Incyte Corporation announced the presentation of clinical results from a 28-day Phase IIa trial of INCB18424, its orally available janus kinase (JAK) inhibitor, in patients with rheumatoid arthritis (RA).


Results from the 50-patient placebo-controlled trial demonstrated that three of the four doses of INCB18424 evaluated (15 mg BID, 25 mg BID and 50 mg QD) produced impressive clinical benefits and all of the doses were well tolerated. American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 response rates in the three most effective dose groups ranged from 50% to 83%, 40% to 50%, 25% to 30%, 10% to 17% respectively, and were achieved in one month, with responses seen as early as one week (see data summary below). Although there have been no head-to-head comparator trials, ACR 20/50/70 response rates with existing injectable biologic agents in larger studies typically average 60%/40%/20%, respectively, after 3 to 6 months of therapy.

The results were presented today in an oral presentation by Larry Moreland, M.D., Margaret Jane Miller Endowed Professor of Arthritis Research, Chief, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, and principal investigator of the study, during the “RA Treatment: Small Molecules and Gene Therapy” session at the 2008 American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific Meeting.

Dr. Moreland stated, “Results from this initial Phase IIa trial suggest that INCB18424, a novel oral JAK inhibitor, has the potential to be at least as effective as currently available RA therapies, including the widely used injectable biologicals. I look forward to participating in the next phase of clinical trials and seeing this new class of potent oral anti-inflammatory agents with an exciting mechanism of action progress through clinical development.”