December 12, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Shares of drugmaker Novartis were up in Friday trading on the news that its new psoriasis drug has demonstrated superiority to competing drug Stelara in a Phase III trial.
The company said today that Cosentyx (secukinumab) met the primary endpoint of achieving PASI 90, which represents clear or almost clear skin at Week 16, and had a beneficial secondary endpoint of achieving PASI 75 at Week 4 for psoriasis patients. The trial involved 679 moderate-to-severe plaque psoriasis patients and will be submitted for presentation at an international medical congress in 2015.
The study, dubbed CLEAR, is the second head-to-head trial conducted pitting Cosentyx against Stelara (ustekinumab). The first one, Phase III FIXTURE, demonstrated that Cosentyx was superior to another competitor, Enbrel (etanercept).
“We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors,” said Vasant Narasimhan, global head of development for Novartis. “Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx.”
Cosentyx is a human monoclonal antibody that works by neutralizing compound IL-17A, which is found in high concentrations in skin affected by psoriasis.
In addition, European Medicines Agency has recommended Cosentyx as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients in Europe. The agency cited data that showed that in Phase III studies, 70 percent or more of patients treated with Cosentyx 300 mg patients achieved clear or almost clear skin during the first 16 weeks of treatment.
Psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. World health agencies estimate that psoriasis affects up to 3 percent of the world’s population, or more than 125 million people, with as many as50 percent of those reporting discontent with current therapies, including biologic treatments.
