Progress for Stayble Therapeutics in the second quarter
The second quarter was an intense period with several important achievements for the Gothenburg-based pharmaceutical company Stayble Therapeutics. After a successful capital raise, the company can run the two ongoing studies with STA363 at the desired pace. According to the plan, the phase IIb study in degenerative disc disease will be completed in the second half of 2023. The company also looks forward to treating the first patient in the phase Ib study in herniated discs.
Stayble Therapeutics develops the injection treatment STA363 for degenerative disc disease and chronic disc herniation. The drug candidate is based on an endogenous substance, lactic acid, which is given as a single injection into the disc. The company’s goal is that only one treatment should provide lifelong pain relief and increased quality of life.
The company is currently conducting a phase IIb study in patients with degenerative disc disease and initiating a phase Ib study in herniated discs.
Strengthened cash position after rights issue
On August 22, Stayble Therapeutics published the report for the second quarter in which they report an operating profit of -6.87 MSEK and a cash balance of 25.6 MSEK at the end of the period.
The company strengthened its cash position during the quarter through a rights issue that was subscribed for a total of approximately 90 per cent and which provided SEK 31.7 million before issue costs. The capital injection secures financing of the company’s two ongoing clinical studies and preparations for partnership.
Progress in the phase IIb study
In the beginning of the second quarter, Stayble announced positive interim data from the ongoing phase IIb, confirming safety and tolerability, as well as low deviation in pain measurements. The study is now progressing according to plan towards the goal of presenting top-line data in the fourth quarter of this year.
In July, about 90 per cent of the patients had completed their 12-month follow-up. This means that Stayble has secured most of the data, which increases the likelihood of being able to draw conclusions about the study’s results.
Phase Ib study in herniated disc initiated
During the second quarter, Stayble Therapeutics also continued with the initiation of the clinical phase Ib study in patients suffering from pain due to herniated discs in the lumbar spine. According to the report, the herniated disc study is ongoing with several initiated clinics in Poland. The company looks forward to treating the first patients in Q3. The study mainly evaluates safety and tolerability, but also volume changes of the disc.
Strategic recruitments
In addition, the company has also made significant additions to its team through strategic recruitments during the second quarter. In April, Jarkko Kalliomäki joined as Chief Medical Officer with extensive experience in rehabilitation medicine, pain management and the pharmaceutical industry. In addition, Dr. Daisuke Sakai was presented as a new scientific advisor with expertise in the treatment of degenerative disc disease and herniated discs, as well as experience from the Japanese market.
Fruitful partnership discussions
The report also highlights that progress has been made in the work on partnerships. The company’s participation at the BIO International Convention in Boston led to fruitful discussions and several promising contacts with global companies with the capacity to implement a clinical phase III program with STA363, as well as regulatory preparations and future commercialisation.
The interest in STA363 was great during the conference, according to CEO Andreas Gerward:
»During the meeting, we noted an increased interest in projects focused on long-term pain and in the outcome of our phase IIb study, where even a moderate effect on the pain scale is seen as highly interesting. The response we have received, together with the fact that our drug candidate STA363 now covers two indications, means that we look forward to further interesting discussions.«
Exciting autumn with reporting of results
The company is now looking forward to an exciting autumn with results from the phase IIb study and recruitment of the first patients in the phase Ib study. Two indications in the portfolio increases the value of the STA363 project and reduces the development risk. At the same time, the chance increases of developing a new and effective treatment that can provide lifelong relief from chronic back pain – and make a real difference in people’s daily lives.
The company’s progress during the spring, and expectations for the autumn, are also reflected in the share price, which has increased by about 105 per cent over the past three months.
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.
