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Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19

Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had partnered with Inhalon Biopharma on development of an inhaled formulation of regdanvimab for the treatment of COVID-19. The proposed Phase 3 trial, … [Read more...] about Celltrion submits IND for Phase 3 study of inhaled antibody cocktail for COVID-19

Opiant initiates Phase 2 trial of OPNT002 naloxone nasal spray for the treatment of alcoholism

Opiant Pharmaceuticals said that it has initiated a Phase 2 trial of its OPNT002 intranasal naltrexone for the treatment of alcohol use disorder that is expected to enroll approximately 300 patients, with results expected in 2023. The study will evaluate the efficacy of OPNT002 by measuring improvement in WHO drinking risk level. OPNT002 is formulated with … [Read more...] about Opiant initiates Phase 2 trial of OPNT002 naloxone nasal spray for the treatment of alcoholism

CFF awards grant to Feldan Therapeutics for development of pulmonary delivery technology for CF

The Cystic Fibrosis Foundation has awarded funding to Feldan Therapeutics for development of the company's Feldan Shuttle technology for pulmonary delivery of drugs to treat cystic fibrosis. Neither the company nor the CFF disclosed the amount of the award, which was made under the CFF's Path to a Cure initiative. Social media posts from the CFF said that the purpose … [Read more...] about CFF awards grant to Feldan Therapeutics for development of pulmonary delivery technology for CF

Theravance Biopharma initiates Phase 4 trial of Yupelri inhalation solution

Theravance Biopharma has announced the initiation of a Phase 4 study of Yupelri revefenacin inhalation solution, which was approved by the FDA in 2018 for the treatment of COPD. The PIFR-2 study, which is expected to enroll 366 patients with severe to very severe COPD, will compare Yupelri to Spiriva HandiHaler tiotropium DPI over 12 weeks. Topline results are … [Read more...] about Theravance Biopharma initiates Phase 4 trial of Yupelri inhalation solution

I-SPY COVID trial finds no clinical benefit for use of Pulmozyme in severe COVID-19

According to Quantum Leap Healthcare Collaborative (QLHC), a sponsor of the I-SPY COVID trial, interim analysis of data from a study of Genentech's Pulmozyme dornase alfa inhalation solution for the treatment of severe COVID-19 found that Pulmozyme therapy "is unlikely to achieve statistically significant improvement in efficacy," and the Pulmozyme arm of the trial … [Read more...] about I-SPY COVID trial finds no clinical benefit for use of Pulmozyme in severe COVID-19

Intravacc and Leiden University Medical Center announce planned Phase 1/2 study of Nanovac intranasal vaccine against coronaviruses

Intranasal vaccine developer Intravacc and Leiden University Medical Center (LUMC) have announced a planned Phase 1/2 trial of LUMC's Nanovac intranasal vaccine against coronaviruses, including SARS, MERS, and SARS-CoV-2. The trial is expected to begin by the end of 2022 with initial results available in the first half of 2023. In September 2021, Intravacc … [Read more...] about Intravacc and Leiden University Medical Center announce planned Phase 1/2 study of Nanovac intranasal vaccine against coronaviruses

Pieris announces progress in clinical development of PRS-060/AZD1402 DPI for the treatment of moderate-to-severe asthma

Pieris Pharmaceuticals said that part 1a of a clinical trial of PRS-060/AZD1402, a dry powder IL-4 receptor alpha inhibitor which the company is developing with AstraZeneca for the treatment of moderate-to-severe asthma, has been completed. Pieris said that it now expects AstraZeneca to start enrolling patients with asthma that is insufficiently controlled by medium … [Read more...] about Pieris announces progress in clinical development of PRS-060/AZD1402 DPI for the treatment of moderate-to-severe asthma

Australian researchers get $4.2 million grant for trial of intranasal heparin for COVID-19

According to Australian healthcare system Northern Health, the government of the state of Victoria will provide a $4.2 million grant to the University of Melbourne and Monash University to fund a clinical trial of intranasal heparin for the prevention and treatment of COVID-19. The Intra Nasal HEpaRin Trial (INHERIT) trial, which will be run by Northern Health, is … [Read more...] about Australian researchers get $4.2 million grant for trial of intranasal heparin for COVID-19

Aridis says its inhaled mAb candidate can neutralize all SARS-CoV-2 variants, including Omicron, plus additional coronaviruses

Aridis Pharmaceuticals said that in vitro testing has demonstrated that its AR-701 monoclonal antibody (mAb) cocktail AR-701 has the ability to neutralize all SARS-CoV-2 variants, including Omicron, as well as the coronaviruses that cause SARS, MERS, and the common cold. The company also said that AR-701 is expected to provide protection against those viruses for 6 … [Read more...] about Aridis says its inhaled mAb candidate can neutralize all SARS-CoV-2 variants, including Omicron, plus additional coronaviruses