The two Phase III trials are part of a five-trial package the companies are conducting to support potential regulatory approval for this indication.
Jonathan Weiss / Shutterstock.com
Two Phase III trials for atopic dermatitis therapy in development by Eli Lilly and Company and Incyte Corporation hit the mark at 16 weeks. The two late-stage studies are part of a five clinical trial study program aimed at determining the safety and efficacy of baricitinib in treating these patients.
This morning, Eli Lilly and Incyte said baricitinib hit the mark in BREEZE-AD1 and BREEZE-AD2, two Phase III studies evaluating baricitinib as a monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis. Moderate-to-severe AD is characterized by intense itching, resulting in visibly damaged skin and sleep loss.
Lilly’s announcement today was brief in the details. The company only noted that in both Phase III trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator’s Global Assessment for AD (IGA) score of clear or almost clear, in comparison to placebo. According to the scale, clear skin has a score of zero and almost clear skin as a score of one. The BREEZE-AD1 and BREEZE-AD2 trials are two of five studies that will be part of the placebo-controlled data program intended to support global registrations, Eli Lilly said. Full data results from the BREEZE-AD1 and BREEZE-AD2 trials will be shared at future conferences, as well as in peer-reviewed journals. Topline data from other ongoing Phase III trials expected later this year will also be shared, the company said.
Baricitinib has been approved as a treatment for moderately to severely active rheumatoid arthritis. It is sold under the brand name Olumiant. Olumiant is a once-daily, oral JAK inhibitor. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. Olumiant has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3, Eli Lilly noted.
In today’s announcement, the companies touted the safety results of baricitinib. At 16 weeks in both trials, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo. The most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.
Lotus Mallbris, head of immunology development at Eli Lilly, noted that there are limited treatment options, particularly oral treatments, for atopic dermatitis, an inflammatory skin disease.
“We are encouraged that baricitinib met the primary endpoints in these two studies, and look forward to seeing the collective results of all five studies,” Mallbris said in a statement.
