BioSolution, led by CEO Lee Jeong-seon, is moving into clinical trials for an injection-based osteoarthritis treatment.
The Ministry of Food and Drug Safety has approved an investigational new drug application for speroQure, the company said Tuesday.
speroQure is a multi-mechanism cell therapy developed through three-dimensional spheroid culture and cartilage-differentiation stimulation, giving cells anti-inflammatory and anti-catabolic properties. The therapy is further designed to promote cartilage regeneration by inhibiting angiogenesis and enhancing anabolic activity. The spheroid structure allows cells to survive longer within the joint and continuously secrete therapeutic substances, the company said.
Unlike conventional autologous or allogeneic cartilage transplants and cell implantation procedures, speroQure requires no arthroscopy or incision. A single intra-articular injection into the knee joint is expected to reduce the surgical burden and improve procedural convenience.
The combined Phase 1/2a trial will enroll patients with Kellgren-Lawrence (K&L) grade 2 or 3 knee osteoarthritis. The Phase 1 portion will assess dose-level safety and tolerability in up to 18 subjects to determine the dose for Phase 2a. The Phase 2a portion will be conducted as a multicenter, placebo-controlled, randomized, double-blind study, with plans to recruit either 41 or 68 participants depending on the maximum tolerated dose established in Phase 1.
The two primary efficacy endpoints are changes in the 100mm visual analog scale pain score and the WOMAC functional score at 24 weeks post-administration. Secondary and exploratory endpoints will cover joint-structure-related indicators including pain and function, quality of life, MRI and radiographic imaging, and biomarkers.
"Our goal is to evaluate safety and improvements in pain and function through the trial, and to confirm the potential for joint-structure improvement as well," Lee said. "We will also explore overseas clinical trials and business development for entry into the global market."
freiheit@heraldcorp.com
