Applied Molecular's Ulcerative Colitis Candidate Fails To Separate From Placebo In Untreated Patients

Applied Molecular Transport Inc AMTI announced topline Phase 2 results from the LOMBARD monotherapy trial for AMT-101 in biologic-naïve and experienced patients with moderate-to-severe ulcerative colitis (UC).
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.
The company noted similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12.
Related: Applied Molecular Shares Tumble After Disappointing Data From Mid-Stage Ulcerative Colitis Study.
"We will be seeking a partner to advance AMT-101 in chronic pouchitis into Phase 3 and look forward to presenting additional pouchitis data at the European Crohn's and Colitis Organisation meeting in March 2023," said Bittoo Kanwar, chief medical officer of AMT.
Tahir Mahmood, CEO & 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."
"We remain focused on stepwise execution and will be judicious in deploying our resources and extending our cash runway," Mahmood added.
AMT-101 was well-tolerated. Treatment-emergent adverse events (TEAEs) were mainly mild to moderate and were generally balanced between the two arms.
Price Action: AMTI shares closed 10.7% down at $0.92 during after-hours trading on Thursday.

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Applied Molecular's Ulcerative Colitis Candidate Fails To Separate From Placebo In Untreated Patients