Inhalon Biopharma, a company in the clinical stage, has revealed initial findings from a pivotal Phase 1b clinical trial. The study, a first of its kind, compared how inhaled and intravenously injected antibodies are distributed and retained in the human respiratory system. The research indicated that nebulized antibodies remain effective and can be evenly administered throughout the respiratory tract, even reaching deep into the lungs. Notably, the inhaled method resulted in significantly higher antibody concentrations necessary to counter most acute respiratory viruses, with subjects receiving inhaled treatments showing 20 times the antiviral antibody levels compared to those who had intravenous injections, despite receiving a 90% lower dose.
Volunteers participating in the study were divided into groups and treated with Inhalon’s inhaled formulation or an equivalent dose via IV. The inhaled treatment group did not report any drug-related adverse events, and no signs of lung inflammation or damage were observed after five days of daily inhaled treatments. Additionally, no anti-drug antibodies were found in the serum of those who underwent inhalation therapy, and there were fewer adverse events in the inhalation group compared to the IV group.
John Whelan, CEO of Inhalon Biopharma, highlighted the potential of inhaled antibodies as a possible at-home treatment for various acute respiratory infections, including RSV, hMPV, influenza, and SARS variants. The company plans to move its pipeline into further clinical studies based on these promising results. Inhalon’s inhaled antibodies are designed for self-administration using a portable nebulizer, which simplifies administration, storage, and distribution. The convenience and reduced healthcare infrastructure burden of inhaled treatments could facilitate earlier intervention. The higher concentrations of antibodies in the respiratory tract suggest a more significant therapeutic impact.
Inhalon Biopharma, a privately held clinical-stage company, is focused on developing its proprietary inhaled antibody platform to treat acute respiratory infections. The company holds U.S. and EU patents for its technology and is backed by several investors and grants from the NIH and USAMRDC.
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