MS pill 'promising' but next trial delayed

Swiss drugmaker Novartis AG has pushed back the start of a late-stage trial of its FTY720 pill for multiple sclerosis after the Food and Drug Administration asked for a safety analysis of the drug’s use in transplant patients.

Investors and analysts have been watching the experimental drug’s progress carefully, believing it could be a potential blockbuster seller for Novartis, as well as being one contender in the race to bring the first pill for treating MS to the market.

Over 2 million people worldwide are thought to have MS, a disabling disorder of the central nervous system in which the immune system is thought to attack healthy nerve tissue.

Symptoms include slurred speech, numbness, pain, poor balance and blurred vision. Most MS patients have a relapsing form of the disease, meaning symptoms come and go, and most current treatments are injected.

Novartis said on Tuesday that Phase II data on FTY720 in MS was promising but the Phase III trial would now start in the fourth quarter of 2005, rather than mid-2005 as previously announced.

Details of the six-month, Phase II study released on Tuesday in Vienna were promising, Novartis said, showing a more than 50 percent reduction in relapses and up to an 80 percent reduction relative to placebo in terms of brain lesions seen in scans.

However, Novartis said that the U.S. regulators had asked the firm to conduct a safety analysis of data from Phase III trials of the drug’s use as a treatment to prevent organ rejection in kidney transplant patients.

Some cases of macular edema, or swelling in the eye, had been observed in the transplant trial but not in the MS trial, a Novartis spokesman said, adding that the transplant trial had used higher dosages of FTY720 than the MS trial.

“As a result, the Phase III programme in MS is expected to be launched in the fourth quarter of 2005 involving centres in North America and Europe,” Novartis said.

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Promising data
The Phase II trial, involving daily 1.25 mg or 5 mg doses of FTY720, showed the drug was well-tolerated with 92 percent of patients completing the six-month trial. The most frequent side effects included headaches, respiratory problems and diarrhoea.

“There was no real drop-out rate and a clear-cut, highly statistically significant advantage of the drug over placebo at both doses,” Ludwig Kappos, chief investigator of the trial, told Reuters.

“There was a tendency as you would expect in a drug that acts on the immune system towards a somewhat higher rate of infection especially with a higher dose but not serious infection,” he said.

Swiss biotech company Serono SA is also working on a pill to treat MS, dubbed Mylinax, while British-based GlaxoSmithKline Plc plans to file a competitor for regulatory approval in 2008.

Patients with MS were dealt a blow earlier this year when Elan Corp and Biogen Idec’s Tysabri, which had been expected to revolutionise MS treatment, was pulled after it was linked to a rare brain infection.

Serono hopes its Rebif drug, co-marketed with Pfizer in the United States, will become the number one MS treatment in time, despite competition from rivals made by Germany’s Schering AG and Biogen.