MTAI-1025 / Montai Therapeutics - LARVOL DELTA

MTAI-1025: A First-in-Class Oral NRF2 Agonist Targeting the Pathogenic Drivers of Ulcerative Colitis (ACG 2026) - "MTAI-1025 dose-dependently reduced Disease Activity Index and body weight loss in the DSS model, with efficacy superior to anti-IL-12p40 blockade. Treatment improved mucosal architecture, reduced inflammatory cell infiltration, and lowered multiple cytokines. NRF2 pathway activation was confirmed by NQO1 mRNA induction."

First-in-human • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis • IL12A • IL23A • KEAP1 • NQO1

MTAI-1025: A FIRST-IN-CLASS ORAL NRF2 AGONIST TARGETING THE PATHOGENIC DRIVERS OF ULCERATIVE COLITIS (UEGW 2026) - No abstract available

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 1. first-in-human. randomized study to assess the safety. tolerability. and PK of single (SAD) and multiple (MAD) ascending doses of oral MTAl-1025 in healthy participants. (ANZCTR) - P1 | N=76 | Not yet recruiting | Sponsor: Montai Therapeutics, Inc.

First-in-human • New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Therapeutic Efficacy of a Novel Oral NRF2 Activator in a Murine Ulcerative Colitis Model (FOCIS 2026) - "Dose-dependent activation of the NRF2 transcriptional pathway was confirmed by induction of NQO1 mRNA. MTAI-1025 reduced cytokine secretion in MoDC cells and specifically regulated the dynamics of the NRF2/KEAP1/Cul3 complex at KEAP1 C151.ConclusionThese results demonstrate that MTAI-1025 effectively attenuates inflammation and exhibits efficacy in an in vivo model of UC, supporting its potential as a first-in-class oral NRF2-targeted therapy for UC."

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CXCL1 • IFNG • IL1B • IL6 • KEAP1 • NQO1

Therapeutic Efficacy of a Novel Oral NRF2 Activator in a Murine Ulcerative Colitis Model (IMMUNOLOGY 2026) - "These results demonstrate that MTAI-1025 effectively attenuates inflammation and exhibits efficacy in an in vivo model of UC, supporting its potential as a first-in-class oral NRF2-targeted therapy for UC."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis • CXCL1 • IFNG • IL1B • IL6 • KEAP1 • NQO1

Montai Therapeutics Presents Preclinical Data on NRF2 Agonist in Ulcerative Colitis at ACAAI Annual Meeting (Businesswire) - "Preclinical evaluations have indicated the candidate offers a highly promising profile to alleviate the inflammatory mechanisms of UC. Using a colitis mouse model, mice were treated over 14 days with MTAI-1025 (low, medium and high doses, oral daily), placebo, or an anti-IL-12p40 monoclonal antibody (mAb, 10 mg/kg, via intraperitoneal injection). MTAI-1025 elicited a clear dose-dependent reduction in key outcomes measures, such as the UC Disease Activity Index and weight loss, with better efficacy compared to the mAb. Analyses also revealed improved mucosal architecture and reduced inflammatory infiltration, with a marked reduction in pro-inflammatory cytokines, and confirmed NRF2 activation. Importantly, the tolerability profile was favorable with no signs of increased inflammation or necrosis."

Preclinical • Ulcerative Colitis