Pharma Focus Europe

Ethris Secures Approval for Phase I Clinical Trial of ETH47, an Innovative Inhaled mRNA Solution for Respiratory Viral Infections

Wednesday, November 29, 2023

Ethris GmbH, a leading biotechnology company focused on advancing next-generation RNA therapeutics and vaccines, has secured approval from the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for the initiation of a Phase 1 clinical trial for its inhaled mRNA program, ETH47. The trial, targeting healthy participants for the treatment and prevention of respiratory viral infections, is scheduled to commence in the U.K. in December 2023. The MHRA's approval follows Ethris' submission of a Clinical Trial Authorization (CTA) application in June 2023.

Dr. Carsten Rudolph, Ethris' CEO, highlighted the significance of receiving regulatory clearance from the MHRA for ETH47, marking a noteworthy milestone for the company. He emphasized the importance of this phase in ETH47's development, bringing Ethris closer to delivering innovative solutions for addressing the unmet needs associated with respiratory viral infections, particularly among vulnerable populations and patients with underlying respiratory diseases like asthma or COPD.

The ETH47 program is supported by the BayTherapie2020 initiative of the German state of Bavaria, which aims to foster the development of innovative projects in the region.

ETH47, Ethris' pioneering mRNA-based product candidate, encodes type III interferon (IFN) and utilizes the company's Stabilized Non-Immunogenic mRNA (SNIM®RNA) platform. Administered locally to the lung through inhalation or nasal spray, ETH47 makes use of Ethris' proprietary Stabilized NanoParticle (SNaP) LNP platform. The objective is to induce a mucosal innate immune defense response at virus entry sites and inhibit viral replication. ETH47's versatile and mutation-independent mode of action holds promise for addressing a broad spectrum of seasonal and emerging respiratory virus infections, including those contributing to the exacerbation of chronic respiratory diseases like asthma.



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