Ferring Announces Positive Topline Phase 3 Results for SI-6603, an Investigational Treatment for Lumbar Disc Herniation

• The primary endpoint was met: SI-6603 showed statistically significant improvement in worst leg pain score versus control at 13 weeks after injection.

• SI-6603 was generally well-tolerated.

• Ferring’s clinical development partner, Seikagaku Corporation, plans to proceed with preparation for a Biologics License Application to the U.S. Food and Drug Administration.

Ferring Pharmaceuticals (Ferring) announced that its clinical development partner, Seikagaku Corporation (Seikagaku), achieved positive topline results for its registrational Phase 3 clinical trial of SI-6603, an investigational treatment for lumbar disc herniation (generic name: Condoliase).

The study was a randomized, double-blind, controlled, parallel-group, comparative study of SI-6603 in 352 patients with lumbar disc herniation. The primary endpoint for the trial was met. SI-6603 showed statistically significant improvement in worst leg pain score, as assessed by a 100 mm Visual Analog Scale (VAS), versus control at 13 weeks after injection. SI-6603 was generally well-tolerated.

Based on the positive study outcome, Seikagaku plans to proceed with preparation for a Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA). Ferring plans to commercialize the product in the United States and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan.

“In the United States, 2-3% of the population suffers from radicular leg pain or sciatica caused by lumbar disc herniation¹ 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 non-surgical treatment option for patients and their healthcare providers.”

About SI-6603

SI-6603, which contains Condoliase as its active pharmaceutical ingredient, is intended to treat lumbar disc herniation via a single, direct intradiscal injection. It has the potential benefit of not requiring general anesthesia and being less invasive to patients than surgical treatment.

Marketing approval for SI-6603 in Japan was obtained from the Japanese Ministry of Health, Labour and Welfare in March 2018, and SI-6603 has been marketed as HERNICORE^® 1.25 units for intradiscal injection through Seikagaku Corporation’s Japanese sales partner Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan) since August 1, 2018.²

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, uro-oncology and in specialty areas within gastroenterology, including microbiome therapeutics, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.ferringusa.com.

References:

¹Vialle LR, Vialle EN, Suárez Henao JE, Giraldo G. LUMBAR DISC HERNIATION. Rev Bras Ortop. 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. PMID: 27019834; PMCID: PMC4799068.

²Press Release. Seikagaku and Kaken Announce the Launch of HERNICORE^® 1.25 Units for Intradiscal Injection in Japan. July 31,2018. Available at: https://www.seikagaku.co.jp/en/news/news-6617037418084939174/main/0/link/20180731-e.pdf. Accessed May 24, 2023.

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