BlueWillow Biologics and Medigen Vaccine Biologics Corporation (MVC) have announced that a preclinical study of their BW-1019 intranasal COVID-19 booster demonstrated that giving the nasal vaccine after intramuscular vaccination induced neutralizing antibodies and protected against disease in a hamster model. According to the companies, no detectable virus was found … [Read more...] about Intranasal COVID-19 booster elicits mucosal immunity and protects against infection in preclinical studies
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Positive Phase 1 results for HRT’s naloxone nasal spray
Non-profit pharma company Harm Reduction Therapeutics (HRT) said that a Phase 1 clinical trial of its HRT001 naloxone nasal spray in healthy volunteers met its primary endpoint, demonstrating the bioequivalence of a 3.0 mg dose of HRT001 to a 0.4 mg dose of intramuscular naloxone at 2.5 and 5 minutes post dose. Funding for the study came from OxyContin manufacturer … [Read more...] about Positive Phase 1 results for HRT’s naloxone nasal spray
COPD Foundation partners with ENA Respiratory on development of pan-antiviral nasal spray
The COPD Foundation has partnered with ENA Respiratory for development of ENA's INNA-051 pegylated TLR2/6 agonist pan-antiviral nasal spray in patients with chronic lung disease, the company said. In June 2021, ENA Respiratory announced that it had raised A$32 million for development of INNA-051 and planned a Phase 1 trial. According to ENA, the Phase 1 study of … [Read more...] about COPD Foundation partners with ENA Respiratory on development of pan-antiviral nasal spray
TFF says in vitro studies demonstrate that its inhaled niclosamide may inhibit replication of the Omicron variant of SARS-CoV-2 better than currently available therapies
TFF Pharmaceuticals said that in vitro studies have demonstrated that the company's inhaled niclosamide candidate completely inhibits the Omicron variant of SARS-CoV-2 at a concentration of 1 μM, noting that both nirmatrelvir (Paxlovid) and molnupiravir have been shown to require concentrations of 2.5 μM or greater to completely inhibit Omicron. Enrollment in a … [Read more...] about TFF says in vitro studies demonstrate that its inhaled niclosamide may inhibit replication of the Omicron variant of SARS-CoV-2 better than currently available therapies
AstraZeneca partners with Honeywell on development of HFO-1234ze MDIs
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
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