Centocor highlights “promising results” for ustekinumab

The Johnson & Johnson subsidiary Centocor has highlighted that its human monoclonal antibody ustekinumab has shown “promising efficacy and safety results” in phase III clinical trials investigating its use in chronic moderate to severe plaque psoriasis.

Following a comprehensive development programme that included two large phase III trials, Centocor has now announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics Licence Application for ustekinumab (CNTO 1275).

The decision by the FDA follows the submission of a Marketing Authorisation Application for ustekinumab to the European Medicines Agency in December 2007 and which is still currently under review.

However, one-year findings from the two phase III trials were presented for the first time this week at the annual meeting of the American Academy of Dermatology.

The trials, which involved nearly 2,000 patients, evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque psoriasis.

Both trials met the primary endpoint which was the proportion of patients who achieved at least a 75 per cent reduction in psoriasis as measured by the Psoriasis Area and Severity Index.

Last month, Catalyst Biosciences announced that it had signed a collaboration agreement with Centocor Research & Development for the discovery and development of engineered protease therapeutics.