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Stayble Therapeutics, a Swedish life science company, and OCT Clinical are delighted to report that the last patient has been enrolled in the ongoing phase IIb clinical trial of STA363. The study aims to prove efficacy and safety of the treatment in patients suffering from chronic discogenic low back pain. As the principal CRO for this study, OCT Clinical are overseeing 110 adult patients at 14 clinical sites across Europe.
This is a multicenter, randomized phase IIb study, the primary goal of which is to evaluate the efficacy of the study medicine versus placebo. The study is double-blinded, which means that neither the patient nor the treating physician knows whether the patient is receiving a high or low dose of STA363, or a placebo. The patients will be followed up for 12 months. Final results from the study are expected to be available in the fourth quarter of 2023.
'Recruiting during the toughest months of the pandemic, was a big challenge for everyone involved in this study. However, our legal and local expertise enabled us to deliver the best possible service and achieve target number of patients. Needless to say, communication with the Sponsor was very effective and smooth, which also contributed to reaching this milestone.' - Irina Petrova, Head of Clinical Operations, OCT Clinical.
Andreas Gerward, CEO at Stayble Therapeutics, commented: 'We have reached another significant milestone. The study has been going on during challenging times to say the least, and I am therefore particularly proud of our recruitment efforts, which reflect a strong effort from our whole team, including our principal CRO, OCT Clinical. Without their resilience, energy, amazing control, efficiency and cooperative approach we wouldn’t have got here so soon.'
Within this project, the OCT Clinical team is responsible for a wide scope of clinical trial services: project management, site management, data management, biostatistics, medical writing, medical monitoring, clinical monitoring, logistics, pharmacovigilance, quality assurance, and regulatory support.
About Stayble Therapeutics
Stayble Therapeutics is a Swedish life science company developing an injectable treatment against chronic low back pain triggered by disc degeneration. Stayble Therapeutics initiated a multinational clinical phase 2b trial in2020.For more information, please, visit https://staybletherapeutics.com/.
About OCT Clinical
OCT Clinical is one of the leading CROs, with clinical operations in Central and Eastern Europe and the CIS region. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. The CRO delivers both standalone services such as medical writing, consultancy, project management, monitoring, data management, biostatistics and turnkey service for clinical development. Learn more at www.OCT-ClinicalTrials.com
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.
