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Company Pulls Plug on Investigational RA Drug
CRP-targeting agent is no better than placebo (August 5)
In a new phase II study, patients with rheumatoid arthritis (RA) and chronically elevated C-reactive protein (CRP) levels achieved dose-dependent mean reductions of up to 67% in CRP after treatment with an experimental RA drug, ISIS-CRPRx. However, even though these patients showed improvements in the signs and symptoms of the disease, the improvements were not statistically significant compared with those observed in patients given placebo.
According to the drug’s developer (Isis Pharmaceutcials), the study results do not justify further development of ISIS-CRPRx for the treatment of RA.
The drug was developed using so-called “antisense” technology, which helps a compound bind to a specific gene in order to interrupt the production of disease-causing proteins.
In January, Isis Pharmaceuticals received FDA approval for Kynamro (mipomersen sodium), which uses the same technology to treat patients with homozygous familial hypercholesterolemia, a rare genetic disorder causing dangerously high levels of “bad” low-density lipoprotein (LDL) cholesterol.
A phase II study is currently evaluating ISIS-CRPRx in patients with atrial fibrillation, with data expected in the first half of 2014.