Novartis compound beats Enbrel
pharmafile | July 9, 2013 | News story | Sales and Marketing | Enbrel, Novartis, Pfizer, skin
One of Novartis’ investigational drugs has beaten Pfizer’s Enbrel in a head-to-head Phase III psoriasis study and is on course for regulatory submission in the second half of the year.
The manufacturer says top-line results from the FIXTURE trial of more than 1,300 moderate-to-severe plaque psoriasis patients, suggested subcutaneous secukinumab (AIN457) demonstrated superiority to anti-tumour necrosis factor (TNF) therapy Enbrel (etanercept) – a current standard of care – when it came to clearing skin.
Novartis’ excitement really stems from the fact that the drug is the first with this mechanism to present Phase III results – and although full results of the trial will not be published till later in 2013, the company believes it could provide a new mechanism of action to treat immune-mediated diseases.
Secukinumab selectively binds to IL-17A, a pro-inflammatory cytokine – which is important in driving the body’s autoimmune response and is found in high concentration in skin affected by psoriasis – and neutralises its effect.
Secukinumab met all primary and secondary endpoints in the trial, which was designed to demonstrate efficacy after 12 weeks of treatment – compared to placebo and Enbrel – and to assess safety, tolerability and long-term effectiveness up to 52 weeks.
“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,” suggested Tim Wright, global head of development, Novartis Pharmaceuticals.
Measures of success in clearing skin included PASI 75 (Psoriasis Area and Severity Index 75) and the Investigator’s Global Assessment (IGA mod 2011), a standard tool.
Novartis hopes that it will have other applications: data for secukinumab in arthritic conditions – psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis – will start to be revealed in 2014 and the company says Phase II studies are ongoing in multiple sclerosis.
Adam Hill
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