German biotechnology company Ethris has announced initial positive Phase I data demonstrating the safety of its lead intranasal mRNA candidate ETH47.
The data from the Phase I trial (ISRCTN15391202) shows that ETH47, when administered nasally, was safe and well tolerated, with no severe adverse events or drug-related adverse events of clinical relevance across all dose levels. A full data readout is expected in the third quarter of 2024.
This follows an announcement from last week that Ethris secured $5m in funding from the Bill & Melinda Gates Foundation to support preparations for ETH47’s Phase IIa study including chemistry, manufacturing and controls (CMC) processes.
In addition to this, on 18 June, Cipla announced that its wholly owned subsidiary, Cipla (EU), will invest an additional €3m ($3.2m) in Ethris, following a €15m investment back in 2022.
ETH47 is a type III interferon (IFN)-encoding mRNA. The drug induces an innate immune defence response in the mucosa at virus entry sites. It can also inhibit viral replication, with Ethris stating the drug can be a broadly protective antiviral candidate for respiratory diseases. The German biotech company is using its Stabilised NanoParticle (SNaP) LNP platform to locally administer the drug to the lungs through inhalation or nasal spray.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ethris’s Phase I trial plan back in November 2023 for healthy participants. These initial positive results will support Ethris in its continued development towards human viral challenge studies, including a rhinovirus challenge study in mild asthmatics.
Ethris has also highlighted uncontrolled asthma as a target indication for the drug. This is a condition where asthma symptoms persist or worsen despite treatment, indicating that the current management is not effectively controlling the symptoms. Asthmatics are more prone to viral infections due to dysregulation in interferon type III. ETH47 may boost mucosal immunity and correct low interferon levels, potentially improving treatment for uncontrolled asthma, according to the company.
Ethris’ chief medical officer Thomas Langenickel said: “We look forward to sharing comprehensive Phase I data later this year as we continue evaluating ETH47 for the treatment of uncontrolled asthma. Furthermore, successful nasal delivery opens up mRNA therapeutics as a new potential modality to treat diseases of the respiratory tract.”
Ethris teamed up with Neurimmune back in 2020 to develop mRNA-based, neutralising antibodies for a Covid-19 therapeutic formulated for inhalation.
