Rhinovirus infection

Treat underlying cause of COPD versus maintaining status quo of expensive, chronic therapies COLLEGE PARK, Ga., March 19, 2025 /PRNewswire/ -- Altesa BioSciences, Inc., a clinical-stage pharmaceutical company dedicated to developing new treatments for viral infections in vulnerable populations, today announced that the U.S. Food and Drug Administration (FDA) has cleared Altesa's new Investigational New Drug (IND) application for vapendavir for the treatment of rhinovirus infections in people living with COPD. This milestone paves the way for Altesa to initiate clinical trials in the United States for this patient population. "Viral infections are the primary cause of acute deteriorations in lung function and overall health for those living with COPD. Among viral causes, rhinovirus -- the predominant cause of the common cold -- is the most frequent," said Dr. Brett Giroir, CEO of Altesa BioSciences and former US Assistant Secretary for Health and former Acting FDA Commissioner. "The new IND allows us to advance our studies in COPD, already ongoing in the United Kingdom, into the United States." Altesa already has an open IND for vapendavir to treat rhinovirus infections in people with asthma." Vapendavir, taken orally in pill form, is a broad-spectrum antiviral medicine that prevents the virus from entering human cells and reproducing. It exhibits potent activity across 97% of rhinoviruses and other respiratory enteroviruses. Altesa BioSciences holds exclusive global rights to develop, manufacture, and commercialize vapendavir. More than 16.4 million Americans, or 6.6% of U.S. adults, suffer with COPD, which is now among the leading causes of death in the US and globally. Those with limited financial resources, especially those in urban and rural areas, are often diagnosed late, which is associated with worse overall outcomes. In developing vapendavir, Altesa is applying Dr. Giroir's lessons learned from leading testing and diagnostics for the White House Coronavirus Task Force in 2020. Specifically, he said, "our investments in widely accessible diagnostics now enable treatment of the right patient, at the right time, with the right medicine." It is time to apply these lessons to viral infections that cause suffering in our vulnerable populations every year. Vapendavir, Dr. Giroir continued, also holds strong promise to help other patient groups, including those with asthma, other lung diseases, and cancer, and for treating rhinovirus infections in children – a leading cause of pediatric hospitalizations. Altesa's goal is to prevent acute and chronic complications of viral infections in people at risk, and to disrupt the current paradigm of costly, chronic, immune-modifying therapies by instead treating the underlying cause of the acute disease. For Media Inquiries Contact: Mia Heck Cellular: 210.284.0388 Email: [email protected] SOURCE Altesa Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MUNICH, Germany I January 30, 2025 I Ethris GmbH , a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced promising topline data from the completed Phase 1 clinical trial of its lead mRNA therapeutic candidate, ETH47, in healthy volunteers. Designed to address the upstream trigger of asthma exacerbations, ETH47 encodes interferon lambda (IFNλ), a protein essential for viral immunity in the respiratory tract. These topline results provide the first clinical validation of Ethris’ pioneering targeted RNA therapeutic approach and its ability to induce a downstream cascade of antiviral interferon-stimulated genes locally following nasal administration. Thomas Langenickel, MD, Chief Medical Officer at Ethris, presented the results on January 30 th , 2025, at the mRNA-Based Therapeutics Summit Europe in Frankfurt, Germany. “These positive Phase 1 results reinforce the promise of ETH47 as a potentially safe and transformative treatment option for asthma patients, while also validating our SNIM ® and SNaP ® proprietary technology platforms as a viable delivery option for mRNA therapeutics to the respiratory tract,” said Dr. Thomas Langenickel, Chief Medical Officer at Ethris. “This significant milestone demonstrates the ability of our technology to deliver precisely designed mRNA candidates to the respiratory tract, facilitating production of the encoded protein and engagement with the intended target. With this strong foundation, we look forward to advancing ETH47 into Phase 2 trials in 2025 and remain committed to exploring its potential to transform care for patients with asthma and broader respiratory conditions.” The Phase 1 study assessed the safety, tolerability, and target engagement of ETH47 after nasal administration in 40 healthy participants. Key Results from the Phase 1 Study: 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. This upcoming trial will focus on evaluating the ability of ETH47 to reduce lower respiratory symptoms in asthma patients following rhinovirus infection. About ETH47 ETH47 is Ethris’ first-in-class mRNA-based product candidate encoding interferon lambda (IFNλ) that was developed using the company’s Stabilized Non-Immunogenic mRNA (SNIM ® RNA) platform, and uniquely designed to be administered locally to the respiratory tract through inhalation or nasal spray using Ethris’ proprietary Stabilized NanoParticle (SNaP ® ) LNP platform. ETH47 is meant to induce a mucosal innate immune defense response at virus entry sites as well as inhibit viral replication. ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections, including virus-driven exacerbation of chronic respiratory diseases such as asthma. About Uncontrolled Asthma 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. Asthma exacerbations cause excessive inflammation and mucus hyperproduction. They remain a significant burden for patients, leading to increased healthcare costs and decreased quality of life. ETH47’s innovative mechanism of action aims to prevent those exacerbations at their source, potentially improving outcomes for millions of patients worldwide. 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 platforms 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 optimized formulation and nebulization 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 SOURCE: Ethris

MUNICH, Germany--( BUSINESS WIRE )-- Ethris GmbH , a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced promising topline data from the completed Phase 1 clinical trial of its lead mRNA therapeutic candidate, ETH47, in healthy volunteers. Designed to address the upstream trigger of asthma exacerbations, ETH47 encodes interferon lambda (IFNλ), a protein essential for viral immunity in the respiratory tract. These topline results provide the first clinical validation of Ethris’ pioneering targeted RNA therapeutic approach and its ability to induce a downstream cascade of antiviral interferon-stimulated genes locally following nasal administration. Thomas Langenickel, MD, Chief Medical Officer at Ethris, presented the results on January 30 th , 2025, at the mRNA-Based Therapeutics Summit Europe in Frankfurt, Germany. “These positive Phase 1 results reinforce the promise of ETH47 as a potentially safe and transformative treatment option for asthma patients, while also validating our SNIM ® and SNaP ® proprietary technology platforms as a viable delivery option for mRNA therapeutics to the respiratory tract,” said Dr. Thomas Langenickel, Chief Medical Officer at Ethris. “This significant milestone demonstrates the ability of our technology to deliver precisely designed mRNA candidates to the respiratory tract, facilitating production of the encoded protein and engagement with the intended target. With this strong foundation, we look forward to advancing ETH47 into Phase 2 trials in 2025 and remain committed to exploring its potential to transform care for patients with asthma and broader respiratory conditions.” The Phase 1 study assessed the safety, tolerability, and target engagement of ETH47 after nasal administration in 40 healthy participants. Key Results from the Phase 1 Study: 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. Dose-dependent target engagement: ETH47 exhibited a clear dose-dependent production of IFNλ in the nasal lining fluid exceeding predicted therapeutic levels. ETH47 administration also activated the mRNA expression of antiviral interferon-stimulated genes (ISGs) in nasal brush samples. These findings confirm ETH47’s pharmacodynamic activity and support its proposed mechanism of action. 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. This upcoming trial will focus on evaluating the ability of ETH47 to reduce lower respiratory symptoms in asthma patients following rhinovirus infection. About ETH47 ETH47 is Ethris’ first-in-class mRNA-based product candidate encoding interferon lambda (IFNλ) that was developed using the company’s Stabilized Non-Immunogenic mRNA (SNIM ® RNA) platform, and uniquely designed to be administered locally to the respiratory tract through inhalation or nasal spray using Ethris’ proprietary Stabilized NanoParticle (SNaP ® ) LNP platform. ETH47 is meant to induce a mucosal innate immune defense response at virus entry sites as well as inhibit viral replication. ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections, including virus-driven exacerbation of chronic respiratory diseases such as asthma. About Uncontrolled Asthma 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. Asthma exacerbations cause excessive inflammation and mucus hyperproduction. They remain a significant burden for patients, leading to increased healthcare costs and decreased quality of life. ETH47’s innovative mechanism of action aims to prevent those exacerbations at their source, potentially improving outcomes for millions of patients worldwide. 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 platforms 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 optimized formulation and nebulization 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