Pneumagen has announced the initiation of a Phase 1 SAD/MAD study of its Neumifil carbohydrate binding module (mCBM) nasal spray, which the company is developing for the prevention and treatment of viral respiratory infections. The company said that it expects topline results to be available in the first half of 2022. At the beginning of 2021, Pneumagen announced … [Read more...] about Phase 1 trial of Pneumagen’s Neumifil nasal spray gets underway
Medical
CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Armata Pharmaceuticals announced that the Cystic Fibrosis Foundation has purchased $3 million worth of the company's common stock and that Innoviva subsidiary Innoviva Strategic Opportunities, which already held a significant number of shares in Armata, has invested a further $4 million. The funds will be used to support further development of the company's lead … [Read more...] about CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide
According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF's dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and … [Read more...] about Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide
Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising
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 initiates Phase 1 trial of intranasal 5-MeO-DMT
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
Synairgen gets recommendation to advance its inhaled interferon for mild to moderate COVID-19 into Phase 3
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
Immune Biosolutions initiates Phase 1 trial of IBIO123 inhaled antibody therapy
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
Phase 1 trial of IN-006 inhaled regdanvimab gets underway
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
American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery
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
Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis
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