Ethris reports positive mRNA drug data after new funding

German biotechnology company Ethris has reported promising initial Phase I data for its lead intranasal mRNA candidate, ETH47. The Phase I trial (ISRCTN15391202) results indicate that ETH47 is safe and well-tolerated with no significant adverse events across all tested dose levels. A comprehensive data readout is expected by the third quarter of 2024.

The announcement follows a recent update that Ethris has secured $5 million in funding from the Bill & Melinda Gates Foundation to support preparations for the Phase IIa study of ETH47, including critical chemistry, manufacturing, and control processes. Additionally, Cipla's European subsidiary announced an investment of €3 million ($3.2 million) in Ethris, adding to the €15 million investment made in 2022.

ETH47 is an mRNA that encodes type III interferon (IFN). The drug is designed to trigger an innate immune defense response in the mucosal tissue of virus entry points and inhibit viral replication. Ethris aims to use its Stabilised NanoParticle (SNaP) LNP platform to administer the drug directly to the lungs through inhalation or a nasal spray, exploring its potential as a broadly protective antiviral candidate for respiratory diseases.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ethris’s Phase I trial plan in November 2023 for healthy participants. These initial positive results are expected to bolster Ethris’s continued development towards human viral challenge studies, including a rhinovirus challenge study in individuals with mild asthma.

Uncontrolled asthma is one of the targeted indications for ETH47. This condition is characterized by persistent or worsening asthma symptoms despite ongoing treatment, suggesting inadequate management of the condition. Individuals with asthma are more susceptible to viral infections due to dysregulation of type III interferon. ETH47 may enhance mucosal immunity and correct low interferon levels, potentially improving the treatment for uncontrolled asthma.

Thomas Langenickel, Ethris’ chief medical officer, expressed optimism about the findings, stating: “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.”

In 2020, Ethris partnered with Neurimmune to develop mRNA-based neutralizing antibodies for a COVID-19 therapeutic designed for inhalation. This collaboration underscores the potential of mRNA technology in treating respiratory diseases, marking Ethris’s commitment to pioneering innovative treatments in this field.