According to Union Therapeutics, a Phase 1 study of its UNI911 niclosamide solution met its primary endpoint, demonstrating "a strong safety profile" for both inhaled and intranasal delivery; the company said that the PK results were also encouraging. Union is developing the formulation for the prevention of COVID-19 (UNI91103) and for the treatment of COVID-19 … [Read more...] about Phase 1 study of Union Therapeutics’ inhaled and intranasal niclosamide meets all endpoints
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Positive Phase 1 results for Neupharma’s inhaled teicoplanin in CF patients
Neupharma, which is developing inhaled teicoplanin for the treatment of MRSA lung infections in CF patients in partnership with Rare Partners, has announced that a Phase 1 PK study of the formulation in cystic fibrosis patients demonstrated that the concentration of teicoplanin measured in the sputum 24 hours post-dose was dose dependent and exceeded the minimum … [Read more...] about Positive Phase 1 results for Neupharma’s inhaled teicoplanin in CF patients
Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics' UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the company said. Union announced the initiation of the PROTECT-V trial in February 2021. Union co-founder Morten Sommer commented, "We … [Read more...] about Study of Union’s intranasal niclosamide for the treatment of COVID-19 in kidney patients gets UPH designation
Oxford announces Phase 1 trial of intranasal version of its COVID-19 vaccine
The University of Oxford has announced that it is recruiting subjects for a Phase I trial of a nasal spray version of its COVID-19 vaccine. The trial is expected to enroll 30 healthy adults aged 18–40 who will receive the ChAdOx1 nCoV-19 vaccine intranasally, and researchers from the university's Jenner Institute will follow the subjects for four months post dosing. … [Read more...] about Oxford announces Phase 1 trial of intranasal version of its COVID-19 vaccine
Marinomed initiates trial of Inhaleen Carragelose inhalation solution for the treatment of COVID-19
According to Marinomed Biotech, a clinical trial of the company's Inhaleen Carragelose iota-carageenan inhalation solution for the treatment of moderate COVID-19 is now underway. In April 2020, Marinomed announced that it had received funding for development of a Carragelose inhalation solution for the treatment of COVID-19 pneumonia. The trial of the inhalation … [Read more...] about Marinomed initiates trial of Inhaleen Carragelose inhalation solution for the treatment of COVID-19
Summit Biosciences to produce multidose nasal spray version of Altimmune’s AdCOVID vaccine
Altimmune announced that it has signed a manufacturing agreement with Summit Biosciences for a multidose version of Altimmune's AdCOVID intranasal vaccine against COVID-19. The announcement comes shortly after Altimmune announced an agreement with Lonza for manufacturing of the single dose version of the vaccine in a dedicated suite at Lonza's Texas facility. A Phase … [Read more...] about Summit Biosciences to produce multidose nasal spray version of Altimmune’s AdCOVID vaccine
Phase 2b study of Galecto’s galectin-3 DPI for IPF to discontinue higher dose arm
Galecto has announced that the company's Phase 2b GALACTIC-1 study of GB0139 (formerly TD139) galectin-3 inhibitor DPI for the treatment of idiopathic pulmonary fibrosis (IPF) will discontinue the higher dose (10 mg) arm and will limit enrollment in the lower dose (3 mg) arm to patients who are not taking nintedanib or pirfenidone. The company said that it is making … [Read more...] about Phase 2b study of Galecto’s galectin-3 DPI for IPF to discontinue higher dose arm
FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Meissa Vaccines announced that the FDA has cleared the company's IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy … [Read more...] about FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Positive Phase 1 results for inhaled Ampion for COVID-19
Ampio Pharmaceuticals said that preliminary results from its AP-014 Phase 1 clinical trial of inhaled Ampion for the treatment of COVID-19 demonstrate a significant reduction in all-cause mortality and shorter hospital stays for patients receiving Ampion compared to standard of care alone. Ampio initiated the Phase 1 trial in October 2020. Based on the initial … [Read more...] about Positive Phase 1 results for inhaled Ampion for COVID-19
SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19
Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose and by more than 99% within 72 hours. In addition, clearance of the SARS-CoV-2 virus was 16 times faster for patients using NONS than for those given a placebo. Based … [Read more...] about SaNOtize to apply for emergency use authorization in UK and Canada for its NO nasal spray for COVID-19