Inhalon Biopharma Announces Positive Results from Study Demonstrating Superior Safety and Efficacy of its Inhaled Antibody Platform Over Systemic Dosing

2024-03-20

临床结果临床1期

DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections (ARI), today announced initial results from a landmark Phase 1b study that directly compares the distribution and retention of antibodies throughout the human respiratory tract following both inhaled and intravenous (IV) delivery. The study upends prevailing thinking about inhaled antibody delivery by demonstrating that antibodies maintain their activity following nebulization and can be dosed uniformly to all parts of the respiratory tract, including the deep lung. It also shows that inhaled antibodies can achieve concentrations throughout the respiratory tract greatly exceeding the levels required to neutralize most acute respiratory viruses. In the study, 20-fold higher concentrations of antiviral antibodies were observed in the respiratory tracts of subjects who received inhaled antibodies compared with subjects who received antibodies intravenously, despite subjects with inhaled dosing receiving up to 90% less antibodies. The study compared lung function in cohorts of normal healthy volunteers following treatment with either nebulization of Inhalon’s inhaled formulation or the same antibodies delivered intravenously. None of the study subjects in the inhaled treatment cohort experienced drug-related adverse events, and visual inspection of the subject’s lungs via bronchoscopy following five days of daily inhaled treatment did not show any signs of inflammation or medication-related lung damage. Further, there were no antidrug antibodies detected in the serum of subjects who received the inhaled treatments. There were less adverse events detected in subjects in the inhalation arms than in the IV arm. “The results of this study demonstrate the promise of inhaled antibodies as a potential at-home treatment for a broad range of ARIs including respiratory syncytial virus (RSV), human metapneumovirus (hMPV), influenza, and SARS variants,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “With this new evidence showing far superior exposure from inhaled antibodies, we will be advancing our pipeline into additional clinical studies.” Inhalon’s antibodies are designed to be self-administered by patients using a handheld portable nebulizer, making them easier to administer, store, and distribute compared to antibodies currently administered intravenously or by intramuscular injections. The greater convenience, dose savings and reduced burden on healthcare infrastructure supports initiating inhaled antibody treatment at the earliest time possible. The much greater antibody concentrations achieved in the respiratory tract with inhalation suggests the potential for even greater therapeutic effect. About Inhalon Biopharma Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC.

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