Medical

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

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

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

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 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

Polyphor and EnBiotix have announced the initiation of Phase 1 trial of nebulized murepavadin in healthy volunteers; Polyphor had announced approval of a Phase 1 study by the MHRA in December 2020. The murepavadin inhalation solution, which is delivered via the PARI eFlow nebulizer, is in development for the treatment of P. aeruginosa lung infections in cystic … [Read more...] about Phase 1 trial of inhaled murepavadin gets underway

Aerovate Therapeutics has initiated a Phase 2b/3 trial of its AV-101 imatinib DPI for the treatment of pulmonary arterial hypertension (PAH), the company said. The IMPAHCT trial is expected to enroll 462 PAH patients; the Phase 2b portion of the trial will evaluate three doses of AV-101 versus placebo to select a dose for the Phase 3 portion. Topline results from the … [Read more...] about Aerovate initiates Phase 2b/3 trial of AV-101 inhaled imatinib for PAH

McMaster University announced that Health Canada has cleared a Phase 1 trial of two inhaled adenovirus vector vaccines against SARS-CoV-2, and the study is set to begin shortly. The trial is expected to enroll at least 30 healthy volunteers who have already received two doses of an mRNA vaccine. Each of the participants will receive a single dose of one of the … [Read more...] about McMaster University announces Phase 1 trial of two inhaled COVID-19 vaccines