JNPMEDI announced on Thursday that it will provide comprehensive support for domestic Phase 1/2a clinical trials of speroQure, an injectable cell therapy for osteoarthritis developed by BioSolution.
The clinical trial will commence following approval of the Investigational New Drug (IND) application by the Ministry of Food and Drug Safety. JNPMEDI plans to offer expert consulting and practical support to ensure the successful launch and execution of the clinical trial.
SperoQure is an allogeneic cartilage cell therapy that employs three-dimensional spheroid culture technology and cartilage differentiation stimulation techniques. Unlike traditional surgical or arthroscopic treatments, it can be administered with a single injection into the knee joint, potentially reducing patient discomfort and improving treatment accessibility.
JNPMEDI will oversee the entire clinical trial process, including trial design and preparation, project management, site operations and monitoring, data management, statistical analysis, and safety and quality control measures.
Jung Kwon-ho, Chief Executive Officer (CEO) of JNPMEDI, emphasized the significance of the speroQure trial, stating that this study not only evaluates pain relief and functional improvement but also explores potential structural changes in the joint. It will work closely with BioSolution, leveraging the expertise in clinical operations, data management, and statistical analysis to ensure a smooth trial process and generate reliable results.
JNPMEDI, known for developing artificial intelligence (AI)-based clinical trial data management platforms, provides clinical trial operation and data management services to pharmaceutical and biotech companies both in the U.S. and internationally.