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JNJ-2113

Generic Name
JNJ-2113
Clinical Trials
Related News

Accropeutics' Oral TYK2/JAK1 Inhibitor Shows Strong Efficacy in Phase 2 Psoriasis Trial

• AC-201, an oral selective TYK2/JAK1 inhibitor, met its primary endpoint with up to 74.3% of patients achieving PASI-75 responses at week 12 across all three dosing regimens tested. • The drug demonstrated a favorable safety profile with no serious adverse events or discontinuations, positioning it as a potentially competitive option in the growing market for oral psoriasis treatments. • Based on these positive Phase 2 results, Accropeutics plans to advance AC-201 into Phase 3 development for plaque psoriasis, with potential applications in other autoimmune conditions.

FDA Grants Fast Track Designation for Johnson & Johnson's Nipocalimab in Sjögren's Disease

• The FDA has granted Fast Track Designation for Johnson & Johnson's nipocalimab to treat Sjögren's disease, following its earlier Breakthrough Therapy Designation, potentially accelerating development for this autoimmune condition. • Johnson & Johnson reported an 11% share price increase over the last quarter, bolstered by multiple regulatory milestones including Health Canada's approval for LAZCLUZE and positive results from the ANTHEM-UC study for ulcerative colitis. • Despite broader market volatility and a one-off $7.8 billion loss impacting recent financial results, J&J has maintained investor confidence through consistent dividend increases and strategic focus on its pharmaceutical portfolio.

Protagonist Therapeutics Reports Strong Financial Growth with Key Clinical Milestones Ahead in Q1 2025

• Protagonist Therapeutics secured a significant $165 million milestone payment for icotrokinra in Q4 2024, strengthening their financial position with total cash reserves of $559.2 million. • The company anticipates crucial Phase 3 VERIFY trial results for rusfertide in polycythemia vera and Phase 2b ANTHEM trial data for icotrokinra in ulcerative colitis by March 2025. • Protagonist advanced their pipeline with PN-881, a novel oral IL-17 receptor antagonist, while maintaining strong partnerships with Takeda and Johnson & Johnson for their lead programs.

J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200. • TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC). • Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy. • The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.

Rusfertide Achieves Primary Endpoint in Phase 3 VERIFY Trial for Polycythemia Vera

• Rusfertide significantly reduced the need for phlebotomies in polycythemia vera (PV) patients, with 77% achieving clinical response compared to 33% on placebo. • The VERIFY trial met all key secondary endpoints, including hematocrit control and improved patient-reported outcomes, demonstrating comprehensive efficacy. • The hepcidin mimetic was well-tolerated, with no new safety concerns, suggesting a favorable risk-benefit profile for PV patients. • Protagonist and Takeda plan to submit detailed results for presentation at upcoming medical conferences and to regulatory agencies for potential approval.

J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis

• Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis patients. • After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score. • Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo. • J&J plans to submit icotrokinra for regulatory approval, positioning it as a potential oral alternative to injectable biologics for psoriasis.

Icotrokinra Shows Promising Phase 3 Results for Plaque Psoriasis Treatment

• Phase 3 trials show Icotrokinra significantly improved skin clearance in adults and adolescents with moderate to severe plaque psoriasis. • At week 16, 64.7% of patients achieved clear or almost clear skin (IGA 0/1) with Icotrokinra, compared to 8.3% on placebo. • Icotrokinra, a once-daily oral peptide selectively blocking the IL-23 receptor, demonstrated a safety profile consistent with earlier studies. • Further improvements were seen at week 24, with 74.1% achieving IGA 0/1 and 64.9% achieving PASI 90, highlighting sustained efficacy.
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