Synedgen has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop its lead therapeutic, MIIST305, targeting gastrointestinal acute radiation syndrome (GI-ARS).
GI-ARS is a significant radiation toxicity that can result in sepsis and lead to death, especially when patients are exposed to high levels of radiation from accidental or malicious sources.
The deal, valued at up to $119m over six years, aims to fill a crucial gap in medical countermeasures for radiation exposure.
Synedgen's collaboration with BARDA begins with $17m dedicated to proof-of-concept studies in two animal models.
The successful completion of these studies could lead to further development of MIIST305 through US Food and Drug Administration (FDA) approval.
This partnership not only furthers the drug's development but also contributes to the optimisation of a new nonclinical model for GI-ARS that could gain FDA acceptance.
Synedgen president and CEO Shenda Baker stated: “We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GIARS.
“No currently available FDA-approved therapeutic exists to protect major gastrointestinal organs against acute exposure to ionising radiation. Importantly, this programme leverages Synedgen’s MIIST305 programme to address gastrointestinal inflammation and damage from radiation, chemical or physiological sources, thus potentially meeting this unmet need.”
Currently, there are four FDA-approved products to treat haematopoietic acute radiation syndrome (H-ARS), but no approved treatments for GI-ARS. The partnership between Synedgen and BARDA addresses this gap, enhancing national defence readiness against radiation-related injuries.
Synedgen's drug design platform, known as multivalent innate immune signalling target (MIIST), has been instrumental in the development of MIIST305. This non-systemic therapeutic works by modulating immune responses and targeting the gastrointestinal cell surface to repair and restore the gut mucosal barrier, mitigating the effects of radiation exposure.
Synedgen has also established a Phase I-ready programme for MIIST305 for ulcerative colitis treatment.
