CLAREMONT, Calif.--(BUSINESS WIRE)--Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced a partnership valued at up to $119 million over a six-year period with the Biomedical Advanced Research and Development Authority (BARDA), a center within the Administration for Strategic Preparedness and Response, part of the U.S. Department of Health and Human Services. This contract aims to develop Synedgen’s lead therapeutic, MIIST305, to address Gastrointestinal Acute Radiation Syndrome (GI-ARS) arising from acute exposure to ionizing radiation. The initial phase of the award provides up to $17 million for proof-of-concept studies in two animal models. If all options are exercised, this BARDA contract will advance MIIST305 development through U.S. Food and Drug Administration (FDA) approval and contribute to the field of medical countermeasures research by optimizing a new nonclinical GI-ARS model for FDA acceptance.
“We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GI-ARS,” said Shenda Baker, Ph.D., President and CEO of Synedgen. “No currently available FDA-approved therapeutic exists to provide protection to major gastrointestinal organs against acute exposure to ionizing radiation. Importantly, this program leverages Synedgen’s MIIST305 program to address gastrointestinal inflammation and damage from radiation, chemical or physiological sources, thus potentially meeting this unmet need.”
Synedgen has developed a drug design platform called Multivalent Innate Immune Signaling Target (MIIST) to identify and synthesize an innovative class of glycomedicines. MIIST305, derived from this platform, is a non-systemic therapeutic that modulates innate immune receptor responses and targets the anionic glycocalyx at the gastrointestinal cell surface to repair and restore the gut mucosal barrier. By doing so, MIIST305 is designed to mitigate the systemic hyperinflammation and dysbiosis that are characteristic of the gastrointestinal injury caused by acute radiation exposure. MIIST305 is shelf-stable and orally administered, obviating the need for specialized administration in an emergent scenario. In a Phase 1-ready program established independently of the partnership with BARDA, MIIST305 is also being developed as a therapy for ulcerative colitis (UC).
GI-ARS occurs when patients are exposed to a high level of radiation by sources which may be accidental or malicious in nature. ARS and UC are marked by similarities in disease pathophysiology, including mucosal barrier disruption, enterocyte death, activation of hyperinflammatory pathways, and dysbiosis. GI-ARS is a major radiation toxicity that can lead to sepsis and death. While there are four FDA approved products for hematopoietic acute radiation syndrome (H-ARS), there remains an unmet need for therapies that address GI-ARS. Together with BARDA, Synedgen is meeting this critical gap in national defense preparedness.
“Today’s announcement marks an important step in moving forward Synedgen’s innovative MIIST platform to produce therapies at the leading edge of medicine,” said LTC (retd.) Mark Bohannon, former Chief of the Medical Branch for the Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense (JRO-CBRND). “The development of MIIST305 as an FDA-approved GI-ARS therapeutic, in addition to its development as a UC drug, would be a major step forward in our efforts to improve not just civilian health but also provide a necessary option for furthering U.S. medical countermeasures against radiation threats.”
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About Synedgen, Inc.
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 therapy for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through National Institutes of Health grants and Department of Defense contracts. 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.
Contacts
Laurence Watts
619-916-7620
laurence@newstreetir.com
