Sanofi eyes phase III move for sarilumab in rheumatoid arthritis
pharmafile | July 13, 2011 | News story | Research and Development | Regeneron, Sanofi, ankylosing spondylitis, research and development news, rheumatoid arthritis, sarilumab
Sanofi is poised to move sarilumab into phase III trials for rheumatoid arthritis after the monoclonal antibody showed positive results in a mid-stage study.
But the company and its development partner Regeneron have no such plans for sarilumab in another autoimmune disease after it disappointed in a separate ankylosing spondylitis trial.
In the phase IIb MOBILITY trial rheumatoid arthritis patients treated with sarilumab and standard RA treatment methotrexate (MTX), saw a significant improvement in signs and symptoms compared to MTX alone.
“Following these encouraging phase IIb results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the phase III portion of the MOBILITY trial,” said Elias Zerhouni, president, global research & development, Sanofi.
The MOBILITY study involved 306-patients in the dose-ranging, multinational, randomised, multi-arm, double-blind, placebo-controlled study, that compared five different dose regimens of sarilumab in combination with MTX to placebo plus MTX.
The primary endpoint of the study was the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20) after 12 weeks, but the companies have yet to release full results, including how many patients achieved the study’s primary endpoint.
George Yancopoulos, chief scientific officer and president of Regeneron Research Laboratories, did say: “The MOBILITY results provide evidence that IL-6R blockade with sarilumab represents a promising new anti-inflammatory investigational therapy for reducing RA disease symptoms.”
Sarilumab works by blocking the binding of IL-6 to its receptor and interrupting the resultant cytokine-mediated inflammatory signalling cascade.
A second trial (ALIGN) looked at patients with ankylosing spondylitis, arthritis that specifically affects joints in the spine, but this did not demonstrate any significant improvements.
Should it reach the market it would sit within a crowded marketplace led by Abbott’s biggest selling drug Humira, Pfizer’s Enbrel and Merck and J&J’s Remicade.
Sanofi and Regeneron said full data from both phase IIb trials would be submitted for presentation at an upcoming scientific conference.
Brett Wells
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