Applied Molecular Transport Inc. announced top-line Phase 2 results from the LOMBARD monotherapy trial for AMT-101 in biologic-naïve and experienced patients with moderate-to-severe ulcerative colitis (UC). AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule. The clinical remission (CR) rate in patients treated with AMT-101 monotherapy was 17.1% (12/70 patients) compared to a CR rate of 20.0% (7/35 patients) with placebo, which was above the company’s baseline assumption for placebo CR rates based on published data in moderate-to-severe UC patients.

AMT remains focused on developing its two clinical assets: Preparing AMT-126 (oral fusion of IL-22) for a Phase 1b trial in patients with moderate-to-severely active UC. Exploring a strategic partnership to advance AMT-101 into Phase 3 in chronic pouchitis and concluding the ongoing AMT-101 Phase 2 CASTRO combination trial in patients with rheumatoid arthritis (RA). LOMBARD Results: In the LOMBARD trial, patients received once-daily oral AMT-101 3mg or placebo in a 2:1 ratio.

The objectives of the LOMBARD trial were to assess the safety and efficacy of AMT-101 in patients with moderate-to-severe UC. The key efficacy endpoint of clinical remission was measured at 12 weeks. Of the 105 patients, 17.1% (12/70) of patients treated in the monotherapy arm (AMT-101 3mg) achieved clinical remission versus 20.0% (7/35) in patients receiving placebo at week 12.

Clinical remission is defined as Mayo endoscopic subscore of 0 or 1 (blinded central read), rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1. AMT-101 was well-tolerated. Treatment emergent adverse events (TEAEs) were mostly mild to moderate and were generally balanced between the two arms.