MIIST305 / Synedgen - LARVOL DELTA

Synedgen Announces Gut Microbes Publication of Preclinical Data Showing MIIST305 Mitigates Gastrointestinal Acute Radiation Syndrome Injury in a Murine Model (Businesswire) - "Synedgen, Inc...announced the publication of preclinical data that shows MIIST305 mitigating gastrointestinal acute radiation syndrome (GI-ARS) injury and ameliorating radiation-induced gut microbiome dysbiosis in a murine model....In this preclinical study, male C57BL/6J adult mice were exposed to 13 Gy partial body X-irradiation with 5% bone marrow shielding. MIIST305 was then administered on days 1, 3, and 5 post-irradiation. Approximately 85% of the animals survived the irradiation exposure and were apparently healthy until the end of the 30-day study period. In contrast, no control, vehicle-treated animals survived past day 10."

Preclinical • Gastrointestinal Disorder

MIIST305 mitigates gastrointestinal acute radiation syndrome injury and ameliorates radiation-induced gut microbiome dysbiosis. (PubMed, Gut Microbes) - "In summary, MIIST305 is a novel GI-targeted therapeutic that greatly enhances survival in mice exposed to lethal radiation and protects the GI tract from injury by restoring a balanced gut microbiota and reducing pro-inflammatory responses. Further development of this drug as an FDA-approved medical countermeasure is of critical importance."

Journal • Gastrointestinal Disorder • Immunology • Inflammation • Systemic Inflammatory Response Syndrome

MIIST305 mitigates gastrointestinal acute radiation syndrome injury and ameliorates radiation-induced gut microbiome dysbiosis. (PubMed, bioRxiv) - "In summary, MIIST305 is a novel GI-targeted therapeutic that greatly enhances survival in mice exposed to lethal radiation and protects the GI tract from injury by restoring a balanced gut microbiota and effectively reducing proinflammatory responses. Further development of this drug as an FDA-approved medical countermeasure will be of critical importance in the event of a radiation public health emergency."

Journal • Gastrointestinal Disorder • Immunology • Inflammation • Systemic Inflammatory Response Syndrome

Synedgen Completes IND-Enabling Studies for Two Parallel Programs for Lead Asset MIIST305 (Businesswire) - "Synedgen...announced it has completed IND-enabling studies for its lead candidate, MIIST305. MIIST305 is being developed for two parallel programs, an indication for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS). Within a year, Synedgen plans to open an Investigational New Drug (IND) application for MIIST305 and initiate a Phase 1 clinical study to support both programs....Phase 1 clinical studies expected to begin in 2025."

IND • Ulcerative Colitis