Medical

Meissa Vaccines has announced that interim data from a Phase 1 study of its MV-014-212 intranasal recombinant live attenuated COVID-19 vaccine demonstrate that a single dose produced a good nasal IgA response with no reported safety issues. In July 2020, the company said that the Phase 1 trial had begun dosing subjects. According to the new announcement, the interim … [Read more...] about Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising

Beckley Psytech said that it has initiated dosing in a Phase 1 trial of its intranasal 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT), a psychedelic compound found in the secretions of certain toads. The company is developing the intranasal formulation for the treatment of treatment resistant depression (TRD). The single ascending dose study is expected to enroll up … [Read more...] about Beckley Psytech initiates Phase 1 trial of intranasal 5-MeO-DMT

According to Synairgen, the external data safety monitoring board (DSMB) for the ACTIV-2 study of the company's SNG001 nebulized interferon beta in mild to moderate COVID-19 patients has recommended that the company advance SNG001 into Phase 3. Synairgen said that it has not yet received any data from the ACTIV-2 trial. A Phase 3 trial of SNG001 in hospitalized … [Read more...] about Synairgen gets recommendation to advance its inhaled interferon for mild to moderate COVID-19 into Phase 3

Canadian Biotech Immune Biosolutions said it has initiated a Phase 1 clinical trial of its IBIO123 inhaled antibody therapy, which it is developing for the treatment of COVID-19. According to the company, the trial is being conducted in South Africa and will evaluate IBIO123 versus placebo in patients with symptomatic COVID-19. Earlier this year, the Canadian … [Read more...] about Immune Biosolutions initiates Phase 1 trial of IBIO123 inhaled antibody therapy

Inhalon Biopharma and Celltrion have initiated a Phase 1 study of IN-006 inhaled regdanvimab, Inhalon said. The study is funded in part by a US Army contract worth $7 million.  In July 2021, Inhalon and Celltrion announced that they had partnered to develop the nebulized "muco-trapping" formulation of regdanvimab for the treatment of COVID-19. Celltrion's intravenous … [Read more...] about Phase 1 trial of IN-006 inhaled regdanvimab gets underway

The American Academy of Pediatrics (AAP) has issued a clinical report highlighting serious adverse events related to off-label use of OTC oxymetazoline nasal spray in children before and after surgery, noting that in these situations the drug "may be dosed without attention to the volume administered." The report cites recent cases of young children who suffered … [Read more...] about American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery

According to Revelation Biosciences, the company has received clearance from an ethics committee for an Australian Phase 1b allergen challenge study of its REVTx-99 intranasal phosphorylated hexaacylated disaccharide (PHAD) for the treatment of allergic rhinitis and chronic nasal congestion. The trial, called RVL-CLR01, is expected to begin in the fourth quarter of … [Read more...] about Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis

MannKind Corporation has announced the initiation of the INHALE-1 study of its Afrezza insulin DPI in type 1 and type 2 diabetes patients aged 4-17. The initial 26-week trial will evaluate Afrezza plus basal insulin versus multiple injections of insulin daily and is expected to enroll approximately 260 patients. Following that portion of the trial, all of the subjects … [Read more...] about MannKind initiates Phase 3 trial of Afrezza inhaled insulin in pediatric patients

Blue Lake Biotechnology and its parent company, University of Georgia spin off CyanVac, have announced the initiation of a Phase 1 trial of their CVXGA1 intranasal vaccine for the prevention of COVID-19. CVXGA1 is based on an attenuated strain of canine parainfluenza virus (PIV5). According to the two companies, the intranasal vaccine has demonstrated efficacy against … [Read more...] about CyanVac and Blue Lake Biotechnology initiate Phase 1 trial of CVXGA1 intranasal vaccine for COVID-19