulatory approvals required to start the study in the Netherlands, Spain, and Russia. In mid-June, the company announced that the first clinic in Russia had been initiated, and a month later, the company had also initiated the first clinic in the Netherlands.
»The initiation of the trial according to plan during Q2 despite the challenges of the Covid-19 pandemic is a great achievement of our team and our collaboration partners. « – Andreas Gerward
At the end of July, Stayble Therapeutics was also able to announce that the first patient had been treated in the study, which was an important milestone for the company and one they had been working hard towards.
It took until October before the news came that the study had been initiated in Spain. The delay in Spain was due to the fact that the country has been hit hard by Covid-19, which in turn has led to extensive restrictions and limited access to healthcare to conduct clinical studies.
Publication in Spine – important external validation and seal of quality
In early October, Stayble Therapeutics’ study results were published in Spine, the leading scientific journal for research on back pain. The article in Spine included results from the company’s preclinical studies which show that lactic acid, which STA363 consists of, leads to proliferation to connective tissue in the disc. This is the desired biological effect in order to be able to stabilise the disc segment and reduce the back pain.
The article also mentioned the results from the company’s phase Ib study which concluded that the treatment is safe and tolerable. The fact that the study results have been published in Spine, one of the highest-ranked journals within the company’s research area, is an important external validation for Stayble Therapeutics’ research and drug development. In addition, the publication is proof that the company is on the right track, but it is also an asset in future discussions with potential partners.
Presented at a big scientific congress
In October, Anders Lehmann, Chief Scientific Officer of Stayble Therapeutics, gave a presentation at EuroSpine Annual Meeting, one of the largest international scientific congresses in the field of back research.
Stayble Therapeutics chose to attend the congress to present the company’s research and to discuss it with the international expertise. Only 7 per cent of the submitted contributions were selected for oral presentations at the conference, which shows that there is significant interest in Stayble Therapeutics’ treatment concept.
Participated in BIO-Europe to identify future partners
Later in October, Stayble Therapeutics participated in a digital version of BIO-Europe, the largest life science partnering conference in Europe. Mattias Münnich, the company’s VP Business Development, told BioStock that the aim of the company’s participation in the conference was to spread knowledge about STA363 and how the product can complement potential partners’ product portfolios.
»Building relationships early and letting companies follow us over time is important to speed up the process of a future deal when that time comes.« – Mattias Münnich, VP Business Development Stayble Therapeutics
During the event, Stayble Therapeutics focused on large and medium-sized pharmaceutical companies with an interest in orthopedics and/or pain. An overall purpose of all discussions was to draw the attention of the pharmaceutical companies to the great therapeutic need that exists in discogenic back pain and how STA363 is positioned to fill this void.
The future plans for STA363
In 2020, Stayble Therapeutics succeeded in initiating the phase IIb study with STA363 in all the countries that are intended to be included in the study – the Netherlands, Russia, and Spain – despite challenges related to Covid-19. The ongoing phase IIb study is now fully initiated and a wide-ranging recruitment of patients is currently being carried out.
Patients will be treated with a low or high dose of STA363 or placebo and will then be followed up for 12 months. Stayble Therapeutics has previously stated that top line results from the study will probably be presented during the first half of 2022.
Rights issue to ensure the completion of the phase IIb study
To finance the completion and processing of the study results of the phase II-study, Stayble Therapeutics has decided to carry out a rights issue of approximately SEK 41.5 million before issue costs during the first quarter of 2021. The raised capital will also be used to initiate discussions with potential partners who has the financial resources to take the project through phase III clinical trials to market approval.
BioStock has contacted Stayble Therapeutics’ CEO Andreas Gerward to find out more about the plans for 2021 and the past year.
First of all Andreas, how would you describe the year 2020 for Stayble Therapeutics and what events do you want to highlight?
-2020 was a very eventful year for Stayble. With so much else happening during the year around the world, it feels like the year lasted for much longer.
– It is almost as if one cannot understand that we at this time last year worked intensively with preparations for both the IPO that took place in March 2020 and the start of the phase IIb study thereafter. These two milestones I would say are the two most distinctive and significant events for the company to date.
Despite the pandemic, Stayble Therapeutics has succeeded in starting up the phase II study with STA363. What is the status of the study at the moment?
– We want to be able to show that STA363 is effective, safe, and easy to use in patients with low back pain. Each patient in the phase IIb study will receive a single treatment and will then be followed for 12 months to better understand the long-term effects of STA363.
– During the autumn, the phase IIb study started in all three study countries, the Netherlands, Russia, and Spain, with patient recruitment as a first step. Nearly all 20 clinics where the study will be conducted are now initiated. Of course, we see an impact on the processes as a result of the Covid-19 pandemic, especially in countries with stricter restrictions. However, we see signs of optimism among the clinics, particularly after positive vaccination news. We now look forward to working further with a wide-ranging patient recruitment in 2021.
» We see signs of optimism among the clinics, particularly after positive vaccination news. We now look forward to working further with a wide-ranging patient recruitment in 2021.«
Finally, what are Stayble Therapeutics’ plans for 2021?
– We are optimistic about the future and continue to keep our eyes fixed on our long-term goal of licensing STA363 to the right partner, a pharmaceutical company with strong resources that can take the final steps in the development to reach market launch. In 2021, the focus will be on continuing the implementation of our phase IIb study, which aims to confirm the effect of STA363 in patients suffering from low back pain.
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