Positive results from a late-stage clinical trial of ozanimod could make way for another effective multiple sclerosis (MS) treatment.
In the Celegen clinical trial, dubbed “Sunbeam”, two doses of ozanimod demonstrated statistically significant superiority over Biogen’s Avonex in reducing the annual relapse rate for patients with relapsing remitting MS (RRMS).
Ozanimod also bested Avonex by reducing the number of new brain lesions seen in MS patients.
Celegen is conducting a second phase III study of ozanimid in MS patients, with results expected in the second quarter.
While most MS drugs have to be injected Ozanimod is dosed as a convenient pill. Ozanimod belongs to the same S1P modulating class of drugs as Novartis' Gilenya.
Gilenya has tolerability issues, most notably a slowing heart rate which forces doctors to monitor patients after the first dose is taken. Ozanimod appears to sidestep heart-related tolerability issues, although additional data will be needed to confirm.
Celgene said the safety and tolerability of ozanimod in the phase III Sunbeam study was "consistent" with results from previously reported phase II studies. No further details were provided.
Multiple sclerosis has become an increasingly crowded and competitive market for drug companies and might be particularly vulnerable to pricing pressures. Celgene is developing ozanimod in other indications, including ulcerative colitis and inflammatory bowel disease. Celgene has not yet shared how it plans to move forward with ozanimod if the drug is approved, although the company has said it might build its own multiple sclerosis commercial team or seek out a partner.
Source: MS-UK (02/03/17)