Novartis AG Fingolimod Ph3 Trial In PPMS Fails To Meet Primary Goal
Published: Dec 03, 2014
December 1, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Novartis , the Switzerland-based biopharmaceutical company, announced today that its Phase III trial for fingolimod did not meet its primary endpoint. The drug, which is marketed as Gilenya, is designed to treat relapsing forms of multiple sclerosis, specifically Primary Progressive Multiple Sclerosis. However, no significant differences between fingolimod and the placebo were noted during the trial.
"We understand this news is very disappointing for those affected by PPMS and involved in its management,” said Vasant Narasimhan, global head of development at Novartis Pharmaceuticals. “While PPMS is a focus of the MS community, relatively little is known about the disease so finding effective treatments remains a challenge. We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease. Gilenya revolutionized the treatment of relapsing MS as the first oral disease-modifying therapy. We remain strongly committed to continuing to research new treatment options for patients with MS and other neurological conditions."
PPMS impacts more than 2.3 million patients who are living with MS around the world. The disease impacts the central nervous system and causes irreversible damage. Currently, there is no approved treatments for PPMS that have been shown to change the course of the disease in patients. Drugs on the market are specifically aimed toward treating symptoms of PPMS, rather than the disease itself.
The Phase III study, also known as INFORMS, was a double-blind, randomized, multi-center, placebo-controlled parallel group study. The goal was to determine the efficacy and safety of fingolimod versus the placebo in patients living with PPMS. To date, INFORMS is the largest clinical trial ever conducted in PPMS. A total of 970 people were enrolled in the study from countries including Denmark, Finland, Australia and the U.K.
Fingolimod is designed to target both focal and diffuse central nervous system damage that occurs in patients who have relapsing forms of MS. It works by preventing the cells that cause focal inflammation from reaching the brain. Additionally, it enters the central nervous system to prevent the activation of harmful cells. Novartis’ portfolio for MS includes fingolimod and Extavia, also known as an interferon beta-1b for subcutaneous injection.