Ethris Announces Positive Initial Phase 1 Data Demonstrating Nasal Delivery of mRNA Lead Candidate ETH47
June 25 2024 - 5:00AM
Business Wire
- ETH47 resulted in a dose-dependent increase in target protein
expression in the nasal cavity
- Nasal administration of ETH47 was generally safe and
well-tolerated, with no severe adverse events or drug-related
adverse events of clinical relevance
- Full data readout expected in the third quarter of 2024
- Following the Phase 1 study, Ethris plans to advance ETH47 for
patients with uncontrolled asthma
Ethris GmbH, a leading biotechnology company pioneering
next-generation RNA therapeutics and vaccines, announced today
preliminary positive data from its Phase 1 dose escalation clinical
trial evaluating the safety, tolerability, and target engagement of
lead mRNA candidate ETH47 encoding interferon lambda (IFNλ), in
healthy participants. IFNλ has a key role in viral immunity in the
respiratory tract. The data indicates that ETH47, administered
nasally, was generally safe and well-tolerated, with no severe
adverse events or drug-related adverse events of clinical relevance
across all dose levels. Initial results also show target engagement
and suggest no systemic biodistribution of ETH47. A full data
readout is planned for the third quarter of 2024.
“These preliminary results are highly encouraging as they
provide the first clinical validation of our innovative SNIM®RNA
platform and SNaP LNP technology, which allows localized
administration directly at virus entry sites and supports the
potential of ETH47 as a broadly protective antiviral candidate for
respiratory diseases,” said Dr. Thomas Langenickel, Chief
Medical Officer of Ethris. “We look forward to sharing
comprehensive Phase 1 data later this year as we continue
evaluating ETH47 for the treatment of uncontrolled asthma.
Furthermore, successful nasal delivery opens up mRNA therapeutics
as a new potential modality to treat diseases of the respiratory
tract.”
Uncontrolled asthma is a significant burden for patients,
including 4.4 million moderate to severe asthma patients in the US
alone. Approximately 80% of acute asthma attacks (exacerbations)
are associated with virus infections. Susceptibility to viral
infections in asthma is associated with dysregulation of IFNλ in
asthmatics. The promising safety and tolerability profile of ETH47
observed in the clinical trial, along with its potential to enhance
mucosal immune defense and correct low IFNλ levels, could represent
a significant advancement in the treatment landscape for
uncontrolled asthma.
Professor Eric Bateman, MD, Key Opinion Leader and Member of
the Board of the Global Initiative for Asthma (GINA) said,
“Given the strong association between viral infections, particular
with rhinovirus, and asthma exacerbations, Ethris’ mRNA product
candidate ETH47, with its unique mechanism of action has the
potential to fill a significant gap in the asthma treatment
paradigm.”
The Phase 1 trial is a randomized, placebo-controlled,
double-blind, single-ascending dose design to evaluate the safety
and tolerability of ETH47 in healthy participants. ETH47, Ethris’
lead candidate developed using the company’s proprietary
technologies was designed to address the unique challenges of
delivering mRNA to the lungs, including physiological barriers, low
transfection efficiency and delivery vehicle-induced inflammatory
responses. This initial data assessment indicates proof of
principle with ETH47 and supports its continued development toward
human viral challenge studies, including a rhinovirus challenge
study in mild asthmatics.
About Ethris
Ethris, a clinical-stage biotechnology company, has paved a new
path from genes to therapeutic proteins, using its proprietary RNA
and lipidoid nanoparticle technology platform to discover, design
and develop innovative therapies. With more than a decade as an
mRNA pioneer, Ethris is a global leader in delivering stabilized
mRNAs directly to the respiratory system via optimised formulation
and nebulisation technologies. The company is rapidly advancing its
mRNA pipeline of immuno-modulation, protein replacement therapies,
and differentiated vaccines, with the ultimate goal of improving
patients’ lives.
For more information, visit www.ethris.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240624540176/en/
For Ethris, please contact: Dr. Philipp Schreppel +49 89
244 153 042 schreppel@ethris.com