The Phase 2a DAISY proof-of-concept study evaluating the combination of nipocalimab with an anti-tumor necrosis factor alpha (anti-TNFα) therapy in rheumatoid arthritis (RA) patients with refractory disease was an innovative approach to test if the combination had the potential to be an effective option in this difficult-to-treat population. At 12 weeks, study results did not show sufficient evidence that the combination therapy provided significant added benefit over anti-TNFα therapy alone. Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA. No new safety concerns were found.
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
Editor’s note:
a. Non risk adjusted peak year operational sales
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.