INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib will be presented at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress taking place virtually October 29-31, 2020.
The data reinforce Lilly's commitment to developing medicines for the treatment of dermatologic diseases such as moderate to severe atopic dermatitis (AD). AD-also known as eczema-is a chronic inflammatory skin disorder that causes intense skin itching, redness, rash and sores.
At this year's virtual EADV meeting, data from BREEZE-AD3, a Phase 3 study evaluating the long-term efficacy and safety of baricitinib in adult patients with moderate to severe AD will be shared. In the study, responders as assessed by the validated Investigator Global Assessment score of 'clear or almost clear' skin (vIGA 0,1) and partial responders (vIGA 2) from one of the 16-week originating studies entered and continued treatment with baricitinib 2-mg or 4-mg once daily for an additional 52 weeks. At the start of BREEZE-AD3 (after 16 weeks of treatment in the originating studies), 45.7% of responders and partial responders on 4-mg of baricitinib had a vIGA-AD score of 0 or 1, while 40% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. Similarly, at the start of BREEZE-AD3 46.3% of responders and partial responders on 2-mg of baricitinib had a vIGA-AD score of 0 or 1, while 50% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. These results indicate that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period. The safety profile in this study was consistent with the known safety findings of baricitinib in previous 16-week, placebo-controlled AD studies.
'Baricitinib is part of a class of oral medicines called JAK inhibitors. These data support its potential use as a treatment for adults with moderate to severe AD,' said Jonathan Silverberg, director of clinical research at The George Washington University School of Medicine and Health Sciences. 'These results demonstrate that baricitinib's efficacy at achieving clear or almost clear skin could be sustained with continuous treatment.'
'At Lilly, we recognize the sacrifices that people living with dermatologic diseases like AD are making to address the symptoms of this chronic, relapsing skin disease,' said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. 'We're encouraged by the long-term baricitinib efficacy and safety data being presented at EADV, which reinforce the potential role this medicine could play in helping people living with AD.'
Earlier this week, Lilly announced baricitinib received approval in the European Union for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. The approved EU Product Information for baricitinib can be found here. Lilly has submitted these data to major regulatory authorities around the world and continues to interact with several regulators to seek approval for baricitinib as a medicine for AD.
About OLUMIANT
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Atopic Dermatitis
Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.6
Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8
About Lilly in Dermatology
By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with moderate to severe atopic dermatitis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee the future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful.
Contact:
Kevin Hern
Tel: 317-277-1838
Email: hernkevinr@lilly.com
ELI LILLY AND COMPANY 
