Secukinumab to commence phase III trials
Novartis says a new drug for hard-to-treat psoriasis has shown encouraging efficacy in a phase II trial and is now scheduled to start phase III testing next year.
Secukinumab (AIN457) was three times more effective than placebo in the study in improving the symptoms of moderate-to-severe plaque psoriasis, including lesions on the hands, feet and nails, with early signs that it may improve quality-of-life scores.
"AIN457 … demonstrated significant improvement in the signs and symptoms of patients, even when difficult-to-treat areas are involved," commented study investigator and dermatologist Professor Kristian Reich.
"Many patients with hand, foot or nail psoriasis are restricted in their daily life and work because they may not be able to walk or use their hands, negatively impacting their quality of life," he added.
The primary endpoint of the phase II study was reported last year and showed that the drug was effective in up to 81 per cent of patients treated.
Novartis now has data from a subgroup analysis which focused in on the first four weeks of treatment, in which AIN457 was given by subcutaneous injection once a week.
Novartis' drug reduced moderate-to-severe plaques in 54 per cent of patients after a month, with only 19 per cent of the placebo group showing this level of improvement. In the maintenance phase of treatment the drug was given once a month, and after 12 weeks around 25 times more patients on AIN457
AIN457 is a fully human monoclonal antibody neutralising interleukin-17A that may provide a new mechanism of action for the treatment of immune-mediated diseases.
Novartis is developing the drug not only psoriasis but also uveitis and rheumatoid arthritis, although a trial in Crohn's disease reported earlier this year failed to show efficacy.
Market analysis firm Datamonitor has predicted that AIN457 will be launched for psoriasis in 2014, and as the first anti-IL17 product could achieve sales of $252m by 2020, hitting blockbuster levels at peak.
At the moment psoriasis therapy is dominated by Amgen/Pfizer's Enbrel (etanercept) with around a third of the $4.5bn overall market in 2011, although Abbott Laboratories' Humira (adalimumab) is closing on the leader and recent entrant Stelara (ustekinumab) from Janssen Biotech has made strong gains since its launch in 2009.