BiondVax Pharmaceuticals announced that 6 days post infection, hamsters treated with the company's NanoAb inhaled nanosized antibodies had levels of SARS-COV-2 in their lungs reduced to levels 30 times lower than hamsters that got an inhaled placebo. BiondVax licensed the NanoAb technology from the Max Planck Institute in March 2022 and announced development plans for … [Read more...] about BiondVax reports positive preclinical results for its NanoAb inhaled nanosized antibodies against COVID-19
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Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE
Pulmatrix has announced that a Phase 1 PK trial of its PUR3100 dihydroergotamine (DHE) DPI in healthy volunteers demonstrated that all 3 doses tested produced peak exposures in the desired range with a Tmax of 5 minutes post-dose. Subjects receiving PUR3100 also experienced less nausea than those getting IV DHE. Pulmatrix, which is developing PUR3100 for the treatment … [Read more...] about Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE
Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19
According to the Centenary Institute, the New South Wales COVID-19 Vaccine Acceleration Research Grants Program has awarded a grant worth AU$995,867 to researchers at the Centenary Institute and the University of Sydney to support development of an intranasal vaccine against COVID-19. Sydney-based Ab Initio Pharma, which was recently granted a license to manufacture … [Read more...] about Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19
Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients
Armata Pharmaceuticals announced that it has completed the Phase 1b/2a SWARM-P.a. trial of its AP-PA02 inhaled phage cocktail in cystic fibrosis patients who have chronic P. aeruginosa lung infections. The SWARM-P.a. study was initiated in 2020 with support from the Cystic Fibrosis Foundation. In October 2021, the Cystic Fibrosis Foundation and Innoviva made equity … [Read more...] about Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients
Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate
Oragenics said that results from a toxicology study of its NT-CoV2-1 intranasal vaccine conducted in rabbits "confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study." In June 2022, the company published data from preclinical studies of NT-CoV2-1 in mice and hamsters … [Read more...] about Oragenics says no indication of toxicity for its NT-CoV2-1 intranasal vaccine candidate
Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Biotech Orgenesis and nasal delivery specialist Kurve Therapeutics have announced results from a preclinical study of an intranasal "cell-based oncolytic virus bearing product" in a mouse model of glioblastoma. Orgenesis says that it manufactured the product on behalf of "a premier cell therapy development company." According to the companies, delivery of the product … [Read more...] about Orgenesis and Kurve say preclinical study demonstrated that intranasal cell therapy reduced tumors by 50% in a mouse model of glioblastoma
Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
According to Beckley Psytech, the company has initiated a Phase 2a study of its BPL-003 intranasal dry powder 5-MeO-DMT for the treatment of moderate-to-severe treatment-resistant depression. Beckley Psytech recently reported results from a Phase 1 study showing a dose proportional PK profile for BPL-003; that study also found that any consciousness-altering effects … [Read more...] about Beckley Psytech initiates Phase 2a study of BPL-003 intranasal dry powder 5-MeO-DMT for treatment-resistant depression
SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF
Israel-based SpliSense said that it has initiated a Phase 1/2 trial of its SPL84 inhaled anti sense oligonucleotide for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has been granted Orphan Drug designation from both the EMA and the FDA. The company said that the SAD portion of the trial will evaluate SPL84 in healthy … [Read more...] about SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF
Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe … [Read more...] about Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine
FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Vertex Pharmaceuticals said that it plans to initiate a Phase 1 SAD trial of its VX-522 inhaled mRNA therapy after the FDA cleared the company's IND. VX-522 contains lipid nanoparticle-encapsulated mRNA that is designed to treat cystic fibrosis in patients who do not produce cystic fibrosis transmembrane conductance regulator (CFTR) and are therefore not helped by a … [Read more...] about FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF