Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in … [Read more...] about Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient
Medical
Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The … [Read more...] about Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Blue Water Vaccines said that it intends to develop its BWV-201 intranasal Streptococcus pneumoniae vaccine candidate for the prevention of non-invasive pneumococcal pneumonia. The company is already developing the live attenuated intranasal vaccine, which it licensed from St. Jude Children’s Research Hospital, for the prevention of acute otitis media in children. … [Read more...] about Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial
Disappointing data from a Phase 1 study of intranasal delivery of AstraZeneca's ChAdOx1 nCoV-19 vaccine against COVID-19 led researchers from the University of Oxford to conclude that there is a "need for further development of nasal spray vaccines," the university said. The researchers reported the results in The Lancet's eBioMedicine. Intranasal delivery of the … [Read more...] about Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial
United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
United Therapeutics has announced the initiation of the Phase 3 TETON 2 trial of Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis (IPF). In December 2020, the company announced that the FDA had granted orphan drug designation to treprostinil for the treatment of IPF and had cleared an IND for the Phase 3 TETON program. The TETON 1 … [Read more...] about United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
Intravacc gets funding for intranasal gonorrhea and betacoronavirus vaccines
Dutch intranasal vaccine developer and CDMO Intravacc said that it has received an award of up to $14.6 million from the US National Institute of Allergy and Infectious Diseases (NIAID) to support development of an intranasal vaccine against gonorrhea and another award of up to $4.8 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support … [Read more...] about Intravacc gets funding for intranasal gonorrhea and betacoronavirus vaccines
Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19
Synairgen has announced that the Phase 2 ACTIV-2 trial of SNG001 inhaled interferon-beta-1a in non-hospitalized COVID-19 patients failed to show a statistically significant reduction in hospitalization, viral load, safety, or resolution of symptoms compared to placebo, but the study did demonstrate a relative reduction of 86% in hospitalization. Over the course of the … [Read more...] about Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19
Odyssey Health says Phase 1 results for PRV-002 intranasal therapy for concussion support advancing the nasal powder to Phase 2
Odyssey Health announced that it has completed its Phase 1 study of PRV-002, a novel intranasal synthetic neurosteroid powder formulation that the company is developing for the treatment of concussion, and said that the results support advancing PRV-002 into Phase 2 trials. Odyssey acquired PRV-002 from Prevacus in January 2021. The company recently announced that the … [Read more...] about Odyssey Health says Phase 1 results for PRV-002 intranasal therapy for concussion support advancing the nasal powder to Phase 2
Wake Forest University School of Medicine gets Alzheimer’s Association grant for Phase 2 trial of intranasal insulin
According to Atrium Health Wake Forest Baptist, Wake Forest University School of Medicine has received a two-year $795,000 grant from the Alzheimer’s Association to support a Phase 2 trial of empagliflozin and intranasal insulin for Alzheimer's disease. The trial will be led by Wake Forest professor Suzanne Craft, who is director of the Alzheimer's Disease Research … [Read more...] about Wake Forest University School of Medicine gets Alzheimer’s Association grant for Phase 2 trial of intranasal insulin