Ethris has dosed the first participant with its inhaled mRNA therapy ETH47 as part of a Phase I trial evaluating the candidate’s safety and tolerability in virus-induced asthma.
The first-in-human trial, which will enrol 88 healthy volunteers at a single site in the UK, has an expected full data readout in Q2 2024. The trial was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month.
Citing the drug’s broad applicability, the German biotech added that it could also be applied to pandemic responses against viruses such as influenza and SARS-CoV-2, according to an 18 December press release.
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 address a broad range of respiratory virus infections.
Though safety and tolerability are the main aims of the study, the randomised, placebo-controlled, double-blind, single-ascending dose trial will also determine the pharmacokinetics and target engagement of ETH47.
Using its Stabilised NanoParticle (SNaP) LNP platform for aerosol-based local administration, Ethris will investigate nasal and inhaled forms of ETH47, as well as delivery via a combination of the two.
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LNPs protect and deliver the active payload to the intended site. Upon dissolution, they release the dose of mRNA, which codes for the translation of therapeutic proteins. Ethris says its platform supports multi-route, multi-payload, and multi-cell type applications.
Respiratory viral infections are a common cause of asthma exacerbations. These respiratory attacks require emergency treatment. Experts say two-thirds of asthma deaths in the UK are preventable with better care including personal treatment plans, increased reviews, and prescription of more appropriate drugs. In 2019, asthma caused 455,000 deaths worldwide, according to the World Health Organization.
Ethris’ chief medical officer Dr Thomas Langenickel said: “Following promising preclinical results, we will evaluate ETH47 as a therapeutic and as a prophylactic medicine for prevention of severe disease following respiratory viral infections in patients with chronic respiratory disease such as asthma.”
ETH47 is Ethris’ most advanced candidate. The company has two other inhaled assets, ETH42 and ETH43, currently in preclinical studies for the treatment of primary ciliary dyskinesia – a disease that affects the function of respiratory tract cilia.
In the asthma treatment space, Aiolos bio launched with a $245m Series A round in October 2023. The biopharma is progressing its thymic stromal lymphopoietin (TSLP) antibody in Phase II trials.