AbbVie begins late stage trials of rheumatoid arthritis drug
pharmafile | January 11, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | ABT-494, AbbVie, F-star, JAK-1 inhibitor, rheumatoid arthritis
AbbVie has begun a large phase III clinical trial programme for its next-generation rheumatoid arthritis (RA) treatment ABT-494, which the company believes could be a future best-in-class therapy for the condition.
The JAK1 inhibitor, which impressed in Phase II trials last year, is viewed as a potential successor to AbbVie’s bestselling blockbuster Humira (adalimumab), which is expected to come under increased competition in 2016, with the expiry of its main patent in the US.
Data from the Phase II clinical trials, BALANCE-I and BALANCE-2, were announced in September 2015. The studies found that ABT-494 was effective across 6, 12 and 18 mg doses twice-daily, and also at the 24 mg once-daily dase in RA patients who had an inadequate response to prior treatments.
AbbVie has focused on the promising drug as it prepares for life after Humira, since pulling out of a licensing agreement with Galapagos last year for filgotinib – a similar JAK-1 inhibitor. The move surprised some at the time, and Gilead Sciences stepped in at the end of 2015, paying $725 million for the rights to the Belgian biotech’s drug.
The Phase III programme will consist of five trials, and the first two have now opened for enrolment in the US. They will assess safety and tolerability, as key measures of efficacy including ACR responses and levels of disease activity. The other three phase III clinical trials will begin enrolment in early 2016.
“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,” says Scott Brun, vice president, pharmaceutical development, AbbVie.
“We are optimistic that our robust Phase III 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.”
It comes as AbbVie announced a collaboration and license agreement with F-star, a clinical-stage company developing bispecific antibody immuno-oncology products to treat cancer, to research and develop bispecific antibodies in immuno-oncology. Financial terms for the deal have not been disclosed.
“We are very excited to be working with AbbVie on these immuno-oncology programmes to develop new bispecific antibodies,” says John Haurum, chief executive of F-star. “Bispecific antibodies are expected to be the cornerstone of the next generation of immuno-oncology products and this collaboration validates our technology as truly novel and differentiated in the space.”
Joel Levy
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