The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ethris’s Phase I trial to investigate its inhaled mRNA candidate ETH47.
The first-in-human trial will evaluate the safety, tolerability, and target engagement of the candidate in healthy participants for the treatment and prophylaxis of respiratory viral infections.
The trial is expected to start in December 2023, according to a press release on 28 November.
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 has the ability to address a broad range of respiratory virus infections.
The German biotech is using its Stabilised NanoParticle (SNaP) LNP platform to locally administer the drug to the lungs through inhalation or nasal spray.
Ethris highlighted infectious diseases such as influenza and Covid-19 as targets for the drug. It also pointed to limiting the exacerbation that viruses can exert on chronic respiratory conditions such as asthma.
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Ethris CEO Dr Carsten Rudolph said: “The trial start will be our first programme 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 for respiratory viral infections, especially for the vulnerable population or patients with an underlying respiratory disease.”
ETH47 is Ethris’ most advanced candidate. Two other inhaled assets, ETH42 and ETH43, are currently in preclinical studies for the treatment of primary ciliary dyskinesia. The company also has other assets, including vaccines, in the discovery phase for diseases, including hepatitis C, ischemic heart disease, and neurodegenerative conditions.
Earlier this month, Ethris partnered with King’s College London spin-out HEQET Therapeutics to develop non-coding RNA-based therapeutics for heart conditions.
In January 2023, the biotech raised €15m ($16.4m) after a strategic deal with Cipla EU, a subsidiary of Indian pharmaceutical company Cipla.
Around one in six people in the UK reported influenza-like illness (ILI) symptoms between May and June 2023, according to the Office for National Statistics.
There has been a lot of recent development in other infectious diseases such as respiratory syncytial virus (RSV). Last month, GSK released new preliminary data from a Phase III trial investigating Arexvy in adults aged 50-59. GSK aims to be the first company to submit data on this patient population to regulators.