Applied Molecular Transport Inc (NASDAQ:AMTI) has announced topline Phase 2 results from the MARKET combination trial for AMT-101 in ulcerative colitis (UC).
- In the MARKET trial, patients received either AMT-101 3mg combined with AbbVie Inc's (NYSE:ABBV) Humira (adalimumab) or adalimumab alone (with placebo).
- The clinical remission rate in the adalimumab alone arm was higher than historical anti-TNFα monotherapy benchmarks.
- The data from the MARKET trial did not demonstrate added clinical benefit in the combination arm compared to the adalimumab alone arm at week 8.
- Of the 49 evaluable patients, 31.8% of patients treated in the combination arm achieved clinical remission versus 33.3% in patients receiving adalimumab alone at week 8.
- Sub-group analysis revealed that patients with a shorter duration of UC had clinical remission rates of 43.8% in the combination arm versus 15.4% in the adalimumab alone arm.
- In patients with longer duration, clinical remission rates were 0.0% in the combination arm versus 50.0% in the adalimumab alone group.
- These data suggest that AMT-101 combination treatment earlier in the course of UC may be more beneficial than anti-TNFα alone within five years of diagnosis.
- Price Action: AMTI shares are down 36.9% at $1.92 during the premarket session on the last check Wednesday.