MIIST-305

CLAREMONT, Calif.--( BUSINESS WIRE )--Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced that it has been awarded a $2.2 million contract from the Joint Warfighter Medical Research Program (JWMRP) for the development of its lead therapeutic, MIIST305, as a prophylactic radiation countermeasure. MIIST305 is an orally delivered, shelf-stable, gut-restricted therapy that promotes gut barrier regeneration and mitigates gastrointestinal-driven systemic hyperinflammation. MIIST305 is being developed by Synedgen as a treatment for Ulcerative Colitis (UC). With support from the Biomedical Advanced Research and Development Authority (BARDA), MIIST305 is additionally being developed as a medical countermeasure for acute radiation syndrome (ARS) when administered after acute exposure to ionizing radiation. The JWMRP contract furthers the understanding of MIIST305’s efficacy in preventing damage from radiation by administration before radiation exposure. The award will fund drug substance and drug product manufacturing for animal studies in two species to assess dose administration timing for optimal efficacy. “The risk of exposure to ionizing or nuclear radiation by military personnel, first responders and civilians is perhaps greater now than it has ever been. However, there is no available FDA approved therapeutic to provide protection from radiation injury to the gastrointestinal tract. We are developing MIIST305 to address this need and to provide prophylaxis for those who have anticipated radiation exposure,” said Shenda Baker, PhD, President and CEO of Synedgen. “In addition, we anticipate the results from this JWMRP funded program will also have important readthrough and benefits for our ulcerative colitis and post-exposure ARS programs.” “The gastrointestinal tract is among the most vulnerable tissues to radiation injury. In addition to weaponized or accidental radiation exposure, this type of gastrointestinal injury is also commonly observed in cancer patients who receive certain types of radiation treatments,” said Constantinos Broustas, Associate Professor of Radiation Oncology at Columbia University Vagelos College of Physicians and Surgeons and principal investigator of a study of the drug’s efficacy as a treatment after radiation exposure. “As a prophylactic treatment, MIIST305 could have far-ranging implications not just as a radiomitigating countermeasure, but also as a protective measure for oncology patients.” Although several FDA-approved drugs are available to counteract the later effects of hematopoietic acute radiation syndrome (H-ARS), no FDA-approved medical countermeasures have been approved to mitigate gastrointestinal radiation injury scenarios. In the case of gastrointestinal acute radiation syndrome (GI-ARS), radiation toxicity causes destruction of the intestinal epithelial barrier, allowing bacterial invasion into the mucus layer, causing inflammation, bacterial translocation, further damage to the GI tract, and death. MIIST305’s demonstrated activity the GI tract allows for development both as a potential prophylactic and post-exposure therapeutic for GI-ARS. 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 .