Eli Lilly‘s (NYSE:LLY) rheumatoid arthritis treatment developed by drug developer Incyte (NASDAQ:INCY) using oral janus-associated kinases, or JAK, inhibitors, has produced positive phase 2b results, according to a company statement.
The results were presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology.
The randomized double-blind, placebo-controlled, dose-ranging study, known as JADA, involved a total of 301 patients with active rheumatoid arthritis on stable doses of methotrexate across Eastern Europe, the U.S., India and Mexico. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib for 12 weeks.
Among the findings were baricitinib at 4 milligrams and 8 milligrams QD improved the signs and symptoms of rheumatoid arthritis over a 12-week period. There was significant difference against the placebo seen as early as week two for ACR20.
JAK inhibitors block the action of proteins called janus-associated kinases, which are involved in signaling cells. Only last year, Incyte had its first JAK inhibitor drug, Jakafi, approved by the U.S. Food and Drug Administration to treat myelofibrosis, a bone marrow disease.
Lilly’s drug looks set to compete with Pfizer (NYSE:PFE), whose JAK inhibitor treatment for rheumatoid arthritis, tofacitinib, was recommended for approval last month in an 8-2 vote by an FDA committee. Given that the FDA frequently follows committee recommendations, it will give Pfizer a decent amount of lead time to commercialize its drug before Lilly’s drug reaches the NDA submission stage.
Rheumatoid arthritis affects about 1.3 million people in the United States and 23.7 million globally, according to the World Health Organization.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Wilmington, Delaware-based Incyte inked the development and commercialization deal with Lilly in December 2009. In exchange for the worldwide rights to its oral JAK1/JAK2 inhibitor, INCB28050, and certain follow-on compounds, for inflammatory and autoimmune diseases, Incyte received an initial $90 million and could get up to $665 million for potential development, regulatory and commercialization milestones and royalty payments.
Incyte originated in Palo Alto, California but in 2004 relocated to Delaware, where it employed a team from DuPont Pharmaceuticals following Bristol Myers-Squibb’s $7.8 billion acquisition of the division in 2001.
