Positive topline results were announced from a registrational phase 3 trial evaluating the efficacy and safety of SI-6603 (condoliase), an investigational treatment for lumbar disc herniation.
SI-6603 contains condoliase, a mucopolysaccharidase-degrading enzyme extracted from the bacterium, Proteus vulgaris. The enzyme degrades glycosaminoglycans in the nucleus pulposus of the vertebral disc. According to Ferring, SI-6603 has the potential for being a less invasive treatment option for lumbar disc herniation than surgery. It is administered as a single, direct intradiscal injection.
The multicenter, randomized, double-blind, sham-controlled, comparative study (ClinicalTrials.gov Identifier: NCT03607838) included 352 adult patients 30 to 70 years of age with confirmed lumbar disc herniation. Patients were randomly assigned to receive placebo or SI-6603. Findings showed that treatment with SI-6603 met the primary endpoint, demonstrating a statistically significant improvement in worst leg pain score, as assessed by a 100mm Visual Analog Scale (VAS), at 13 weeks compared with placebo. The treatment was reported to be well tolerated.
“In the United States, 2-3% of the population suffers from radicular leg pain or sciatica caused by lumbar disc herniation and current pharmacological treatment options are inadequate,” said Elizabeth Garner, MD, MPH, Chief Scientific Officer, Ferring USA. “The positive topline results offer the hope of a nonsurgical treatment option for patients and their health care providers.”
Based on these findings, the Company’s clinical development partner, Seikagaku Corporation, plans to submit a Biologics License Application to the Food and Drug Administration.
- Ferring announces positive topline phase 3 results for SI-6603, an investigational treatment for lumbar disc herniation. News release. Ferring. Accessed May 26, 2023. https://www.businesswire.com/news/home/20230526005030/en/Ferring-Announces-Positive-Topline-Phase-3-Results-for-SI-6603-an-Investigational-Treatment-for-Lumbar-Disc-Herniation.