TFF Pharmaceuticals announced that a Phase 1 SAD/MAD study of its dry powder niclosamide found that inhalation of the formulation was well tolerated at all doses evaluated and that data from the study suggest moving into a Phase 2 study with a twice daily 6 mg dose. The company, which recently said that the dry powder niclosamide completely inhibited the Omicron … [Read more...] about Positive Phase 1 results for TFF Pharmaceuticals’ dry powder niclosamide
Medical
Intranasal minibinder proteins effective against SARS-CoV-2 in preclinical studies
Researchers from Northwestern University, the University of Washington, and Washington University at St. Louis have published data demonstrating that select miniproteins neutralized SARS-CoV-2 better than mAbs currently in use for the treatment of COVID-19. The multivalent minibinder demonstrated potent activity against all variants of the virus tested, including … [Read more...] about Intranasal minibinder proteins effective against SARS-CoV-2 in preclinical studies
FDA allows additional MS patients in intranasal Foralumab expanded access program
Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana's intranasal Foralumab under an Intermediate-Size Patient Population Expanded Access IND. The agency evaluated data from treatment of two … [Read more...] about FDA allows additional MS patients in intranasal Foralumab expanded access program
Respira initiates Phase 2b trial of RT234 inhaled vardenafil for PAH
Respira Therapeutics has announced the initiation of a Phase 2b trial of its RT234 dry powder vardenafil in patients with pulmonary arterial hypertension (PAH). The open label study will include two cohorts, with the first receiving a single 0.5 mg dose of RT234 via the Axial Oscillating Sphere inhaler and the second getting a 1 mg dose (2 x 0.5 mg). United … [Read more...] about Respira initiates Phase 2b trial of RT234 inhaled vardenafil for PAH
Phase 2b challenge study of intranasal PHAD for the prevention of H3N2 flu fails to meet primary endpoint
Revelation Biosciences has announced that a Phase 2b viral challenge study of its REVTx-99a intranasal phosphorylated hexaacylated disaccharide (PHAD) for the prevention of H3N2 influenza in healthy volunteers failed to meet its primary endpoint. The study, which enrolled 30 subjects aged 18 to 55, failed to demonstrate a statistically significant difference in viral … [Read more...] about Phase 2b challenge study of intranasal PHAD for the prevention of H3N2 flu fails to meet primary endpoint
FDA clears IND for Blue Lake intranasal RSV vaccine
CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will evaluate BLB-201 in two different cohorts, one aged 18-59 and the other aged 60-75. According to the company, preclinical studies of BLB-201 in … [Read more...] about FDA clears IND for Blue Lake intranasal RSV vaccine
Intranasal pro-resolving lipid mediators improve cognitive function in mouse model of Alzheimer’s Disease
Researchers from the Karolinska Institutet and Louisiana State University (LSU) Health New Orleans have published an article describing positive effects of intranasal delivery of a cocktail of five different pro-resolving lipid mediators in a mouse model of Alzheimer’s Disease, including improvements in cognitive function. The article, titled "Intranasal delivery of … [Read more...] about Intranasal pro-resolving lipid mediators improve cognitive function in mouse model of Alzheimer’s Disease
Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company's application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the … [Read more...] about Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
Consortium partners with RocketVax on intranasal COVID-19 vaccine development
A Swiss-German consortium led by Volker Thiel of the Institute of Virology and Immunology and the University of Bern has partnered with Swiss startup RocketVax to develop two live attenuated intranasal vaccine candidates against SARS-CoV-2 for planned Phase 1 trials. The consortium, which also includes researchers from the University of Geneva, the Freie Universität … [Read more...] about Consortium partners with RocketVax on intranasal COVID-19 vaccine development
Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor
Pulmatrix has announced that topline data from a Phase 1b study of its PUR1800 dry powder narrow spectrum kinase inhibitor in COPD patients showed that inhaled PUR1800 produced "low and consistent systemic exposure" with "no observed safety signals" In January 2020, when Pulmatrix announced a license agreement with the Lung Cancer Initiative at Johnson & Johnson … [Read more...] about Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor