Results of extended phase 2 trial support Norvartis' FTY720 as a treatment for MS

By Lisa Kerner

Erie, Pa., April 6 - Novartis said data from its extended phase 2 study support the effects of FTY720 (fingolimod), a novel once-daily oral compound in development for treatment of relapsing-remitting multiple sclerosis (MS), a common inflammatory and neurodegenerative disorder of the central nervous system.

The data, presented at the American Association of Neurology meeting, showed that both patient groups taking FTY720 (1.25 mg and 5 mg) who had experienced more than a 50% reduction in their annualized relapse2 rate during the study's first six months compared to a placebo maintained this low relapse rate during the subsequent 12-month extension.

Current MS therapies offer an average reduction in relapse rates of only 30% in two-year studies and require frequent injections, according to a company news release.

In the placebo-controlled phase 2 study, conducted at 32 centers in 11 countries, 281 patients were randomized in equal numbers to receive either a placebo, 1.25 mg of FTY720 or 5 mg of FTY720 orally once-daily for six months.

Results were measured by Magnetic Resonance Imaging and clinical relapses, as well as its tolerability and safety.

Novartis said the 5 mg dose arm was discontinued after 12 months and patients previously receiving 5 mg continued in the study on the 1.25 mg dose.

The most frequently reported adverse events in patients treated up to 18 months were non-serious infections, such as colds and influenza, and headache.

"We are very encouraged to see that the effects of fingolimod in significantly reducing both clinical relapses and inflammatory disease activity are maintained over 18 months," Paul O'Connor of St. Michael's Institute in Toronto said in the release.

"We hope that the magnitude of benefits shown in the phase 2 study can be confirmed in the larger-scale phase 3 study program, which is currently being initiated."

Novartis started enrolling patients in its first phase 3 pivotal study, Fingolimod Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis (Freedoms). The 24-month, randomized, double-blind, placebo-controlled study will include more than 1,000 patients with relapsing-remitting MS between age 18-55.

Novartis is a Basel, Switzerland-based pharmaceutical company.

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