CAMBRIDGE, Mass. — Montai Therapeutics, a biotechnology company using artificial intelligence to develop medicines for chronic diseases, has completed dosing participants in the first cohort of a Phase 1 clinical trial evaluating MTAI-1025, an experimental oral treatment for ulcerative colitis.
The milestone marks the first time a therapeutic candidate developed using Montai’s AI-driven CONECTA platform has entered clinical testing. The company expects initial trial results by mid-2027.
MTAI-1025 is designed to selectively activate NRF2, a protein that regulates cellular responses to oxidative stress and inflammation. The investigational drug aims to address three interconnected factors associated with ulcerative colitis: intestinal inflammation, oxidative stress and dysfunction of the intestinal epithelial barrier.
According to Montai, preclinical studies demonstrated favorable tolerability and potential therapeutic activity, including dose-dependent improvements in disease activity and tissue pathology compared with standard anti-IL-12/IL-23 monoclonal antibodies.
“Dosing the first participants with MTAI-1025 is an important milestone for Montai, marking the translation of our CONECTA platform from discovery into the clinic,” said Dr. Lamya Shihabuddin, Chief Scientific Officer of Montai Therapeutics.
“Current therapies for ulcerative colitis primarily target inflammation, yet epithelial barrier dysfunction and oxidative stress are also central components of disease biology. MTAI-1025 was designed to address these interconnected mechanisms through selective NRF2 activation, creating the potential for a differentiated oral treatment for patients with UC that could break the efficacy ceiling that limits current therapies.”
The randomized, placebo-controlled Phase 1 study will evaluate single and multiple ascending doses of MTAI-1025 in healthy volunteers. Researchers will assess the drug’s safety, tolerability, pharmacokinetics and exploratory measures of NRF2 pathway activation.
Participants will be randomly assigned in a 3:1 ratio to receive either MTAI-1025 or a placebo.
Montai is developing a pipeline of oral therapies for chronic inflammatory diseases using its CONECTA platform, which combines artificial intelligence with the discovery of previously unexplored chemical compounds.
MTAI-1025 is the first candidate from the company’s pipeline to advance into human clinical trials. Its safety and effectiveness in patients with ulcerative colitis have not yet been established.
