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MyMD Pharma gains FDA clearance for Phase 2 trial of oral MYMD-1 in rheumatoid arthritis
Q/C TECHNOLOGIES, INC.
- FDA cleared IND for Phase 2 trial of oral MYMD-1 (TNF-α inhibitor) in rheumatoid arthritis.
- Trial planned for Q1 2024; will enroll ~60 patients with active RA at 1050 mg oral dose.
- Preclinical data: MYMD-1 reduced disease severity by 47% vs 37% for Enbrel (etanercept).
- MYMD-1 could become first FDA-approved orally administered TNF-α inhibitor for RA.
- RA affects ~1.5M Americans with annual societal cost estimated over $40 billion.