Parainfluenzae virus infection

Data published in Advanced Science and Bioengineering and Translational Medicine evaluates the efficacy of intranasal delivery of antibodies to RSV-infected neonatal lambs and SARS-CoV-2 infected hamsters DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections. The data, published in Advanced Science and in Bioengineering and Translational Medicine, underscore the potential therapeutic benefits from leveraging inhaled delivery of antibodies to treat a range of acute respiratory infections, including not only RSV and SARS-CoV-2 variants, but also influenza, human metapneumovirus (hMPV), and parainfluenza (PIV). “Inhalon’s approach rethinks the use of antibodies for the treatment of acute respiratory infections by delivering antibodies directly to the site of the infection,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “Our studies in Advanced Science and in Bioengineering and Translational Medicine demonstrate the exceptional effectiveness of our inhaled antibody platform, which offers the potential to treat a wide array of acute respiratory infections. With the results from these studies, we are advancing candidates against RSV and all variants of SARS-CoV-2 into the clinic.” There remains a high unmet need for new outpatient treatments for acute respiratory infections despite the availability of vaccines for influenza, RSV, and COVID-19. The U.S. Centers for Disease Control and Prevention estimates that 360,000 people were hospitalized with influenza during the 2022-2023 season.1 RSV is responsible for 58,000-80,000 hospitalizations in children ages five and under, as well as 60,000-160,000 hospitalizations in older adults every year.2 While COVID-19 is harder to estimate on an annual basis, there are currently more than 15,000 hospitalizations per week in the U.S.3 The preclinical data published in Advanced Science evaluates the efficacy of treating an established RSV infection with inhaled antibodies. In the study, RSV-infected neonatal lambs received daily nebulized delivery of Mota-MT, Inhalon’s muco-trapping antibody against RSV. Treatment was delayed until three days post infection when the virus was at peak levels in the lung. Following three days of once-per-day nebulized treatment, Mota-MT reduced viral load by 10,000-fold to 100,000-fold compared to the placebo group, with most animals exhibiting no detectable virus in the respiratory tract. This directly correlated with reduced inflammation, bronchiolitis, neutrophil infiltration, and airway remodeling; the lungs of many animals treated with Mota-MT appeared no different than uninfected animals, despite the very late initiation and short duration of treatment. Inhalon has completed IND-enabling studies with a derivative of Mota-MT and is planning to start a Phase 1 study later this year. The study published in Bioengineering and Translational Medicine assesses the efficacy of a muco-trapping ACE2-(G4S)6-FC decoy that binds and neutralizes SARS-CoV-2, without risk of viral escape. The molecule has shown picomolar potencies against all strains of SARS-CoV-2 tested, including Omicron variants. In the study, hamsters that received intranasal dosing as late as two days post infection saw at least a ten-fold viral load decrease by day four. With the support of the USAMRDC, Inhalon has begun preclinical activities and manufacturing to advance this candidate into the clinic in 2025. About Inhalon Biopharma Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC. The muco-trapping mAb technology, Mota-MT and the ACE2-(G4S)6-FC decoy were originally developed by Prof. Sam Lai at the University of North Carolina (UNC) - Chapel Hill, and licensed exclusively by Inhalon. Centers for Disease Control and Prevention, “Burden of Flu.” Available: . Centers for Disease Control and Prevention, “Respiratory Syncytial Virtus Infection (RSV).” Available: . Centers for Disease Control and Prevention, “COVID Data Tracker.” Available: .

SEATTLE , March 23, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of targeted therapies for life-threatening pulmonary diseases, today reported that results from the Phase 1b ATLAS study were published online in Thorax, an official journal of the British Thoracic Society. The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks. Efficacy and safety results at weeks 24 and 48 are also reported. “While oral pirfenidone has the potential to improve lung function by reducing fibrosis, its utility is limited by its poor tolerability profile,” explained Lyn Baranowski, Avalyn’s CEO. “Although the ATLAS study's primary endpoint was safety, secondary measures of efficacy showed a trend towards disease stabilization in participants with IPF who administered high-dose AP01. Based on this data, we believe AP01 has the potential to meet or exceed the efficacy of oral pirfenidone without the systemic toxicities that limit its adoption. We are eager to explore this hypothesis in a larger, controlled efficacy trial that we plan to begin later this year.” At baseline, mean forced vital capacity (FVC), a measure of lung capacity, was 2.5 L for ATLAS study participants in the 50 mg QD arm and 2.6 L in the 100 mg BID arm. Most participants in the 100 mg BID group experienced stabilization of FVC with a mean change of 0.6% at week 24 and -0.4% at week 48. These results suggest inhaled pirfenidone is successfully delivered to the target tissue with beneficial effect. Supporting these observations, FVC changes in the 100 mg BID group correlated with changes in quantitative lung fibrosis scores, as measured by high-resolution computed tomography (HRCT). While oral pirfenidone has the potential to improve lung function by reducing fibrosis, its utility is limited by a poor tolerability pro incidence of adverse events including elevated liver enzymes, diarrhea, vomiting and nausea. “The tolerability pro saw with AP01 in this study is really important because we see so many patients who may try to take the oral antifibrotics but eventually stop as the side-effects become increasingly difficult to bear as their disease progresses, and others who cannot tolerate them for even a short time,” added Alex West, Interstitial Lung Disease Lead at Guy's and St Thomas' Hospital, London and an investigator in the ATLAS study. “AP01 has the potential to keep patients on effective therapy longer, which might translate into increased life expectancy and quality of life.” The doses of AP01 studied (50 mg QD or 100 mg BID) were well tolerated with no adverse effects on respiratory rate, spirometry, or oxygenation during or following administration. 48-week treatment-emergent adverse events (AEs) reported for at least 10% of patients in either dose group included cough, rash, dyspnea, nausea, IPF, fatigue, lower respiratory tract infection and upper respiratory tract infection. Except for a Grade 3 parainfluenza virus infection, all other treatment-related events were mild or moderate. One treatment-related liver enzyme increase occurred but resolved after dose interruption. About the ATLAS Study The open-label ATLAS study enrolled 91 adults with IPF who were intolerant of or ineligible for oral pirfenidone or nintedanib. Participants were randomized to one of two treatment arms: 50 mg AP01 once daily (QD) or 100 mg twice daily (BID) delivered with the eFlow Nebulizer System (eFlow® nebulizer; PARI GmbH, Germany). The ATLAS study assessed the safety, tolerability and efficacy of two AP01 doses in patients with IPF. Of the 91 participants who enrolled, 77 (85%) completed 24 weeks of treatment. Following review of week 24 data, the DSMB recommended all participants transition to the higher dose of AP01. Dosing continued in the ATLAS study through week 72. Five participants receiving low-dose AP01 transitioned to the higher dose before or during their week 48 visit; an additional 16 transitioned by week 72. All participants who reached week 72 were eligible to participate in an open-label extension study. Of the 54 who reached week 72, 41 (76%) continued into the open-label extension. To date, 100 individuals with IPF and other forms of pulmonary fibrosis, including progressive pulmonary fibrosis, are enrolled in the open-label extension, eight of whom have been on study medication for over three years. Findings from the open-label extension study will be presented at upcoming medical meetings. About AP01 (Pirfenidone Solution for Inhalation) Pirfenidone is a small molecule shown to inhibit fibroblast differentiation and extracellular matrix (ECM) production. AP01 is an inhaled aerosol formulation of pirfenidone that is delivered using the eFlow® nebulizer, a high efficiency vibrating membrane nebulizer similar in design and operation to PARI’s 510(k) cleared/FDA-approved eFlow-based nebulizers marketed with other products for other disease indications. This administration method allows a smaller pirfenidone dose to be delivered as a soft mist directly to the lung, maximizing pirfenidone's effect on diseased lung tissue while sparing tissue outside of the lungs from the debilitating toxicities associated with oral delivery. Avalyn is planning to advance AP01 (100 mg BID) into the next phase of the clinical program in 2023. About Avalyn Pharma Avalyn is a biopharmaceutical company developing targeted therapeutics for the treatment of rare respiratory diseases including IPF and other interstitial lung diseases (ILD). ILDs are characterized by scarring, a decline in lung function, reduced exercise capacity and quality of life, and are associated with increased mortality. Currently approved therapeutic options slow ILD progression but are associated with significant toxicities, which restrict their use and dosing. Avalyn is developing a pipeline of inhaled therapeutics designed to reduce systemic exposure and deliver medication to the site of disease. AP01, Avalyn’s lead candidate, is an inhaled formulation of pirfenidone optimized for delivery via inhalation. In a recent clinical study of two doses assessed in 91 individuals with IPF, AP01 demonstrated the potential to improve efficacy and safety over existing therapy. More information can be found at . For general inquiries: Marc Schneebaum Chief Financial Officer, Avalyn Pharma, Inc mschneebaum@avalynpharma.com Media: Aline Sherwood Scienta Communications asherwood@scientapr.com

Dublin, July 06, 2021 (GLOBE NEWSWIRE) -- The "Respiratory Virus Infection Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 - 2030" report has been added to ResearchAndMarkets.com's offering. The publisher's report on the global respiratory virus infection drugs market studies past as well as current growth trends and opportunities to gain valuable insights of these indicators of the market during the forecast period from 2020 to 2030. The report provides revenue of the global respiratory virus infection drugs market for the period 2018-2030, considering 2019 as the base year and 2030 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global respiratory virus infection drugs market during the forecast period.The report has been prepared after primary and secondary researches. Primary research involved bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Secondary research involved referring to key players' product literature, annual reports, press releases, and relevant documents to understand the global respiratory virus infection drugs market.Secondary research also included Internet sources, statistical data from government agencies, websites, company presentations, sales data, and trade associations. Analysts employed a combination of top-down and bottom-up approaches to study various phenomenon in the global respiratory virus infection drugs market.The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Furthermore, the report sheds light on the changing competitive dynamics in the global respiratory virus infection drugs market. These indices serve as valuable tools for existing market players as well as for entities interested in entering the global respiratory virus infection drugs market.The report delves into the competitive landscape of the global respiratory virus infection drugs market. Key players operating in the global respiratory virus infection drugs market have been identified, and each one of these has been profiled for distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players in the global respiratory virus infection drugs market that have been profiled in this report.Key Questions Answered in Respiratory Virus Infection Drugs Market Report Key Topics Covered: 1. Preface2. Assumptions and Research Methodology3. Executive Summary: Global Respiratory Virus Infection Drugs Market4. Market Overview4.1. Introduction4.1.1. Drug Type Definition4.1.2. Industry Evolution / Developments4.2. Overview4.3. Market Dynamics4.3.1. Drivers4.3.2. Restraints4.3.3. Opportunities4.4. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, 2018-20305. Key Insights5.1. Healthcare Industry Overview5.2. Pipeline Analysis (asthma and COPD)5.3. Regulatory Scenario 5.4. Disease Prevalence Rate in Key Countries5.5. Key Market Events5.6. COVID-19 Pandemic Impact on Industry6. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Drug Type6.1. Introduction & Definition6.2. Key Findings / Developments6.3. Market Value Forecast, by Drug Type, 2018-20306.3.1. Antibiotics6.3.2. Non-steroidal Anti-inflammatory Drugs (NSAIDS)6.3.3. Cough Suppressants6.3.4. Nasal Decongestants6.3.5. Others6.4. Market Attractiveness Analysis, by Drug Type7. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Infection Type7.1. Introduction & Definition7.2. Key Findings / Developments7.3. Market Value Forecast, by Infection Type, 2018-20307.3.1. Respiratory Syncytial Virus (RSV) Infection7.3.2. Influenza Virus Infection7.3.3. Parainfluenza Virus Infection7.3.4. Adenovirus Infection7.3.5. Rhinovirus Infection7.3.6. Others7.4. Market Attractiveness Analysis, by Infection Type8. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Route of Administration8.1. Introduction & Definition8.2. Key Findings / Developments8.3. Market Value Forecast, by Route of Administration, 2018-20308.3.1. Oral8.3.2. Parenteral8.4. Market Attractiveness Analysis, by Route of Administration9. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Mode of Purchase9.1. Introduction & Definition9.2. Key Findings / Developments9.3. Market Value Forecast, by Mode of Purchase, 2018-20309.3.1. Prescription-based Drugs9.3.2. Over-the-Counter Drugs9.4. Market Attractiveness Analysis, by Mode of Purchase10. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Distribution Channel10.1. Introduction & Definition10.2. Key Findings / Developments10.3. Market Value Forecast, by Distribution Channel, 2018-203010.3.1. Hospital Pharmacies10.3.2. Drug Stores10.3.3. Retail Pharmacies10.3.4. Clinics10.3.5. Others10.4. Market Attractiveness Analysis, by Distribution Channel11. Global Respiratory Virus Infection Drugs Market Analysis and Forecast, by Region11.1. Key Findings11.2. Market Value Forecast, by Region11.2.1. North America 11.2.2. Europe 11.2.3. Asia Pacific 11.2.4. Latin America 11.2.5. Middle East & Africa 11.3. Market Attractiveness Analysis, by Country/Region 12. North America Respiratory Virus Infection Drugs Market Analysis and Forecast 13. Europe Respiratory Virus Infection Drugs Market Analysis and Forecast 14. Asia Pacific Respiratory Virus Infection Drugs Market Analysis and Forecast 15. Latin America Respiratory Virus Infection Drugs Market Analysis and Forecast 16. Middle East & Africa Respiratory Virus Infection Drugs Market Analysis and Forecast 17. Competition Landscape17.1. Market Player - Competition Matrix (by tier and size of companies)17.2. Market Share Analysis/Ranking, by Company, 201917.3. Company Profiles17.3.1. GlaxoSmithKline plc 17.3.1.1. Company Overview17.3.1.2. Company Financials17.3.1.3. Growth Strategies17.3.1.4. SWOT Analysis17.3.2. Merck & Co., Inc. 17.3.2.1. Company Overview17.3.2.2. Company Financials17.3.2.3. Growth Strategies17.3.2.4. SWOT Analysis17.3.3. AstraZeneca17.3.3.1. Company Overview17.3.3.2. Company Financials17.3.3.3. Growth Strategies17.3.3.4. SWOT Analysis17.3.4. Boehringer Ingelheim International GmbH 17.3.4.1. Company Overview17.3.4.2. Company Financials17.3.4.3. Growth Strategies17.3.4.4. SWOT Analysis17.3.5. F. Hoffmann-La Roche Ltd. 17.3.5.1. Company Overview17.3.5.2. Company Financials17.3.5.3. Growth Strategies17.3.5.4. SWOT Analysis17.3.6. Teva Pharmaceutical Industries Ltd. 17.3.6.1. Company Overview17.3.6.2. Company Financials17.3.6.3. Growth Strategies17.3.6.4. SWOT Analysis17.3.7. Sanofi17.3.7.1. Company Overview17.3.7.2. Company Financials17.3.7.3. Growth Strategies17.3.7.4. SWOT Analysis17.3.8. Cipla, Inc. 17.3.8.1. Company Overview17.3.8.2. Company Financials17.3.8.3. Growth Strategies17.3.8.4. SWOT Analysis17.3.9. CHIESI Farmaceutici S.p.A. 17.3.9.1. Company Overview17.3.9.2. Company Financials17.3.9.3. Growth Strategies17.3.9.4. SWOT Analysis17.3.10. Orion Corporation17.3.10.1. Company Overview17.3.10.2. Growth Strategies17.3.10.3. SWOT AnalysisFor more information about this report visit