In the hunt to develop targeted drugs against plaque psoriasis, Amgen ($AMGN) and Eli Lilly ($LLY) both said their experimental biologics met the main goals of their respective mid-stage studies. And the positive data from the studies, both reported in the prestigious New England Journal of Medicine, have helped propel Lilly's and Amgen's programs into Phase III territory.
Both companies' drugs are monoclonal antibodies that target interleukin-17, a culprit in the inflammation that occurs in diseases such as plaque psoriasis, which is a chronic skin ailment that triggers the formation of red, scaly patches on the body.
Indianapolis-based Lilly said its ixekizumab offering passed the main test of the 142-patient trial, with way more patients on the drug achieving at least a 75% improvement in their Psoriasis Area and Severity Index scores versus those in the placebo camp at week 12. The study showed that 82% of patients on the 150-mg dose, 83% on the 75-mg dose and 77% on the 25-mg dose had a 75% improvement, compared with 8% in the placebo group after 12 weeks.
Some of the most frequent adverse events in patients on Lilly's treatment included respiratory inflammation, respiratory infections, headaches and reactions at the injection site.
In Thousand Oaks, CA-based Amgen's mid-stage trial of brodalumab in 198 patients, the study met the top goal with the drug providing an improvement in disease score for patients on all doses versus placebo. There was an average improvement of 85.9% in those who took 140-mg dose, 86.3% in patients on 210-mg dose and 45% in people on a 70-mg dose compared with 16% in the placebo group.
The most common side effects among patients on Amgen's drug were common cold, respiratory infections and irritation around the injection site. Two cases of neutropenia were also reported in patients on the 210-mg dose of the drug.
Amgen, of course, already markets its blockbuster antibody drug Enbrel for treating psoriasis. Yet companies are pursuing more targeted treatments that could quell the side effects related to existing therapies. There's a large potential market. According to Amgen, 80% of the 125 million people who suffer from psoriasis have the plaque version of the disease.
"Treatment with antibodies targeting interleukin-17 or its receptor should be more specific and may be expected to result in fewer side effects and therefore holds promise for patients with psoriasis," wrote Ari Waisman of the Johannes-Gutenberg University of Mainz in Germany in his commentary for the NEJM, as quoted by MedPage Today.
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