AbbVie Announces the Launch of Robust Phase 3 Clinical Trial Program Evaluating ABT-494, an Investigational Selective JAK1 Inhibitor, for the Treatment of Rheumatoid Arthritis

- After positive results in the BALANCE Phase 2 trials, ABT-494, a second generation(1) oral selective JAK1 inhibitor, has moved into Phase 3 clinical trials for rheumatoid arthritis, starting in December 2015

- Five Phase 3 trials will evaluate over 4,000 patients with moderate to severe rheumatoid arthritis

Jan 08, 2016, 09:00 ET from AbbVie

NORTH CHICAGO, Ill., Jan. 8, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the start of a large Phase 3 clinical trial program to study the use of ABT-494, an investigational, once-daily, oral selective JAK1 inhibitor for the treatment of rheumatoid arthritis (RA). This program will include adult patients with inadequate responses (IR) to conventional or biologic disease-modifying antirheumatic drugs (DMARDs), as well as methotrexate-naive patients.

"We continue to leverage our expertise in rheumatology and immunology to address the unmet needs of patients living with immune-mediated diseases, including those that fail to respond to the current standard of care," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We are optimistic that our robust Phase 3 clinical trial program, which dosed the first patient in December, will help us further understand the therapeutic potential of ABT-494 across multiple patient populations and achieve our goal of providing patients with best-in-class treatment options."

Data from the Phase 2 ABT-494 clinical trials, BALANCE-I and BALANCE-2, announced in September 2015, demonstrated the efficacy of ABT-494 across 6, 12 and 18 mg doses twice-daily, and 24 mg once-daily in RA patients with an inadequate response to prior anti-tumor necrosis factor (TNF-IR) or methotrexate (MTX-IR) treatment.

The first two trials out of the five Phase 3 ABT-494 clinical trials have opened for enrollment in the United States. One study will evaluate ABT-494 in combination with MTX in adult patients with moderate to severely active RA who have had an inadequate response to prior treatment with MTX, and will include HUMIRA® (adalimumab) as an active comparator. The second study will include patients who have had an inadequate response or intolerance to conventional synthetic DMARDs. These studies will include assessments of safety and tolerability, as well as key measures of efficacy including ACR responses and levels of disease activity.

The other three Phase 3 clinical trials will begin enrollment in early 2016 and will include patients with an inadequate response to biologics and patients who are MTX-naive.

About the SELECT-COMPARE Clinical Trial
SELECT-COMPARE is a double-blind, placebo-controlled and active controlled Phase 3 study designed to evaluate the safety and efficacy of ABT-494 in combination with MTX in adult patients with moderate to severely active RA who have had an inadequate response to prior treatment with MTX. The trial duration is 48 weeks with a target enrollment of 1,500 patients.

About the SELECT-NEXT Clinical Trial
SELECT-NEXT is a double-blind, placebo-controlled, Phase 3 study designed to evaluate the safety and efficacy of two doses of ABT-494, 15 mg once-daily (QD) and 30 mg QD, in combination with conventional synthetic DMARDS. The study will enroll approximately 600 adult patients with moderate to severely active RA who have had an inadequate response or intolerance to conventional synthetic DMARDs.

For additional information on this clinical trial program, please visit www.clinicaltrials.gov.

About ABT-494
Pioneered by AbbVie, ABT-494 is an investigational, second generation, oral agent that selectively inhibits JAK1, which plays an important role in the inflammatory process of RA. A Phase 2 trial of ABT-494 for the treatment of Crohn's disease is also ongoing.

About AbbVie 
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements 
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

  1. Voss, Jeffrey, Graff, Candace, Schwartz, Annette, Hyland, Deborah, Argiriadi, Maria, Camp, Heidi, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10

 

SOURCE AbbVie



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