According to ENA Respiratory, the FDA has cleared the company’s IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral nasal spray. ENA said that it expects the study to begin in mid-2024. Development of the dry powder formulation is partially funded by the US Department of Defense Chemical and Biological Defense Program.
ENA Respiratory CEO Christophe Demaison commented, “We are pleased that the FDA has cleared our IND for our dry powder formulation of INNA-051, which is expected to provide extended shelf life at room temperature. FDA clearance is a significant milestone for the company as it supports late-stage clinical development of INNA-051.”
Medicine Development Leader Ruth Tal-Singer said, “The study is an essential step in supporting our planned international seasonal prophylaxis Phase 2b study in older adults at risk of severe complications from viral respiratory diseases due to conditions including diabetes, cardiovascular or lung diseases. By targeting the innate immune system at the primary site of most viral respiratory infections, INNA-051 has the potential to address an unmet need in this most vulnerable population as a complementary virus-agnostic approach to available vaccines and direct-acting antivirals, which are often virus-specific.”
Read the ENA Respiratory press release.
