Clinical-stage pharmaceutical company ENA Respiratory has been awarded an additional $3.8 million contract from the US Department of Defence (DOD) to support ongoing research and development of INNA-051.
The investigative candidate is a first-in-class, intranasal, innate immune modulator in development to prevent complications associated with respiratory viral infections in at-risk populations.
The company also announced new clinical leadership and consultants as it plans for a seasonal prophylaxis Phase 2b study.
The new funding adds to the $4.38 million initial DOD funding the company announced in January 2023, which has been used to implement INNA-051 manufacturing on a larger scale.
The funds also supported the development of a dry powder formulation that is expected to provide long-term stability of at least 24 months at room temperature.
The company said the new funding will support the non-clinical toxicology and safety studies needed to enable a seasonal prophylaxis Phase 2b study to demonstrate the safety, tolerability, and efficacy of intranasal INNA-051 in preventing respiratory illness in people aged 65 or older.
“Early studies validated the safety of INNA-051 and provided proof of pharmacology by accelerating virus clearance and boosting host defence responses against common respiratory viruses,” said Christophe Demaison, co-founder and CEO of ENA Respiratory. “We are grateful for the U.S. DOD support and look forward to continuing to study INNA-051 in preventing respiratory illnesses, especially in those at greatest risk of exposure, complications, or hospitalisation.”
The company also announced new leadership and consultants to accelerate and optimize its research and development program.
Dr Ruth Tal-Singer joins as medicine development leader to oversee all clinical development efforts. Previously, Dr Tal-Singer was a consultant and board member for ENA Respiratory. She is a recognised scientist with extensive experience in molecular biology, immunology, and the application of digital technology and in vivo disease models in clinical development.
Dr Courtney Crimjoins as clinical consultant and acting chief medical officer. He also serves as a clinical associate professor of medicine in the Division of Pulmonary and Critical Care Medicine at the University of North Carolina in Chapel Hill.
Dr Bruce Miller joins the company as a clinical consultant with more than 30 years of experience developing therapies for COPD and other inflammatory-driven diseases.
“Our accomplished team brings decades of experience leading clinical research programs for respiratory diseases and successfully submitting new therapies for regulatory approvals in the U.S., Europe, and other regions,” said Dr Demaison. “With these additions to our team, we are well-positioned to continue the clinical development of INNA-051 in the context of natural respiratory tract infections in individuals with increased risk of severe illness or exposure.”
