Lilly/Incyte pill beats placebo in mid-stage eczema trial
(Corrects paragraph 11 to show that Dupixant was approved by FDA this year instead of last year)
By Deena Beasley
Sept 14 (Reuters) - Eli Lilly and Co and Incyte Corp on Thursday said a mid-stage trial of their oral drug baricitinib showed that at the highest dose it worked better than placebo for people with moderate-to-severe atopic dermatitis.
The finding could be a boost for the drug's prospects, which suffered a setback earlier this year after U.S. regulators turned down an application for its use in rheumatoid arthritis, saying that more data was needed.
Baricitinib, in a class of drugs known as Jak inhibitors, is sold in the European Union under the brand name Olumiant for treating rheumatoid arthritis.
Atopic dermatitis is a chronic type of skin inflammation also known as eczema, which in severe cases causes constant itching.
The Phase 2 eczema trial found that after 16 weeks, 61 percent of patients on the highest dose of baricitinib and a topical corticosteroid had at least a 50 percent reduction in symptoms, compared to 37 percent of patients treated with just a steroid. At the lower dose, there was not a significant difference between the groups.
Side effects included upper respiratory tract infections and headache.
The study, presented at the European Academy of Dermatology and Venereology annual meeting in Geneva, involved patients who had failed to achieve adequate relief after four weeks of using a mid-potency topical corticosteroid.
Baricitinib has the potential for use as an oral treatment for eczema patients who are unable to control the disease with a steroid, Dr Emma Guttman-Yassky, Vice Chair of the department of dermatology at Mount Sinai Hospital in New York, said in a statement.
Lilly and Incyte said they plan to launch a Phase 3 clinical program for atopic dermatitis later this year.
Rival AbbVie Inc last week said its experimental Jak inhibitor, upadacitinib, was shown in a mid-stage study to significantly improve the severity of eczema.
The U.S. medicines regulator, the Food and Drug Administration, earlier this year approved Regeneron Pharmaceuticals Inc and Sanofi SA's Dupixant for moderate-to-severe atopic dermatitis. However, sales of the drug, which has a list price of $37,000 a year, have so far disappointed investors.
Eczema affects an estimated 2 percent of U.S. adults, and as many as 20 percent of children.
(Reporting By Deena Beasley, Editing by Rosalba O'Brien)
