Novartis (NVS) continues to progress well with the development of its psoriasis candidate, secukinumab (AIN457).
The company reported encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on secukinumab in Jul 2013.
Novartis is now out with positive results from the FIXTURE study. It was observed from the randomized double-blind, placebo-controlled study (n =1,306) that secukinumab showed improved efficacy to Amgen’s (AMGN) Enbrel in patients suffering from moderate-to-severe plaque psoriasis.
We note that the phase III study met both primary and key secondary endpoints. The results showed that secukinumab was more effective in clearing skin faster with a long lasting effect than Enbrel.
Novartis also presented data from an additional phase III study, SCULPTURE (StudyComparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimens vs reTreatment Upon start of RElapse), on secukinumab. The data from the study also showed efficacy of secukinumab dosed at monthly intervals.
We note that secukinumab is one of the most promising pipeline candidates at Novartis and we are encouraged by the results from the FIXTURE study. Novartis remains on track to file for approval of the candidate in the EU and the U.S. later in 2013.
We note that secukinumab is also being evaluated for other indications such as psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis among others. The phase III studies for these indications are ongoing with results expected in 2014.
Additionally, secukinumab is in phase II studies for the treatment of multiple sclerosis.
Secukinumab is the first anti IL-17A on which phase III results have been presented. We note that Amgen has an anti IL-17 candidate, brodalumab, in its pipeline. Brodalumab is currently in phase III studies for the psoriasis indication.
Meanwhile, currently approved products include AbbVie’s (ABBV) Humira among others.
Novartis currently carries a Zacks Rank #3 (Hold). Right now, Roche (RHHBY) looks well placed with a Zacks Rank #1 (Strong Buy).
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