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Glenmark starts Revamilast Phase IIb trials

Indian drug maker Glenmark Pharmaceuticals has started Phase IIb trials to evaluate Revamilast (GRC 4039) as a treatment for inflammatory disorders like rheumatoid arthritis (RA) and asthma.

The trials aim to determine the safety and efficacy profile of the drug in inflammatory disorders.

Glenmark has also initiated another global Phase IIb trial with Revamilast in patients with RA to establish the efficacy of three doses of Revamilast as compared to placebo to treat patients with active RA who demonstrated an inadequate response to methotrexate.

The results from Phase I studies showed that the healthy human volunteers treated with Revamilast demonstrated a good ex-vivo inhibition of the inflammatory marker TNF-a with maximum inhibition upto 93%.

The pharma firm is planning to start the Phase III trials for at least one indication in the second half of FY 2012-13.

Glenmark president and CMO Steffen Stuerzebecher said the clinical trials and the animal studies data for Revamilast are promising for both indications – asthma and RA.