Johnson & Johnson has announced results from its Phase 2a DAISY proof-of-concept study, which evaluated the combination of nipocalimab with an anti-tumor necrosis factor alpha (anti-TNFα) therapy in patients with rheumatoid arthritis (RA) who have refractory disease. The study aimed to determine if this combination could be a more effective treatment option for this group of patients.
After 12 weeks, the data did not show that the combination therapy provided significant added benefit compared to anti-TNFα therapy alone. As a result, Johnson & Johnson will not continue clinical development of nipocalimab in combination with anti-TNFα therapy for RA. The company reported that no new safety concerns were identified during the study.
Despite these findings, Johnson & Johnson stated: "We are excited to continue the ongoing clinical development program evaluating nipocalimab in potential indications across Rheumatic, Rare Autoantibody and Maternal Fetal diseases. We remain confident in the nipocalimab product having $5B+ potential.a"
The company also included a note clarifying that the $5 billion figure refers to non risk adjusted peak year operational sales.
In addition, Johnson & Johnson cautioned investors and readers about forward-looking statements related to product development and future benefits of nipocalimab. The company pointed out various risks and uncertainties associated with drug research and commercialization, including regulatory approvals, manufacturing challenges, competition, changes in healthcare regulations, and market trends. More information on these risks can be found in their filings with the Securities and Exchange Commission at www.sec.gov or www.jnj.com.