Synedgen has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop MIIST305, a therapeutic targeting gastrointestinal acute radiation syndrome (GI-ARS). The deal, potentially worth up to $119 million over six years, seeks to address a critical gap in medical countermeasures for radiation exposure, particularly from accidental or malicious sources.
GI-ARS is a significant radiation toxicity that can lead to sepsis and death, especially following high levels of radiation exposure. Currently, there are four FDA-approved products to treat haematopoietic acute radiation syndrome (H-ARS), but no approved treatments for GI-ARS, highlighting a critical unmet need in radiation injury treatment.
The collaboration between Synedgen and BARDA will commence with $17 million allocated to proof-of-concept studies in two animal models. Successful completion of these studies could pave the way for further development of MIIST305 and its potential FDA approval. This partnership also aims to optimize a new nonclinical model for GI-ARS, potentially gaining FDA acceptance.
MIIST305: A Novel Therapeutic Approach
Synedgen's drug design platform, known as multivalent innate immune signalling target (MIIST), has been instrumental in developing MIIST305. This non-systemic therapeutic modulates immune responses and targets the gastrointestinal cell surface to repair and restore the gut mucosal barrier, mitigating the effects of radiation exposure. The therapeutic is also in a Phase I-ready programme for ulcerative colitis treatment.
According to Synedgen president and CEO Shenda Baker, "We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GIARS... 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."
Addressing an Unmet Medical Need
The partnership between Synedgen and BARDA addresses a significant gap in national defense readiness against radiation-related injuries. With no currently available FDA-approved therapeutic to protect major gastrointestinal organs against acute exposure to ionizing radiation, MIIST305 represents a promising solution to enhance the medical countermeasure landscape.
