Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis
– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12
– AMT-101 was well-tolerated
– Planned Phase 1b trial for the company’s second clinical asset, AMT-126, in UC patients
– Exploring strategic partnership options to advance AMT-101 into Phase 3 in patients with chronic pouchitis
– Strong cash position of $76M reported in Q3 2022
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) — Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today 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.
“We thank our patients and sites for participating in the LOMBARD trial. While we are disappointed with the top-line results, we are seeking to better understand the unexpectedly high placebo rate of clinical remission in this moderate-to-severe population,” said Bittoo Kanwar, M.D., chief medical officer of AMT. “Separately, we continue to be encouraged by the positive data generated with AMT-101 in chronic pouchitis, which has been granted Orphan Drug Designation in this indication. We will be seeking a partner to advance this program into Phase 3 and look forward to presenting additional pouchitis data at the European Crohn’s and Colitis Organisation meeting in March 2023.”
Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT, added, “Our platform technology has generated two clinical assets, and we look forward to advancing AMT-126, an oral fusion of AMT’s proprietary carrier molecule and IL-22, which is a validated target, into a planned Phase 1b trial in UC.
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