Synedgen Announces Gut Microbes Publication of Preclinical Data Showing MIIST305 Mitigates Gastrointestinal Acute Radiation Syndrome Injury in a Murine Model

Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today 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. The paper has been published in Gut Microbes and is coauthored by Synedgen and its research collaborators at Columbia University’s Center for Radiological Research. You can read the full article here.

“In our study, MIIST305 greatly enhanced the survival of mice exposed to lethal radiation and protected the GI tract from injury by restoring a balanced gut microbiota and effectively reducing proinflammatory responses,” said Dr. Constantinos G. Broustas, Associate Professor of Radiation Oncology (in the Center for Radiological Research) at Columbia University Vagelos College of Physicians and Surgeons. “Based on this and other data, further development of this drug is warranted, especially given the lack of FDA-approved countermeasures to treat GI-ARS.”

High-dose radiation exposure is known to result in gastrointestinal (GI) acute radiation syndrome injury and currently there are no FDA-approved countermeasures that can treat this condition. To meet this unmet need, Synedgen has developed a glycopolymer radiomitigator (MIIST305) that is specifically targeted to the GI tract and acts by intercalating into the mucus layer and the glycocalyx of intestinal epithelial cells that can potentially ameliorate the deleterious effects of radiation.

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.

MIIST305 improved intestinal epithelial barrier function and suppressed systemic inflammatory response mediated by radiation-induced pro-inflammatory cytokines. Furthermore, taxonomic profiling and community structure of the fecal and colonic mucosa microbiota demonstrated that MIIST305 treatment increased microbial diversity and restored an abundance of beneficial commensal bacteria, including Lactobacillus and Bifidobacterium genera, while suppressing potentially pathogenic bacteria compared with vehicle-treated animals.

About MIIST

Synedgen’s Multivalent Innate Immune Signaling Target (MIIST) platform targets receptors in the glycocalyx, a key to human innate immunity. Historically an underappreciated target in drug development, the glycocalyx is becoming more recognized as the key to intestinal homeostasis. Developed with extensive peer-review and funding from government partners, the MIIST platform is being used to advance a diverse array of therapeutics promoting mucosal barrier protection and regeneration. The Company is continuing to develop its GI-ARS program with support from key partnering agencies in the United States government.

About Synedgen

Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx targeted induction and maintenance therapy for ulcerative colitis (UC). With US Government support, MIIST305 is also being developed in parallel as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through twenty-two (22) National Institutes of Health grants and Department of Defense contracts. Synedgen has an in-house GMP manufacturing facility. For more information, please visit www.synedgen.com. Synedgen’s GI-ARS program is funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority, under Contract No. 75A50124C00047. For more information, please visit www.synedgen.com.

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