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
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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
Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Belgium-based Hyloris Pharmaceuticals announced that it has added an intranasal TRPV1 agonist (HY-083) for the treatment of idiopathic rhinitis to its pipeline. TRPV1 (transient receptor potential cation channel subfamily V member 1) is overexpressed in the nasal mucosa in idiopathic rhinitis. According to the company, "Hyloris’ treatment approach is to activate and … [Read more...] about Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Aerovate Therapeutics publishes data from Phase 1 trial of AV-101 imatinib DPI
Aerovate Therapeutics has published data from a Phase 1 study of its AV-101 dry powder imatinib showing that the inhaled formulation resulted in significantly lower systemic exposure compared to oral imatinib. The company announced the initiation of the IMPAHCT trial Phase 2b/3 of AV-101 in patients with pulmonary arterial hypertension (PAH) in December 2021. The … [Read more...] about Aerovate Therapeutics publishes data from Phase 1 trial of AV-101 imatinib DPI
Beckley Psytech reports results from Phase 1 study of BPL-003 intranasal dry powder 5-MeO-DMT
Beckley Psytech has announced that a Phase 1 SAD study of its BPL-003 intranasal dry powder synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) found that the PK profile was dose proportional and consciousness altering effects of the drug were short-lived. The study enrolled 44 patients aged 25-55 who received single doses of BPL-003 up to 12 mg or placebo. The … [Read more...] about Beckley Psytech reports results from Phase 1 study of BPL-003 intranasal dry powder 5-MeO-DMT
Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Following the failure of the Phase 3 SUMMIT trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine to meet the study's primary endpoints, Satsuma Pharmaceuticals says that the company will not invest in commercialization of the product. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its … [Read more...] about Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Blue Lake announces interim data from Phase 1 trial of BLB201 intranasal vaccine against RSV
CyanVac subsidiary Blue Lake Biotechnology has presented interim data from a Phase 1 trial of its BLB201 intranasal vaccine against respiratory syncytial virus (RSV) that demonstrate an increase in serum antibody responses from baseline in just under two thirds of subjects aged 18-59, with viral shedding observed in 21% of this age cohort following vaccination. The … [Read more...] about Blue Lake announces interim data from Phase 1 trial of BLB201 intranasal vaccine against RSV
Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
Meissa Vaccines is presenting Phase 1c data from a study of its MV-012-968 intranasal live attenuated RSV vaccine candidate in 66 children aged 6-36 months demonstrating that the highest dose of the vaccine evaluated induced an immune response in 89% of RSV-naïve subjects, with a serum neutralizing antibody response induced in 78% of the subjects. According to … [Read more...] about Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device