New at-home RSV treatment represents a potential breakthrough in addressing the burden of respiratory diseases, especially in vulnerable pediatric and elderly populations
nhalon Biopharma, Inc. (Inhalon), a clinical-stage company advancing a first-in-class inhaled antibody platform for treating acute respiratory infections (ARI), today announced the completion of IND-enabling studies for its respiratory syncytial virus (RSV) candidate, IN-002, and plans to advance its inhaled-antibody therapy into a human challenge study in 2026. The company also announced a contract with hVIVO (AIM: HVO), a fast-growing specialist contract research organization and the world leader in human challenge trials, to conduct the Phase 2a trial.
Inhalon’s RSV candidate is one of several potential therapies being developed based on the company’s inhaled antibody technology for acute respiratory infections. The inhaled route of administration delivers therapeutic antibodies directly to the site of infection in the airways using a handheld nebulizer, rather than dosing treatments via oral or intravenous methods. Multiple animal models have shown the inhaled treatment approach to be much more effective at treating respiratory infections, making it likely to reduce costs and ease the burden of care on patients and the health care system.
“The treatment paradigm for respiratory infections is ripe for disruptive innovation. Preventive immunizations are underutilized, especially in RSV, where vaccine usage is now expected to be one-third of original estimates. As many as 30-50% of immunized patients experience breakthrough infection, leaving vulnerable populations – infants, toddlers, and the elderly – at high risk of severe infection. There are currently no approved treatments for the underlying RSV infection,” said John Whelan, president and chief executive officer of Inhalon Biopharma. “Inhalon’s inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections, but also provides painless, self-administration by patients in their own homes, potentially reducing hospitalizations.”
A prior clinical study1 comparing an Inhalon-developed inhaled antibody therapy and an antibody therapy approved for intravenous use demonstrated that Inhalon’s antibodies maintain full activity following nebulization and can be dosed uniformly to all parts of the respiratory tract, including the deep lung. The study found 30-fold to 100-fold higher concentrations of the antiviral antibody in the respiratory tracts of subjects who received inhaled dosing compared to subjects dosed intravenously, despite subjects with inhaled dosing receiving up to 90% fewer antibodies.
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