April 18, 2007
A compound under heavy patent protection that could provide future relief for rheumatoid arthritis patients is moving into a Phase 2 study to evaluate safety and efficacy.
An immunomodulator developed by Merrimack Pharmaceuticals, Inc, (www.merrimackpharma.com) MM-093, is a recombinant version of human alpha-fetoprotein (AFP) that has not yet received approval from the FDA or any other international regulatory agency. The compound is also in clinical development as a treatment agent for patients who suffer from psoriasis or autoimmune uveitis
The study is being conducted at 15 locations throughout the United States and administered to approximately 100 patients who suffer 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 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.
"MM-093 has been well-tolerated in studies to date and we believe its unique profile will differentiate it from other therapies and allow it to make a significant difference in the highly competitive RA market," said Robert Mulroy, President & CEO of Merrimack. "Despite the advances that have been made in treating the signs and symptoms of RA, there remains a significant need for safer, more effective therapies."
MM-093 has also completed both a Phase 1 study in healthy volunteers and a pilot study in RA patients that demonstrated it was well tolerated and bioactive in addressing the signs and symptoms of RA.
Merrimack controls 14 issued patents for MM-093 and a number of pending applications, both in the U.S. and internationally, that cover composition of matter, production methods and therapeutic uses of the drug.