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Inhalon Biopharma Announces Publication of Phase 1 Clinical Trial Data for IN-006, Its Inhaled Antibody Treatment for COVID-19
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Data published in eBioMedicine shows safety and tolerability of inhaled antibody dosing modality while achieving high nasal and serum antibody concentrations
Study highlights potential of self-administered inhaled antibody therapies to address a broad range of respiratory infections
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​Durham, North Carolina, February 26, 2025 — Inhalon Biopharma (Inhalon), a clinical-stage company advancing a first-in-class inhaled antibody platform for treating acute respiratory infections (ARI), today announced the publication of its Phase 1 study of IN-006, a potential treatment for COVID-19, in eBioMedicine. The data showed both the safety of self-administered inhaled antibody dosing, and the potential advantages of this modality compared with traditional intravenous methods of monoclonal antibody delivery.
“These findings provide strong evidence of the safety and potential utility of a nebulized, inhaled antibody therapy to treat respiratory infections,” said John Whelan, chief executive officer of Inhalon Biopharma. “Our therapeutic approach was shown to overcome many of the major challenges associated with the intravenous administration of monoclonal antibody therapies, not only suggesting the potential for our approach to be effective in treating COVID-19, but also pointing to its utility for other common respiratory infections including influenza and RSV (respiratory syncytial virus).”
The randomized controlled clinical trial was the first human study of Inhalon’s inhaled antibody treatment approach. The study was conducted in late 2021 in a population of 23 healthy adults randomly assigned to three cohorts with some receiving the therapeutic and others receiving a placebo. Subjects treated with IN-006 had few side effects and achieved high nasal and serum concentrations with self-administration. Subjects also sustained high antibody concentration in nasal fluid up to 24 hours after the medication was administered, suggesting the potential for once-daily therapeutic dosing.
“Evidence collected to-date suggests that inhaled antibodies are a safe alternative to systemically delivered antibodies and offer the potential to inexpensively and more effectively treat patients with respiratory infections in their own homes,” said Sam Lai, Ph.D., founder of Inhalon Biopharma and professor, Division of Pharmacoengineering and Molecular Pharmaceutics at the University of North Carolina. “As our medical system prepares for future outbreaks of respiratory infections, Inhalon’s inhaled antibody-based therapeutics could be a game-changer for patient adherence while reducing the burden of care on an overtaxed healthcare system.”
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About Inhalon Biopharma
Inhalon Biopharma, Inc. is a private, clinical-stage company advancing a first-in-class inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes 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 grants from the NIH and USAMRDC.
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John Whelan
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