Inhalon Biopharma has announced that it is partnered with Celltrion to develop a nebulized formulation of regdanvimab, a monoclonal antibody for the treatment of COVID-19, which will be known as IN-006. In May 2021, Inhalon announced that it had been awarded a US Army contract worth $7 million for development of IN-006. The company says that a Phase 1 study of IN-006 is expected to be complete by the end of the year.
A Phase 3 study of IV regdanvimab (CT-P59) conducted by Celltrion demonstrated that it reduced the risk of hospitalization or death from COVID-19 by 70%. In vivo tests have shown that it has the ability to neutralize wild-type SARS-CoV-2 and variants of concern, including Alpha, Beta, Gamma, and Delta.
Celltrion Head of Medical Science Division SungHyun Kim said, “Working with Inhalon to develop an inhaled form of regdanvimab will allow us to more directly reach the virus in the airways where the infection begins. Regdanvimab will be the first antibody to be nebulized and inhaled against COVID-19 that has already demonstrated efficacy in a previous phase 3 study. This route of administration will diversify our delivery options and allow patients to self-administer treatment in the convenience of their own home.”
Inhalon President and CEO John B. Whelan commented, “As outbreaks and spikes in coronavirus cases continue to emerge, Inhalon’s partnership with Celltrion is a significant milestone for our inhaled muco-trapping platform, suggesting it has the potential to provide an easier and possibly more efficacious use of regdanvimab for COVID-19 patients. Celltrion’s regdanvimab has demonstrated efficacy against COVID-19 when delivered by IV administration and is under review by regulatory authorities in the US and Europe. With the financial support of the US Army Medical Research and Development Command, we will start the Phase 1 study of a nebulized formulation of regdanvimab in the next few months.”
Read the Inhalon Biopharma press release.
