regulatory
confidence high
sentiment positive
materiality 0.70
FDA accepts MyMD IND for Phase 2 study of oral TNF-α inhibitor MYMD-1 in rheumatoid arthritis
Q/C TECHNOLOGIES, INC.
- FDA acceptance allows Phase 2 trial in RA; MyMD will discuss timing with CRO IQVIA.
- MYMD-1 is an oral TNF-α inhibitor; existing TNF-α inhibitors require injection or infusion.
- Prior Phase 2 sarcopenia/frailty data showed statistical reduction in TNF-α, IL-6, sTNFR1.
- Company claims MYMD-1 blocks both TNF-α and IL-6, differentiating from current RA treatments.
- Plans to initiate Phase 3 trials in sarcopenia; if approved, first FDA-approved drug for sarcopenia.