Johnson & Johnson has presented exciting data from a late-stage study of a new compound which appears to significantly reduce the symptoms of psoriasis.
J&J's Centocor unit has presented data from a 1,200-patient Phase III trial at the World Congress on Dermatology meeting in Buenos Aires, Argentina of CNTO 1275 (ustekinumab) which shows that two-thirds of people with moderate to severe plaque psoriasis receiving two doses of the drug achieved at least a 75% reduction in the skin disease at week 12, as measured by the Psoriasis Area and Severity Index (PASI 75). Ustekinumab, a new, fully-human monoclonal antibody, targets interleukin 12 and 23, naturally-occurring proteins that are important in normalising the immune system and are also believed to play a role in immune-mediated inflammatory diseases.
Also, following one additional dose at week 16, a substantial proportion of patients receiving ustekinumab maintained a PASI 75 response through week 28. Other data presented at the meeting show that as early as week four patients treated with either 45mg or 90mg ustekinumab, experienced significant improvements in quality of life measures compared with those on placebo.
Craig Leonardi, of the St Louis University Medical School and lead investigator of the study, said that the findings provide further evidence of the role of IL-12/23 in the pathogenesis of psoriasis “and the promise that a new therapeutic approach like ustekinumab may hold for dermatologists and their patients living with this chronic, immune-related disease." He added that the efficacy and safety data for CNTO 1275 “are exciting for the dermatology community."
The excitement around the new drug centres around the view that it has the same efficacy as anti-tumour necrosis factor therapies such as J&J’s existing blockbuster Remicade (infliximab) and Amgen’s Enbrel (etanercept). but without the side effects associated with the latter drugs, such as infections. Also, ustekinumab is self-injectable and can be given less frequently than Enbrel, while Remicade requires a two-hour intravenous infusion at a doctor's.
Abbott has a rival drug but further back
Centocor plans to file a New Drug Application in the USA by the end of the year. Abbott Laboratories also has a drug, ABT-874, that targets the same proteins as CNTO-1275 but that compound is some way behind the J&J drug in terms of development. At the Buenos Aires conference, Abbott presented Phase II data which showed that psoriasis patients who took ABT-874 were still responding to it after they discontinued treatment.
The extension study followed patients who achieved a 75% improvement in symptoms after taking the drug for 12 weeks and two-thirds of those patients maintained at least a 50% improvement at 24 weeks, or 12 weeks after discontinuing treatment. Abbott plans to begin Phase III studies with ABT-874 later this year.