LMT503 / Lmito Therap, Samyang Group - LARVOL DELTA

LMT503 First-in-human SAD, MAD, and FE Study (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Lmito Therapeutics Inc. | Trial completion date: Mar 2026 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Sep 2027

First-in-human • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

NQO1-Mediated Immunometabolic Reprogramming by LMT503 Restores T Cell Plasticity and Restrains Neutrophil Pathogenicity in Colitis (FOCIS 2026) - "We hypothesized that pharmacological NQO1 activation would resolve intestinal inflammation by coordinately modulating T cell plasticity and neutrophil effector functions. Therapeutic efficacy of LMT503 was assessed in an adoptive T cell transfer-induced colitis model and compared with the JAK inhibitor tofacitinib. These findings identify NQO1 activation as a metabolic chekpoint that governs T cell plasticity and innate cell pathogenicity. LMT503-mediated NQO1 activation represents a promising immunometabolic strategy for IBD, by suppressing inflammation while promoting mucosal immune tolerance."

Immunology • Inflammation • Inflammatory Bowel Disease • CD177 • CD4 • CEACAM8 • FOXP3 • IL2 • IL22 • NQO1 • PPARGC1A • STAT5

NAD+ modulation of intestinal macrophages renders anti-inflammatory functionality and ameliorates gut inflammation. (PubMed, Biomed Pharmacother) - "Depletion of CX3CR1 expressing gut resident macrophages abrogated the immune regulatory effect of LMT503 in the colon. These data suggest that LMT503 is a therapeutic candidate that can target macrophages to drive polarization with an immunosuppressive character and ameliorate IBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CX3CR1 • IL10 • IL6 • MRC1 • NQO1 • SIRT1 • SIRT3 • SIRT6 • TNFA

LMT503 First-in-human SAD, MAD, and FE Study (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Lmito Therapeutics Inc. | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Anti -Inflammatory Effect of LMT503, a Modulator of Immune Cell Metabolism, on Murine Adoptive T Cell Transfer -Induced Colitis Model (IMKASID 2024) - "Conclusion : Our data suggest that the anti-inflammatory effect of LMT503 ameliorates murine adoptive T cell transfer-induced colitis by modulating cellular metabolism and immune cell modulation. Therefore, LMT503 may represent a novel therapeutic drug that opens new avenues for the treatment of IBD."

Immune cell • Preclinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL2RA • ISG20 • RAG1

LMT503 First-in-human SAD, MAD, and FE Study (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Lmito Therapeutics Inc. | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

LMT503 First-in-human SAD, MAD, and FE Study (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Lmito Therapeutics Inc. | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

ANTI-INFLAMMATORY EFFECT OF LMT503, A MODULATOR OF CELL METABOLISM, AMELIORATES MURINE ADOPTIVE T CELL TRANSFER-INDUCED COLITIS (UEGW 2023) - "Our data suggest that the anti-inflammatory effect of LMT503 ameliorates murine adoptive T cell transfer-induced colitis by modulating cellular metabolism and immune cell modulation. Therefore, LMT503 may be a novel therapeutic drug that opens new avenues for the treatment of IBD."

Preclinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IFNG • IL1B • IL2 • IL2RA • IL6 • ISG20 • MPO • PPARGC1A • RAG1 • TNFA

LMT503, A NOVEL THERAPY FOR INFLAMMATORY BOWEL DISEASE THROUGH MACROPHAGE POLARIZATIONS BY METABOLIC REPROGRAMMING OF ACTIVATED MACROPHAGE (CCCongress 2023) - "In summary, LMT503 was very efficacious in various IBD in vivo models with showing the resolution of intestinal inflammation and mucosal healing through improved epithelial restitution via macrophage polarizations, and this approach can be a very effective and safe therapy for multifaceted IBD. The first in human study with LMT503 will be initiating in 4Q 2022."

Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CD68 • CD80 • CD86 • IL10 • IL18 • IL1B • IL22 • IL6 • MRC1 • TNFA

LMT503 First-in-human SAD, MAD, and FE Study (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Lmito Therapeutics Inc.

New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis