Ethris Launches Initial Human Dosing in Phase 1 Clinical Trial of ETH47 for Virus-Induced Asthma Treatment
Monday, December 18, 2023
Ethris GmbH, a leading biotechnology company, has commenced the dosing of the first healthy participant in the Phase 1 human study for its primary candidate, ETH47. This candidate, developed using Ethris’ innovative Stabilized Non-Immunogenic mRNA (SNIM®RNA) platform, encodes for type III interferon (IFN), crucial for early antiviral responses. Notably, ETH47 is designed for local administration to the lung through inhalation or nasal spray, utilizing Ethris' proprietary Stabilized NanoParticle (SNaP) LNP platform. While the primary focus of the Phase 1 study is safety and tolerability in healthy participants, its potential application extends beyond virus-induced asthma to pandemic preparedness against influenza and SARS-CoV-2.
Dr. Thomas Langenickel, Chief Medical Officer of Ethris, highlighted the strategic approach behind ETH47, aiming to induce mucosal innate immune responses at viral entry sites with a mode of action independent of specific viruses and mutations. The initiation of the Phase 1 program represents a significant milestone for Ethris, reflecting the effectiveness of its platform technology. Building on promising preclinical results, ETH47 will be evaluated both as a therapeutic and a prophylactic medicine for preventing severe disease following respiratory viral infections in patients with chronic respiratory conditions like asthma.
The Phase 1 clinical trial, adopting a randomized, placebo-controlled, double-blind, single-ascending dose design, primarily assesses the safety and tolerability of ETH47. Additional objectives include evaluating its pharmacokinetics and target engagement. The study, conducted at a single trial site in the UK, aims to enroll 88 healthy participants aged 18 to 45. Delivery methods for ETH47 will be explored through nasal administration, inhalation, and a combination of nasal and inhaled delivery. Bayern Innovativ, an initiative of the German state of Bavaria, is providing partial funding for the trial. A comprehensive data readout is anticipated in the second quarter of 2024.
Viral asthma exacerbations, characterized by acute respiratory attacks necessitating emergency treatment, hospitalization, or systemic corticosteroids, pose a significant global health burden. These exacerbations result from respiratory airway inflammation triggered by environmental factors, with respiratory virus infections being the primary cause. Interferons, particularly type I (IFN-a/b) and type III (IFN-ls), play a pivotal role in mediating early antiviral responses. Current treatment options for viral asthma exacerbations include both quick-relief and long-acting medications aimed at reducing airway swelling.
Source: globenewswire.com
