The clinical-stage biotech Applied Molecular Transport (NASDAQ:AMTI) dropped ~38% in the pre-market Wednesday after the company said its lead candidate AMT-101 failed to outperform in combination with AbbVie’s (ABBV) blockbuster drug Humira in a Phase 2 trial for ulcerative colitis (UC).
The MARKET study was designed to evaluate once-daily oral AMT-101 3mg in combination with adalimumab (Humira) or adalimumab alone (with placebo). Its key efficacy endpoint was the clinical remission at 8 weeks,
According to topline data, the combination arm was found to have no clinical benefit compared to the adalimumab monotherapy arm at week 8, Applied Molecular (AMTI) said.
Out of 49 evaluable patients, 31.8% (7/22) in the combination arm achieved clinical remission compared to 33.3% in the adalimumab monotherapy arm.
However, a post hoc sub-group analysis for patients with a shorter duration of UC (< 5 years) showed favorable clinical remission rates of 43.8% in the combination arm versus 15.4% for adalimumab monotherapy.
For those with longer duration UC (≥ 5 years), clinical remission rates stood at 0.0% (0/6) and 50.0% (7/14) for combination therapy and adalimumab monotherapy arms, respectively.
AMT-101 was found to be safe and well-tolerated with Treatment-emergent adverse events (TEAEs) being mostly mild to moderate. There was one serious adverse event (SAE), which was unrelated to the study drug.