Ampio Pharmaceuticals has announced that the final results from the AP-014 Phase 1 trial of inhaled Ampion in COVID-19 patients demonstrated a greater reduction in all-cause mortality than was seen in the preliminary results. In March 2021, Ampio reported that preliminary data from the trial showed a 62% reduction in all-cause mortality. After all patients completed … [Read more...] about Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Medical
Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
Covis Pharma said that a Phase 3 trial of Alvesco ciclesonide MDI for the treatment of COVID-19 in 400 patients who have not been hospitalized failed to meet its primary endpoint, which was freedom from COVID-19 symptoms for 24 continuous hours by Day 30. The difference in time to alleviation of patients' COVID-19 symptoms was 70.6% for the ciclesonide MDI and 63.5% … [Read more...] about Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study
Virpax Pharmaceuticals announced that a study of its MMS019 powder "masking spray" in mice demonstrated "a marked inhibition of viral replication in the mouse nasal passages" for mice infected with SARS-CoV-2 and then given MMS019 intranasally for 6 days. Virpax licensed MMS019 from Nanomerics in August 2020 and is developing the formulation for the prevention of … [Read more...] about Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study
Nasus Pharma says BE study demonstrates its intranasal dry powder naloxone is absorbed faster than Narcan nasal spray
Nasus Pharma said that a bioequivalence study of its FMXIN001 dry powder intranasal naloxone demonstrated that FMXIN001 was absorbed significantly faster than Emergent BioSolutions' Narcan naloxone nasal spray, with an AUC 163% of the Narcan AUC after 4 minutes, and continued to demonstrate higher levels of naloxone in the blood through the first hour post dosing. The … [Read more...] about Nasus Pharma says BE study demonstrates its intranasal dry powder naloxone is absorbed faster than Narcan nasal spray
Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
Johnson & Johnson has decided not to exercise an option acquired in a 2020 agreement with Pulmatrix for development and commercialization of Pulmatrix's portfolio of inhaled narrow spectrum kinase inhibitors (NSKIs), including PUR1800. J&J's Lung Cancer Initiative had been interested in developing the dry powder formulation for lung cancer … [Read more...] about Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
AIM ImmunoTech has announced that it will definitely advance an intranasal formulation of its Ampligen rintatolimod into a Phase 2 trial after the initial dose tested in a Phase 1 study showed no safety problems. The company announced initiation of the Phase 1 study, which is set to enroll 40 healthy subjects, in March 2021. The Phase 1 study began with a 75 μg dose … [Read more...] about AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate
Intravacc has announced that a pre-clinical study of its intranasal outer membrane vesicle (OMV)-based recombinant spike protein (rSP) vaccine candidate against SARS-CoV-2 nose spray vaccine in hamsters and mice demonstrated complete protection. The company announced in June 2020 that it had partnered with Wageningen Bioveterinary Research and Utrecht University to … [Read more...] about Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate
Phase 1 study of Union Therapeutics’ inhaled and intranasal niclosamide meets all endpoints
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
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