Boehringer Ingelheim, one of the largest producers of biologic medicines in the world, recently announced that it has completed enrolling patients for its pivotal Phase 3 clinical trial (NCT02137226) evaluating BI-695501, a biosimilar drug candidate to adalimumab (AbbVie’s Humira), in patients with moderate to severe rheumatoid arthritis (RA).
The announcement followed data from its Phase I trial, recently discussed at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, that demonstrated the compound’s pharmacokinetic bioequivalence with both U.S.-licensed and EU-approved reference products.
The Phase 3 clinical trial is a randomized, double-blind, parallel arm, multiple dose, and active comparator trial in about 650 patients with a diagnosis of moderate to severe rheumatoid arthritis who are currently under treatment with methotrexate. Each patient is to be randomly assigned treatment with either BI-695501 or Humira every two weeks for a period of 48 weeks. The trial is expected to finish in October 2016.
Its primary endpoint is to establish an efficacy equivalence for the drug in RA patients, based on a statistical comparison of those meeting the American College of Rheumatology 20% (ACR20) response rate at week 12 and those meeting it at week 24.
The secondary endpoints will compare the efficacy, safety and immunogenicity of BI-695501 and Humira in RA patients, including those moving to BI-695501, after 24 weeks.
“We are excited to reach this important milestone for BI695501, which brings us closer to our goal of delivering new options to patients through our investigational biosimilars portfolio,” Peter Piliero, MD, vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim, said in a press release. “Our long-term commitment is to become a global leader in biosimilars, thereby supporting access to biologic medicines around the world.”
Humira (adalimumab) is a TNF inhibitor, anti-inflammatory drug which has been approved in the United States for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Rheumatoid arthritis patients using adalimumab have shown a response rate similar to methotrexate that, upon combination, nearly doubles the response rate of methotrexate alone.