Ferring Shares Early Phase 3 Trial Results for SI-6603 in Lumbar Disc Herniation at ASPN 2024

PARSIPPANY, NJ. USA | July 15, 2024 | Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation, have announced the results of a Phase 3 data analysis on SI-6603 (condoliase), an investigational treatment for radicular leg pain caused by lumbar disc herniation (LDH). The findings were presented at the American Society of Pain and Neuroscience (ASPN) Annual Meeting and included both early treatment response evaluations and an analysis of healthcare resource utilization for LDH surgery.

The Phase 3 study was double-blind and sham-controlled, involving 341 patients who were randomized to receive either a single intradiscal injection of SI-6603 or a sham injection, followed by 52 weeks of observation. The modified intention-to-treat (mITT) population included 169 patients receiving SI-6603 and 172 receiving the sham injection. The primary endpoint of the study was the change in worst leg pain at Week 13, which showed significant improvement in the SI-6603 group compared to the sham group. Notable differences were observed as early as Week 4 and continued through Week 6.

From Week 1, a higher number of participants in the SI-6603 group showed a negative straight leg raise test, a trend that was sustained through Week 52. The study also highlighted significant differences in the percentage of participants achieving a 50% improvement in worst leg pain at various checkpoints. Importantly, there were no treatment-related serious adverse events reported with SI-6603.

Raza Ahmed, MD, Senior Director, Medical Affairs, Specialty/Orthopaedics at Ferring USA, commented on the promising early treatment response for patients suffering from debilitating radicular leg pain due to lumbar disc herniation. He expressed optimism that SI-6603 could potentially fill a treatment gap between conservative pain management and surgery, addressing an area of significant unmet patient need.

In addition to the clinical efficacy of SI-6603, an analysis of healthcare resource utilization for LDH surgery was also presented. This analysis covered over one million patients from a medical claims database, of which 58,328 underwent surgery within a year of initial diagnosis. The study found that patients who had surgery experienced more outpatient visits and a higher rate of hospitalizations compared to those who did not undergo surgery. Furthermore, nearly half of the surgery-treated patients received at least one epidural steroid injection within the first year, with many receiving multiple injections. The total healthcare costs for surgery-treated patients were substantially higher than those for non-surgery-treated patients, averaging $35,018 versus $4,384, respectively. The cost of LDH surgery itself averaged $25,993 per procedure, with inpatient surgeries being three times more expensive than outpatient ones.

The Phase 3 trial, named Discovery 6603, involved U.S. participants aged 30 to 70 with unilateral radicular leg pain due to contained posterolateral LDH. Despite conservative treatment for over six weeks, these participants required further intervention. Among the 352 randomized participants, 341 were included in the mITT population for final analysis.

SI-6603, developed by Seikagaku, is a single, direct intradiscal injection that reduces nerve root compression and pain. It has been available in Japan since 2018 under the brand name HERNICORE, following approval by the Japanese Ministry of Health, Labour and Welfare. Ferring Pharmaceuticals has plans to commercialize SI-6603 in the United States and has obtained rights for its development and commercialization worldwide, excluding Japan.

Ferring Pharmaceuticals is a biopharmaceutical group focused on reproductive medicine, maternal health, gastroenterology, and orthopaedics. Founded in 1950 and headquartered in Saint-Prex, Switzerland, Ferring operates in over 100 countries and employs more than 7,000 people worldwide. The U.S. headquarters is based in Parsippany, New Jersey.