Applied Molecular Shares Tumble After Disappointing Data From Mid-Stage Ulcerative Colitis Study

Applied Molecular Transport Inc 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 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.