ETH47 / Ethris - LARVOL DELTA

ETH47 is a novel mRNA drug candidate for the prevention of asthma exacerbations (ERS 2025) - "Nasal administration of ETH47 was safe, well tolerated and demonstrated dose-dependent target engagement in humans. Trial results support further clinical development of ETH47 as a novel preventer of asthma exacerbations."

Asthma • Immunology • Infectious Disease • Respiratory Diseases

Mucosal INFλ mRNA-based immunomodulation with ETH47 confers antiviral protection from influenza A and SARS-CoV-2 in vitro and in vivo (ERS 2025) - "ETH47 demonstrated antiviral efficiency against IAV and SARS-CoV-2 in vitro and in vivo. This data supports the development of ETH47 as a novel preventer of asthma exacerbations or as a first-line antiviral for pandemic preparedness."

Immunomodulating • Preclinical • Asthma • Immunology • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

ETH47-201: Phase IIa Trial in Participants With Asthma to Evaluate Impact of Intranasal ETH47 on Development of Asthma-related Symptoms Following Rhinovirus Challenge (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Ethris GmbH

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ETH47-101: A Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of ETH47 in Healthy Participants (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Ethris GmbH

New P1 trial

Ethris Presents Positive Topline Phase 1 Data with mRNA Lead Candidate ETH47 for Uncontrolled Asthma (Businesswire) - "Ethris GmbH...today announced promising topline data from the completed Phase 1 clinical trial of its lead mRNA therapeutic candidate, ETH47, in healthy volunteers....Safety and tolerability: ETH47 was generally safe and well tolerated across all dose levels, with no serious or severe adverse events and no adverse events leading to discontinuation reported in the healthy participants. The study also demonstrated no systemic bioavailability of the mRNA, the produced protein IFNλ, or the proprietary lipidoid compound, minimizing the risk of off-target effects....Based on the encouraging Phase 1 results, Ethris filed a Clinical Trial Application (CTA) for a Phase 2a rhinovirus challenge study in asthma patients, planned to begin in Q2 2025."

New P2a trial • P1 data • Asthma

Mucosal IFNλ1 mRNA-based immunomodulation effectively reduces SARS-CoV-2 induced mortality in mice. (PubMed, EMBO Rep) - "Here, we investigate the activity of lipidoid nanoparticle (LNP)-formulated mRNA encoding human IFNλ1 (ETH47), which is a critical driver of innate immunity at mucosal surfaces protecting from viral infections...These data support the development of inhaled administration of IFNλ1 mRNA as a potential prophylactic option for individuals exposed to SARS-CoV-2 or at risk suffering from COVID-19. Based on the broad antiviral activity of IFNλ1 regardless of virus or variant, this approach might also be utilized for other respiratory viral infections or pandemic preparedness."

Immunomodulating • Journal • Preclinical • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Ethris Announces $5 Million in Funding to Prepare Lead Candidate ETH47 for Phase 2 Study (Businesswire) - "Ethris GmbH...announced today that it has received funding from the Gates Foundation to support the advancement of the company’s lead mRNA-based product candidate, ETH47. This funding of $5 million includes an equity investment component expected to close at the company’s next financing round. The new capital will enable the company to rapidly reach Phase 2 readiness and build out the CMC manufacturing process for the next clinical trial...A Phase 1 study is ongoing with Ethris’ inhaled mRNA candidate ETH47 to evaluate safety, tolerability, and target engagement in healthy participants. A full data readout is planned for the third quarter of 2024."

Financing • P1 data • Infectious Disease • Respiratory Diseases

Ethris Initiates First-in-Human Dosing in Phase 1 Study of ETH47 for the Treatment of Virus-Induced Asthma (GlobeNewswire) - "Ethris GmbH...today announced the dosing of the first healthy participant in its first-in-human study of lead candidate ETH47...The Phase 1 study will primarily evaluate ETH47’s safety and tolerability in healthy participants....The study will be conducted at a single trial site in the UK and will enroll 88 healthy participants between the ages of 18 to 45....A full data readout is expected in the second quarter of 2024."

P1 data • Trial status • Asthma