Belgium’s UCB has presented fresh data from a late-stage trial of its new rheumatoid arthritis compound Cimzia, in combination with methotrexate, which shows that the drug prevents structural damage to the joints.
The Phase III study, called Rapid 1, involved nearly 1,000 patients on Cimzia (certolizumab pegol), and radiographic data from the trial showed that the drug achieved its co-primary endpoint, namely statistically significant inhibition of the progression of structural damage compared with placebo. The study also showed that in both active treatment arms Cimzia improved the signs and symptoms of rheumatoid arthritis to a clinically-statistically significantly greater degree than the placebo arm in patients who had inadequately responded to methotrexate alone.
Similar results were observed with a second Phase III study (Rapid 2) of Cimzia’s subcutaneous liquid formulation and UCB added that both the Rapid trials demonstrated that effective results in the treatment of rheumatoid arthritis can be achieved with a 400mg total monthly dose of the drug. The safety and tolerability profile of Cimzia in both studies was consistent with that expected of an anti- tumour necrosis factor agent.
Further data from Phase III studies will be presented at international rheumatology congresses later this year and preparation for a licence submission in the treatment of rheumatoid arthritis is ongoing, with a filing planned in the second half of 2007.
Cimzia is under regulatory review for Crohn’s disease in the USA and Europe and Phase II data presented last summer showed that the therapy is effective in the treatment of moderate-to-severe psoriasis. UCB has high hopes for the drug and is looking to get it approved in a number of indications before one of its key growth drivers, the antiepileptic Keppra (levetiracetam) starts to lose patent protection in 2009. The company is already facing patent expiry in the USA for hayfever drug Zyrtec (cetirizine), its top seller, in December this year.