Ethris Reports Positive Phase 1 Data for Nasal mRNA Candidate ETH47

Ethris GmbH, a biotechnology company at the forefront of RNA therapeutics and vaccines, has announced promising early data from its Phase 1 clinical trial of ETH47. This candidate, which encodes interferon lambda (IFNλ), is being tested for safety, tolerability, and effectiveness in healthy individuals. IFNλ plays a crucial role in immune defense against respiratory viruses.

Preliminary findings from the study indicate that ETH47, administered via the nasal route, is generally safe and well-tolerated, showing no severe or clinically relevant adverse events. The data further reveal that ETH47 led to a dose-dependent increase in target protein expression in the nasal cavity without systemic biodistribution. The complete data from this Phase 1 trial is anticipated in the third quarter of 2024.

Dr. Thomas Langenickel, Chief Medical Officer of Ethris, expressed optimism about these preliminary results, which validate their SNIM®RNA platform and SNaP LNP technology. These technologies enable localized administration directly at the sites where viruses enter the body, supporting ETH47's potential as a broad-spectrum antiviral candidate for respiratory illnesses. Dr. Langenickel emphasized the importance of these findings in the ongoing evaluation of ETH47 for treating uncontrolled asthma and highlighted the potential for mRNA therapeutics to treat respiratory tract diseases.

Uncontrolled asthma poses a significant health challenge, affecting 4.4 million individuals with moderate to severe asthma in the United States alone. Virus infections are linked to roughly 80% of acute asthma attacks, and people with asthma often have dysregulated IFNλ responses. The safety profile of ETH47 observed in the trial, along with its potential to boost mucosal immune defense and correct low IFNλ levels, may represent a significant advancement in asthma treatment.

Professor Eric Bateman, a key opinion leader and board member of the Global Initiative for Asthma (GINA), remarked on the strong connection between viral infections, particularly rhinovirus, and asthma exacerbations. He highlighted ETH47's unique mechanism of action as a promising addition to the asthma treatment landscape.

The Phase 1 trial of ETH47 is a randomized, placebo-controlled, double-blind, single-ascending dose study aimed at evaluating the safety and tolerability of the candidate in healthy volunteers. ETH47 is Ethris’ lead candidate, developed using the company's proprietary technologies designed to overcome the unique challenges of delivering mRNA to the lungs. These challenges include physiological barriers, low transfection efficiency, and delivery vehicle-induced inflammatory responses. The early data from this trial indicate proof of principle with ETH47 and support its further development, including future human viral challenge studies such as a rhinovirus challenge study in mild asthmatics.

Ethris is a clinical-stage biotech company that has pioneered the transition from genes to therapeutic proteins using its own RNA and lipidoid nanoparticle technology platform. The company has been a leader in mRNA technology for over a decade, focusing on delivering stabilized mRNAs directly to the respiratory system through optimized formulation and nebulization technologies. Ethris is advancing its mRNA pipeline for immuno-modulation, protein replacement therapies, and differentiated vaccines, aiming to improve patient outcomes.

These developments mark a promising step toward new treatments for respiratory conditions, showcasing the potential of mRNA-based therapeutics in addressing unmet medical needs.