Phase 1 clinical trial results look promising for ETH47, a new drug that could help treat uncontrolled asthma and other respiratory diseases. German biotechnology company Ethris recently released the data from its phase 1 dose escalation clinical trial, “Data Demonstrating Nasal Delivery of mRNA Lead Candidate ETH47.”
According to the results, ETH47 was safe and well tolerated when administered nasally, with no severe adverse events or drug-related adverse events of clinical relevance across all dose levels. Nasal delivery opens up mRNA therapeutics as a new potential modality to treat diseases of the respiratory tract.
“Given the strong association between viral infections, particularly with rhinovirus, and asthma exacerbations, Ethris’ mRNA product candidate ETH47, with its unique mechanism of action, has the potential to fill a significant gap in the asthma treatment paradigm,” said Eric Bateman, MD, a professor of pulmonology at the University of Cape Town in South Africa and a key opinion leader and member of the board of the Global Initiative for Asthma (GINA).
Ethris is preparing to move the drug to phase 2 trials with funding assistance from the Bill & Melinda Gates Foundation. The $5 million grant will support chemistry, manufacturing and control (CMC) processes.
ETH47 is an mRNA, type III encoding interferon lambda (IFNλ) drug that induces a protective immune response in the mucosa at virus entry points. The antiviral may be a significant therapeutic plan for multiple respiratory diseases and is delivered through the nasal passages via Ethris’ proprietary Stabilised NanoParticle (SNaP) LNP platform. There are unique challenges of delivering mRNA drugs to the lungs, including physiological barriers, low transfection efficiency and delivery vehicle-induced inflammatory responses.
The ETH47 phase 1 clinical trial was approved in the United Kingdom in November 2023 for healthy participants. Ethris said it hopes to continue the drug’s development to positively impact human viral challenge studies, including a rhinovirus challenge study in participants with mild asthma.
