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
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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
Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint
Gossamer Bio has announced that the TORREY Phase 2 study of its GB002 seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH) met its primary endpoint, demonstrating a statistically significant change in pulmonary vascular resistance (PVR) at Week 24. According to Gossamer, "Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and … [Read more...] about Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint
Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster
Intravacc announced that it has initiated a Phase 1 trial of Avacc 10 intranasal SARS-CoV-2 subunit vaccine, which the company is developing as a booster. Avacc 10 is based on the same outer membrane vesicles (OMV) technology as the company's intranasal vaccines against gonorrhea and betacoronavirus vaccines. Intravacc had announced in June 2020 that it would develop … [Read more...] about Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster
Vistagen announces planned Phase 1 trial of new formulation of PH10 nasal spray
After receiving a "Study May Proceed" letter from the FDA, Vistagen has announced plans for a Phase 1 trial of a re-formulated version of PH10 pherin nasal spray. The new Phase 1 study is expected to begin in early 2023 as part of plans to develop the nasal spray for the treatment of major depressive disorder. A previous Phase 2a trial of PH10 for that indication … [Read more...] about Vistagen announces planned Phase 1 trial of new formulation of PH10 nasal spray