Inhalon Biopharma Announces Two Publications Advancing its Inhaled Antibody Treatment Platform for Acute Respiratory Infections

Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections. The data, published in Advanced Science and in Bioengineering and Translational Medicine, underscore the potential therapeutic benefits from leveraging inhaled delivery of antibodies to treat a range of acute respiratory infections, including not only RSV and SARS-CoV-2 variants, but also influenza, human metapneumovirus (hMPV), and parainfluenza (PIV).

“Inhalon’s approach rethinks the use of antibodies for the treatment of acute respiratory infections by delivering antibodies directly to the site of the infection,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “Our studies in Advanced Science and in Bioengineering and Translational Medicine demonstrate the exceptional effectiveness of our inhaled antibody platform, which offers the potential to treat a wide array of acute respiratory infections. With the results from these studies, we are advancing candidates against RSV and all variants of SARS-CoV-2 into the clinic.”

There remains a high unmet need for new outpatient treatments for acute respiratory infections despite the availability of vaccines for influenza, RSV, and COVID-19. The U.S. Centers for Disease Control and Prevention estimates that 360,000 people were hospitalized with influenza during the 2022-2023 season.¹ RSV is responsible for 58,000-80,000 hospitalizations in children ages five and under, as well as 60,000-160,000 hospitalizations in older adults every year.² While COVID-19 is harder to estimate on an annual basis, there are currently more than 15,000 hospitalizations per week in the U.S.³

The preclinical data published in Advanced Science evaluates the efficacy of treating an established RSV infection with inhaled antibodies. In the study, RSV-infected neonatal lambs received daily nebulized delivery of Mota-MT, Inhalon’s muco-trapping antibody against RSV. Treatment was delayed until three days post infection when the virus was at peak levels in the lung. Following three days of once-per-day nebulized treatment, Mota-MT reduced viral load by 10,000-fold to 100,000-fold compared to the placebo group, with most animals exhibiting no detectable virus in the respiratory tract. This directly correlated with reduced inflammation, bronchiolitis, neutrophil infiltration, and airway remodeling; the lungs of many animals treated with Mota-MT appeared no different than uninfected animals, despite the very late initiation and short duration of treatment. Inhalon has completed IND-enabling studies with a derivative of Mota-MT and is planning to start a Phase 1 study later this year.

The study published in Bioengineering and Translational Medicine assesses the efficacy of a muco-trapping ACE2-(G₄S)₆-FC decoy that binds and neutralizes SARS-CoV-2, without risk of viral escape. The molecule has shown picomolar potencies against all strains of SARS-CoV-2 tested, including Omicron variants. In the study, hamsters that received intranasal dosing as late as two days post infection saw at least a ten-fold viral load decrease by day four. With the support of the USAMRDC, Inhalon has begun preclinical activities and manufacturing to advance this candidate into the clinic in 2025.

About Inhalon Biopharma

Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved 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 federal grants from the NIH and USAMRDC.

The muco-trapping mAb technology, Mota-MT and the ACE2-(G4S)6-FC decoy were originally developed by Prof. Sam Lai at the University of North Carolina (UNC) - Chapel Hill, and licensed exclusively by Inhalon.

1. Centers for Disease Control and Prevention, “Burden of Flu.” Available: https://www.cdc.gov/flu/about/burden/index.html.
2. Centers for Disease Control and Prevention, “Respiratory Syncytial Virtus Infection (RSV).” Available: https://www.cdc.gov/rsv/index.html.
3. Centers for Disease Control and Prevention, “COVID Data Tracker.” Available: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.

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