Swiss drug maker Novartis AG (NVS) Monday announced that a Phase III study of psoriasis drug secukinumab or AIN457 showed that it is superior to Enbrel or etanercept and that it met all primary and secondary endpoints.
The healthcare products major noted that in a head-to-head Phase III psoriasis study, secukinumab was superior to Enbrel in clearing skin. Enbrel is an anti-tumor necrosis factor or anti-TNF therapy.
According to Novartis, Fixture, a pivotal trial for registration, was a randomized, double-blind, double-dummy, placebo controlled, multicenter global study of subcutaneous secukinumab in moderate-to-severe plaque psoriasis involving 1,307 patients.
Fixture trial is the full year investigative eXamination of secukinumab against eTanercept using 2 dosing regimens to determine efficacy in psoriasis. The study was to establish treatment measures and assess the efficacy of secukinumab, including Psoriasis Area and Severity Index 75, or PASI 75 and the Investigator's Global Assessment, a standard tool to assess the clearing of skin after treatment.
The firm noted that in the Fixture study, the observed safety profile of secukinumab was consistent with previously reported results from Phase II studies in moderate-to-severe plaque psoriasis and no new safety concerns were identified.
Tim Wright, Global Head of Development, Novartis Pharmaceuticals stated, "With 40-50% of people living with moderate-to-severe plaque psoriasis dissatisfied with their current therapies, there is clearly an unmet medical need for new therapies that act faster and longer to relieve pain, itching and other symptoms."
The company said regulatory submissions for secukinumab, a therapy targeting IL-17A, are on track for the second half of 2013. Secukinumab is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine.
The full results from the secukinumab Phase III study are likely to be presented at major medical congresses later this year.
Separately, Novartis said it has signed a development and licensing agreement with Biological E Ltd. or BioE, an Indian biopharmaceutical company, for two vaccines to protect against typhoid and paratyphoid fevers.
As part of the the license, the Novartis Vaccines Institute for Global Health or NVGH would transfer technology to BioE, which would have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world.
NVS closed Friday's regular trading at $70.72 on the NYSE.
by RTT Staff Writer
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