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

2023-05-26

临床结果临床3期上市批准

PARSIPPANY, N.J.--(BUSINESS WIRE)--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).

'In the United States, 2-3% of the population suffers from radicular leg pain or sciatica caused by lumbar disc herniation<sup>1 </sup>and current pharmacological treatment options are inadequate'

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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