Dive Brief:
- Clazakizumab is a mid-stage investigational human anti-interleukin (IL)-6 monocloncal antibody that is being developed for treatment of rheumatoid arthritis (RA) and psoriatic arthritis.
- Recently presented phase IIb data on clazakizumab suggests the drug is both safe and effective.
- Bristol-Myers Squibb’s decision to punt the drug back to Alder is not related to concerns about clazakizumab’s efficacy or safety, but rather the need to re-prioritize BMS's portfolio.
Dive Insight:
Based on phase IIb results, clazakizumab monotherapy and clazakizumab combined with methotrexate met the primary 12-week endpoints based on ACR20 scores. Remission rates were 23% for patients treated with combination therapy -- a better outcome than methotrexate combined with Humira (adalimumab), which had a remission rate of 8.5%.
Alder is continuing to focus on developing its portfolio of drugs and reviewing options for moving forward commercially with clazakizumab and its other potential winner, the migraine medication ALD403. "We view BMS's decision as a significant opportunity for Alder," said Randall Schatzman, president and CEO of Alder, in a statement. "This positions us with two programs with positive Phase II data for which we control the timelines and how we move forward with development."