USA-based Merrimack Pharmaceuticals has initiated a Phase II study to evaluate the safety and efficacy of its immunomodulator, MM-093, in patients suffering from rheumatoid arthritis. The compound, the firm's lead product, is a recombinant version of human alpha-fetoprotein.
The randomized, double-blind, placebo-controlled study is being conducted at 15 centers throughout the USA. The objective is to examine the safety and efficacy of MM-093 in around 90-100 patients with moderate-to-severe, active RA despite stable doses of methotrexate. Each patient will receive 60mg of MM-093 per week or placebo for 12 weeks and will then be followed for an additional four weeks. In addition to evaluating the safety of MM-093, patients will be assessed for changes in the signs and symptoms of their disease using standard clinical outcome measurements for RA, such as ACR20 and DAS28 scores.
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