Date: 2014-12-01
Type of information: Results
phase:
Announcement:
Company: Novartis (Switzerland)
Product: fingolimod
Action
mechanism: Gilenya® (fingolimod), licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In multiple sclerosis, the immune system damages the covering that protects nerve fibers in the central nervous system which includes the brain and spinal cord. Fingolimod reduces the ability of T cells to move from the lymph nodes towards the brain and spinal cord thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor on the T cells called the sphingosine-1-phosphate receptor, which is involved in regulating the movement of these cells in the body. Gilenya® is approved in the US for first-line treatment of relapsing forms of MS in adults. In the EU, Gilenya® is indicated for adult patients with highly active relapsing-remitting MS (RRMS) defined as either high disease activity despite treatment with at least one disease-modifying therapy (DMT), or rapidly evolving severe RRMS.
Disease: primary progressive multiple sclerosis (PPMS)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey, UK, USA
Trial
details: The INFORMS study is a double-blind, randomized, multi-center, placebo-controlled parallel group study, comparing the efficacy and safety of fingolimod (0.5 mg) versus placebo in people with primary progressive multiple sclerosis (PPMS)[16]. The INFORMS study is the largest clinical trial ever conducted in PPMS. Nine-hundred and seventy (970) people aged 25-69 years with PPMS were enrolled in INFORMS from 148 sites, across 18 countries, including Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey, UK and the US. Patients were treated for at least three years. The primary endpoint was to evaluate the effect of fingolimod versus placebo on reducing the risk of three-month sustained disability progression based on a composite measure of Expanded Disability Status Scale (EDSS), assessment of upper limb function (9-Hole Peg Test, HPT), and walking speed (25-foot Timed Walk Test, TWT).
Latest
news: * On December1, 2014, Novartis announced that the Phase III INFORMS study in primary progressive multiple sclerosis (PPMS) did not show a significant difference between fingolimod and placebo on a combination of disability measures. The safety results were consistent with the well-characterized safety profile of fingolimod in relapsing MS (RMS). The INFORMS study was based on the knowledge that fingolimod enters the central nervous system (CNS) and can interact with damage-causing cells residing in the CNS. It was hypothesized that this central effect, which is well understood in relapsing forms of MS, would also be relevant in PPMS. As opposed to the consistently strong efficacy seen in relapsing MS, the results of the INFORMS study seem to suggest that PPMS and relapsing forms of MS have different underlying mechanisms.
