Inhalon Biopharma announced that a Phase 1b study that evaluated the company’s IN-006 nebulized regdanvimab in healthy volunteers demonstrated successful delivery of the inhaled antibodies throughout the respiratory tract, achieving uniform distribution and significantly higher concentrations than for intravenous regdanvimab. The study was funded by the United States Army Medical Research and Development Command.
Inhalon has been partnered with Celltrion on development of nebulized regdanvimab since 2021. Celltrion’s Regkirona IV regdanvimab is targeted at SARS-CoV-2 and is used in some countries for the treatment of COVID-19.
According to the study record in the ISRCTN registry, the Phase 1b study compared a single 90 mg dose of nebulized IN-006 or 90 mg of nebulized IN-006 once daily for 5 days to a single 40 mg dose of IV regdanvimab. Inhalon says that inhaled dosing delivered 90% fewer antibodies compared to intravenous but produced 20 times higher concentrations in the respiratory tract. The company also says that subjects who got inhaled antibodies experienced fewer adverse events than those who got the IV formulation, and no serious adverse events were recorded in the inhalation group.
Inhalon President and CEO John Whelan commented, “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. With this new evidence showing far superior exposure from inhaled antibodies, we will be advancing our pipeline into additional clinical studies.”
Read the Inhalon Biopharma press release.
