Synedgen, Inc., a biotechnology company specializing in gastrointestinal disease treatment, has secured a $2.2 million contract from the Joint Warfighter Medical Research Program (JWMRP). The funding will support the development of MIIST305, a promising therapeutic, as a preventative measure against radiation exposure. This builds upon previous research and development of MIIST305 for radiation mitigation and ulcerative colitis treatment.
MIIST305 is an orally administered, shelf-stable therapy designed to regenerate the gut barrier and mitigate systemic hyperinflammation originating in the gastrointestinal tract. Synedgen is developing MIIST305 for ulcerative colitis treatment and, with support from the Biomedical Advanced Research and Development Authority (BARDA), as a medical countermeasure for acute radiation syndrome (ARS) after radiation exposure. This new JWMRP contract will explore MIIST305’s potential to prevent radiation damage when administered proactively. The funds will facilitate drug substance and product manufacturing for animal studies, focusing on optimal dosage timing for maximum effectiveness.
This research addresses a critical unmet need for an FDA-approved therapeutic to protect the gastrointestinal tract from radiation injury, a risk faced by military personnel, first responders, and civilians. The findings from this JWMRP-funded program are expected to benefit ongoing ulcerative colitis and post-exposure ARS research programs. The gastrointestinal tract is highly susceptible to radiation damage, a common side effect observed in cancer patients undergoing radiation therapy. As a prophylactic treatment, MIIST305 holds significant potential as a radiation countermeasure and a protective agent for oncology patients.
Currently, no FDA-approved medical countermeasures exist to mitigate gastrointestinal radiation injury, although several drugs are available to address the later effects of hematopoietic acute radiation syndrome (H-ARS). In gastrointestinal acute radiation syndrome (GI-ARS), radiation toxicity destroys the intestinal epithelial barrier, leading to bacterial invasion, inflammation, and, ultimately, death. MIIST305’s demonstrated activity in the GI tract positions it as a potential preventative and post-exposure therapeutic for GI-ARS.
Synedgen’s Multivalent Innate Immune Signaling Target (MIIST) platform focuses on receptors in the glycocalyx, a crucial component of human innate immunity and increasingly recognized for its role in intestinal homeostasis. Developed with substantial peer review and government funding, the MIIST platform advances therapeutics for mucosal barrier protection and regeneration. Synedgen continues to advance its GI-ARS program with support from key US government agencies and maintains an in-house GMP manufacturing facility. The GI-ARS program receives funding from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response (ASPR), and the Biomedical Advanced Research and Development Authority.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
