SEIKAGAKU CORPORATION

Seikagaku Launches Phase III Trials for Single-Injection Osteoarthritis Treatment in Japan

3 months ago

• Seikagaku Corporation has initiated three Phase III clinical studies in Japan for Gel-One®, evaluating its efficacy in both knee and hip osteoarthritis patients. • The treatment utilizes a unique cross-linked hyaluronate hydrogel technology, designed to provide long-term pain relief through a single intra-articular injection. • Already available in the US, Taiwan, and Italy for knee osteoarthritis since 2012, the Japanese trials aim to expand treatment options to include hip osteoarthritis.

FDA Panel Supports Condoliase Injection for Herniated Disc-Related Leg Pain

4 months ago

• FDA advisory panel voted 8-4 in favor of condoliase for radicular leg pain due to lumbar disc herniation, highlighting its potential for patients who have not responded to conservative treatments. • The panel emphasized the need for a narrow indication, focusing on patients with confirmed nerve root impingement and failure of at least 6 weeks of conservative therapy. • Concerns were raised regarding potential immune-related adverse events and long-term effects on spinal health, necessitating careful monitoring and further research. • Condoliase, currently available in Japan, works by reducing disc volume and relieving pressure on the nerve root, offering a non-opioid alternative to surgery for some patients.

Condoliase (SI-6603) Shows Promise in Phase 3 Trials for Lumbar Disc Herniation

8 months ago

• SI-6603, an investigational treatment, significantly improved leg pain compared to sham in U.S. and placebo in Japan at Week 13 in Phase 3 trials. • The studies involved intradiscal injections of SI-6603 and demonstrated statistically significant changes from baseline in worst leg pain. • Common adverse events included spinal MRI abnormalities and back pain, with no treatment-related serious adverse events reported in the U.S. study. • These findings support SI-6603's potential as a therapeutic option for radicular leg pain associated with lumbar disc herniation.