AstraZeneca has announced a partnership with Honeywell for development of lower global warming potential MDIs using HFO-1234ze as a propellant. The company said that Breztri budesonide/ glycopyrronium/ formoterol fumarate is the first product it plans to convert to HFO-1234ze and that a Phase 1 trial of an HFO 1234ze formulation of budesonide/ glycopyrronium/ … [Read more...] about AstraZeneca partners with Honeywell on development of HFO-1234ze MDIs
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Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB
According to Armata Pharmaceuticals, the FDA has cleared the company's IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2 trial of AP-PA02 in NCFB patients this year. AP-PA02 is already in clinical development for the treatment of lung infections in cystic … [Read more...] about Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB
Virpax reports positive preclinical toxicology data for Envelta intranasal enkephalin
Virpax Pharmaceuticals said that preclinical studies of the company's Envelta (NES100) enkephalin nasal spray have not identified any toxicology issues in either rats or dogs. The company said that the results support further development of Envelta nasal spray for the treatment of pain, including cancer pain. In February 2021, Virpax announced that pre-clinical … [Read more...] about Virpax reports positive preclinical toxicology data for Envelta intranasal enkephalin
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