Ferring's Promising Study Results for Lumbar Disc Herniation
Ferring Pharmaceuticals Presents New Data on SI-6603
PARSIPPANY, N.J.—Ferring Pharmaceuticals, alongside its collaborator Seikagaku Corporation, recently unveiled promising findings from two Phase 3 studies concerning the innovative treatment SI-6603 (condoliase). This investigational drug is being evaluated for its effectiveness in alleviating radicular leg pain associated with lumbar disc herniation (LDH). The presentations made at the North American Spine Society’s Annual Meeting showcased striking results from one study in the U.S. and another in Japan. Additionally, the pivotal U.S. Phase 3 trial findings have been published in The Spine Journal.
Insight from the NASS Presentation
Both studies were designed as double-blind, placebo-controlled trials where LDH patients received either a single injection of SI-6603 or a control substance—a sham for the U.S. study and a placebo for Japan. After a 52-week observation period, significant improvements were recorded. For instance, the U.S. study noted a least squares mean (LSM) difference of -7.5 with a p-value of 0.0263, while the Japan study observed an LSM difference of -15.2 with a p-value of 0.001.
Clinical Implications of Study Results
Dr. Kee Kim from the University of California, Davis, emphasized the significance of these findings, stating, "Currently, treatment options for radicular leg pain due to lumbar disc herniation primarily involve conservative management, which can limit efficacy. The data from these Phase 3 studies strongly supports SI-6603 as a viable therapy for those impacted by this challenging condition. This could change countless lives for the better."
Safety and Adverse Events Observed
The U.S. trial showed notable treatment-emergent adverse events (TEAEs), with spinal MRI abnormalities reported at 28.1% for those receiving SI-6603 compared to only 9.2% in the sham group. Back pain was another common issue, affecting approximately 19.2% of participants on SI-6603 versus 12.6% on the placebo. In comparison, the Japanese trial recorded back pain as the most common TEAE, with occurrences at 36.6% for SI-6603 and 33.3% for the placebo.
Evaluating Treatment-Related Adverse Events
Significantly, the U.S. study reported no serious adverse events directly linked to SI-6603, whereas the Japan study noted one serious adverse event related to back pain.
Details of the U.S. Phase 3 Trial
The U.S. based trial, named the Discovery 6603 clinical trial (NCT03607838), involved a randomized structure where participants were split evenly between a SI-6603 injection and a sham, followed by a 52-week observing phase. The primary measure focused on the change from baseline (CFB) in worst leg pain during the previous 24 hours, qualified through the Visual Analogue Scale (VAS). Secondary measures covered additional pain assessments and quality of life indicators. Notably, while results were encouraging at Week 13, key secondary measures did not reach significance, showcasing the complexities of evaluating treatment effects over time.
Overview of the Japanese Phase 3 Trial
Similar in structure, the Japanese trial included a double-blind, placebo-controlled format. Participants also received either a dose of SI-6603 (1.25 U) or a placebo, followed by a year of observation. The main endpoint focused on CFB to Week 13 using the VAS for leg pain assessment, further investigating changes leading up to Week 52.
Understanding Lumbar Disc Herniation
Approximately nine million adults in the U.S. are affected by lumbar disc herniation annually. This condition results primarily from the displacement of the inner component of the intervertebral disc, leading to nerve compression and subsequent pain. Such occurrences can hinder everyday tasks and significantly impact quality of life.
About the Investigational Product SI-6603
SI-6603, formulated with condoliase, aims to address radicular leg pain through a single direct injection. This product acts by alleviating nerve root compression, which is critical for pain relief in affected individuals.
Commercial Development of SI-6603
Seikagaku developed SI-6603, achieving marketing approval in Japan in early 2018. Since then, it has been marketed as HERNICORE 1.25 units for intradiscal injection, primarily through Kaken Pharmaceutical Co., Ltd.
Collaboration with Seikagaku
Ferring established a licensing agreement with Seikagaku regarding SI-6603 in 2016, aiming to commercialize the treatment in the U.S. following FDA review. The agreement extends Ferring's development and commercialization rights globally, except in Japan.
Ferring Pharmaceuticals — Who We Are
Founded in 1950 and headquartered in Switzerland, Ferring Pharmaceuticals is a global leader dedicated to improving patient care. The company operates in various medical fields, including reproductive medicine, gastroenterology, and orthopaedics. Ferring employs over 7,000 people internationally, with a significant number in the U.S., working to deliver innovative treatments aimed at enhancing lives.
Frequently Asked Questions
What is SI-6603?
SI-6603 is an investigational treatment developed to address radicular leg pain caused by lumbar disc herniation through a single intradiscal injection.
How effective was SI-6603 in the studies?
The studies revealed significant pain relief, with notable improvements over baseline measurements compared to controls.
What types of adverse effects were observed in the trials?
Participants experienced some treatment-emergent adverse events, with back pain and MRI abnormalities being the most common.
What is lumbar disc herniation?
Lumbar disc herniation occurs when the gel-like center of a spinal disc displaces through its outer layer, potentially compressing nerves and causing pain.
Is SI-6603 approved for use in the United States?
SI-6603 is currently under review with the FDA and has not yet been approved for use in the United States.
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