Ethris GmbH, a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, announced that it has received approval from the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with a phase 1 clinical trial for its inhaled mRNA programme, ETH47, in healthy participants for the treatment and prophylaxis of respiratory viral infections. The authorization follows Ethris’ submission of a Clinical Trial Authorization (CTA) application to the MHRA in June 2023. The phase 1 study is expected to commence in the UK already in December 2023.
“Receiving regulatory clearance from UK’s MHRA for our inhaled mRNA-based drug candidate ETH47 and its imminent entry into the clinic marks a significant milestone for Ethris” said Dr. Carsten Rudolph, CEO of Ethris. “The trial start will be our first program to enter the clinic and we look forward to this phase of ETH47’s development that brings us a step closer to providing innovative solutions that address the unmet need of respiratory viral infections, especially for the vulnerable population or patients with an underlying respiratory disease e.g., asthma or COPD.”
The ETH47 programme is supported by the BayTherapie2020 program, an initiative of the German state of Bavaria that supports the development of innovative projects and initiatives in the region.
ETH47 is Ethris’ first-in-class mRNA-based product candidate encoding type III interferon (IFN) that was developed using the company’s Stabilized Non-Immunogenic mRNA (SNIM RNA) platform, and uniquely designed to be administered locally to the lung through inhalation or nasal spray using Ethris’ proprietary Stabilized NanoParticle (SNaP) LNP platform. ETH47 is meant to induce a mucosal innate immune defense response at virus entry sites as well as inhibit viral replication. ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections including virus-driven exacerbation of chronic respiratory diseases such as asthma.
Ethris has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design and develop innovative therapies.
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