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Trial Set to Test Inhaled mRNA for Viral Infections

Lung x-ray

Lung x-ray (Toubibe, Pixabay.

28 Nov. 2023. A developer of messenger RNA therapies for respiratory and rare diseases says it received clearance to begin a clinical trial in the U.K. for an inhaled treatment for viral lung conditions. Ethris GmbH in Munich, Germany says the Medicines and Healthcare Regulatory Agency or MHRA in the U.K. authorized a clinical trial of the company’s experimental drug code-named ETH47.

Ethris is a biotechnology company that creates therapies with synthetic messenger ribonucleic acid or mRNA, a single-stranded nucleic acid that carries instructions for making proteins from genetic codes in DNA to the nucleus of cells. In its natural state, says Ethris, mRNA is unstable in the body and can cause immune reactions. As a result, the company devised a technology for stabilized non-immunogenic mRNA, or SNIM-RNA, that it says overcomes these obstacles. Ethris says its mRNA treatments can be given repeatedly to patients to enable sustained production of therapeutic proteins in the body, or replace missing proteins.

SNIM-RNA therapies, says the company, are delivered with lipid or natural oil nanoscale particles that can cross cell membranes. Ethris says its lipid nanoparticle process makes it possible to administer mRNA treatments with aerosols to the upper and lower respiratory system. The company says it also can produce its treatments in freeze-dried form, which along with aerosol formulations, remain usable at room temperatures.

Proteins with immune defense against viruses

ETH47 is Ethris’s lead product, designed to treat viral infections in the respiratory tract. The company says ETH47 can be formulated as a nasal spray or given with an inhaler directly to the lungs. Ethris says ETH47 delivers mRNA with instructions to generate type 3 interferons, proteins providing an immune defense against viruses. Once in respiratory mucous membrane cells, says the company, ETH47 induces an innate immune response to stop viral entry and replication. Because ETH47 is designed to work independently of specific viruses, says Ethris, it can address a range of viral infections, including those triggering attacks from asthma.

The early-stage clinical trial authorized by MHRA is expected to enroll healthy participants for testing ETH47, and begin in December 2023. No further details about the study were disclosed.

“The trial start will be our first program to enter the clinic,” says Ethris CEO Carsten Rudolph in a company statement, adding this phase of ETH47’s development “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 company’s other programs are developing drugs for rare diseases with inhaled therapies, injections, and implanted treatments, as well as vaccines. In Sept. 2023, researchers at Ethris published a study in Nature Biomedical Engineering with colleagues from DIOSynVax in Cambridge, U.K. demonstrating in lab mice a vaccine protecting against a broad range of sarbecoviruses that include the zoonotic viruses responsible for Covid-19 infections and other pandemics.

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