Savara Pharmaceuticals has announced that it is halting development of its AeroVanc vancomycin DPI after the Phase 3 AVAIL trial of AeroVanc for the treatment of MRSA lung infections in cystic fibrosis patients failed to meet its primary endpoint. The AVAIL trial, which was initiated in 2017, failed to show statistically significant improvement in lung function or a … [Read more...] about Savara halts development of AeroVanc, Apulmiq
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Regeneron partners with Penn to study feasibility of intranasal delivery of its antibody cocktail for COVID-19
Regeneron Pharmaceuticals is collaborating with researchers at the University of Pennsylvania (Penn) to study the feasibility of intranasal delivery of Regeneron’s casirivimab and imdevimab antibody cocktail for the prevention of COVID-19, the university said. The antibody cocktail, which recently received emergency use authorization from the FDA, is currently given … [Read more...] about Regeneron partners with Penn to study feasibility of intranasal delivery of its antibody cocktail for COVID-19
Codagenix completes dosing in Phase 1 trial of its intranasal RSV vaccine
Codagenix announced that it has completed dosing in a Phase 1 clinical trial of its intranasal CodaVax-RSV vaccine for the prevention of respiratory syncytial virus (RSV). According to Codagenix, its SAVE (Synthetic Attenuated Virus Engineering) codon deoptimization platform, "results in genetically stable vaccine strains that can engender robust immune responses and … [Read more...] about Codagenix completes dosing in Phase 1 trial of its intranasal RSV vaccine
Synairgen turns to Parexel for help with Phase 3 trial of inhaled interferon beta for COVID-19
Parexel announced that Synairgen has signed a collaboration agreement with Parexel Biotech for a Phase 3 trial of Synairgen's SNG001 nebulized interferon-beta-1a for the treatment of COVID-19. In July 2020, Synairgen announced positive results from a Phase 2 trial of SNG001 in COVID-19 patients hospitalized in the UK. The Phase 3 SG018 trial is expected to enroll 900 … [Read more...] about Synairgen turns to Parexel for help with Phase 3 trial of inhaled interferon beta for COVID-19
Marinomed announces planned Phase 4 trial of Carregelose nasal spray for COVID-19
Marinomed Biotech has announced plans for a Phase 4 trial of Carragelose iota-carrageenan nasal spray in healthcare professionals in contact with COVID-19 patients to study the ability of the nasal spray to reduce symptoms of viral respiratory infections, including SARS-CoV-2. The nasal spray is marketed as "Coldmaris Pro" in Austria, where the study will take … [Read more...] about Marinomed announces planned Phase 4 trial of Carregelose nasal spray for COVID-19
Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Milestone Pharmaceuticals has announced the initiation of the RAPID Phase 3 trial of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). A previous Phase 3 trial, NODE-301, failed to meet its primary endpoint. In July 2020, Milestone announced that it had reached an agreement with the FDA on the design of the RAPID study … [Read more...] about Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
Revelation Biosciences, which announced in October 2020 that the TGA had approved plans for a Phase 1 study of its REVTx‑99 intranasal phosphorylated hexaacylated disaccharide (PHAD), said that it has now initiated the trial. According to the company, 8 healthy volunteers have already received either REVTx-99 or placebo in the single ascending dose study, which is … [Read more...] about Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
Medigen Vaccine Biologics and BlueWillow Biologics have partnered for development of S-2P-NE-01, an intranasal vaccine against the SARS-CoV-2 virus, the companies said. According to the announcement, the vaccine will include BlueWillow's NanoVax nasal vaccine adjuvant and Medigen's S-2P spike protein; preclinical studies in mice have shown that the combination … [Read more...] about BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
TFF Pharmaceuticals and Felix Biotechnology have signed a non-binding letter of intent for a proposed agreement regarding development of an inhaled dry powder bacteriophage for the treatment of lung infections. Felix would need to successfully complete a Series A financing before entering into a definitive agreement, which would provide for Felix to make an upfront … [Read more...] about TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
TFF and Augmenta Bioworks partner on inhaled mAbs for COVID-19
TFF Pharmaceuticals and Augmenta Bioworks have announced a an agreement to collaborate on development of inhaled dry powder monoclonal antibodies (mAbs) for the treatment of COVID-19 based on Augmenta’s mAbs and TFF's thin film freezing particle technology. TFF will also have an option on two more Augmenta mAbs, which it could develop for the treatment of other … [Read more...] about TFF and Augmenta Bioworks partner on inhaled mAbs for COVID-19