Inhalon Biopharma, Inc., a clinical-stage immunotherapy company developing an inhaled "muco-trapping" antibody platform for treating acute respiratory infections, today announced that the first patient has been dosed in a Phase 1 safety and tolerability study of IN-006 in healthy volunteers. IN-006 is an inhaled, muco-trapping formulation of regdanvimab. The study is being conducted in collaboration with Celltrion, Inc., which has already received Emergency Use Authorization (EUA) in several countries worldwide for its intravenous (IV) formulation of regdanvimab for the treatment of COVID-19. 

Inhalon's muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of infection and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Inhaled therapy can be readily self-administered by patients at home, extend critical drug supplies to more patients by reducing the dosage needed, and reduces the demand on healthcare staff and infusion clinic space that frequently accompanies IV drugs.

"There are very few options for treating patients diagnosed with COVID-19, and the concept of delivering an antibody directly to the lungs through inhaled technology has the potential to be of tremendous value to patients and health systems," said Dr. Jason Lickliter, MBBS, FRACP, principal investigator and Chief Medical Officer at Nucleus Network, Inc. "Delivering treatment through the IV route involves a number of resources, like time, infusion clinic resources, and larger doses of medication. The development of IN-006 combines a more convenient delivery method with a promising antibody therapy to offer a potential treatment that can be self-administered at home as an early and immediate intervention for patients recently diagnosed with COVID-19." 

Celltrion has demonstrated in a Phase 3 study that regdanvimab significantly reduced the risk of COVID-19-related hospitalization or death by 72% for patients at high-risk of progressing to severe COVID-19 and 70% for all patients. Regdanvimab has demonstrated efficacy against the most common variants in in vitro or in vivo studies, including the Alpha, Beta, Gamma and Delta variants.

"COVID-19 infections in both vaccinated and unvaccinated people continue to rise and place an enormous burden on healthcare workers and hospitals," said John B. Whelan, Inhalon's president and chief executive officer. "Inhalon's muco-trapping antibody technology is the only therapeutic modality that can actively clear infectious virus from the lungs via natural mucus clearance, thereby eliminating the source of inflammation and viral spread. Combining Inhalon's inhaled, muco-trapping platform with Celltrion's highly effective anti-SARS-CoV2 antibody will likely create a new treatment that patients can self-administer to free up valuable healthcare resources."

About the Study

The Phase 1, placebo-controlled, dose-escalation clinical trial of IN-006 is designed to assess the safety and tolerability of inhaled IN-006. The study is being funded in part by a contract awarded by the U.S. Army Medical Research & Development Command (USAMRDC). Please refer to www.anzctr.org.au for information about the clinical trial.

About Inhalon's "Muco-trapping" Immunotherapy Platform 

Although mucus in the lung airways is designed to protect the body from infections, pathogens have evolved to move easily through mucus to infect cells in the airways. Inhalon's breakthrough discovery enables inhaled antibodies to trap pathogens in mucus. These trapped pathogens are unable to spread or infect cells and are rapidly eliminated by normal mucus clearance in minutes – swept into the digestive tract where they are killed by stomach acid and can do no further damage. The muco-trapping technology was pioneered by Professor and Inhalon CSO Sam Lai at the University of North Carolina (UNC) at Chapel Hill, and licensed exclusively from UNC and Johns Hopkins University.

About Regdanvimab (CT-P59)

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralizing the SARS-CoV-2 virus. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralizes the wild type and mutant variants of concern, including the Alpha variant (B.1.1.7, first identified in the UK). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase 1 and 2 clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19. Celltrion also has recently commenced the development of a neutralizing antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

About Inhalon

Inhalon Biopharma is a clinical-stage immunotherapy company advancing an inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon's intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon is supported by the Thiel Foundation's Breakout Labs and angel investor syndicates led by Life Science Angels and others, including Band of Angels, Sand Hill Angels, Berkeley Catalyst Fund, as well as several federal contracts with the NIH and USAMRDC.

SOURCE Inhalon Biopharma