Krystal Biotech has announced the initiation of the Phase 1 CORAL-1/US dose escalation trial of its KB407 inhaled gene therapy for the treatment of cystic fibrosis. The Phase 1 study, which is being conducted at the Cystic Fibrosis Institute of Chicago, is expected to enroll approximately 20 CF patients who will receive either KB407 delivered over 30 minutes on 1 day, … [Read more...] about Krystal Biotech initiates Phase 1 study of KB407 inhaled gene therapy for CF
Medical
Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay
MannKind Corporation has filed a notice with the US Securities and Exchange Commission (SEC) stating that manufacturing of clinical trial supplies for its planned Phase 2/3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacteria (NTM) lung infections will be delayed up to 6 months due to a fire at the facility that was set to … [Read more...] about Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay
TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
According to TFF Pharmaceuticals, the company has received a 3-year Direct to Phase 2 Small Business Innovation Research (SBIR) grant worth ~$2.97 million from the National Institute of Allergy and Infectious Diseases (NIAID) for further pre-clinical development of a dry powder pan-influenza vaccine formulation based on the company's thin film freezing technology. The … [Read more...] about TFF gets almost $3 million from NIAID for development of dry powder universal flu vaccine
Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
US-based start-up Cystetic Medicines has announced the initiation of a Phase 1 SAD/MAD trial of its CM001 dry powder "molecular prosthetic" in healthy volunteers. The company is developing CM001 for the treatment of cystic fibrosis and said that it plans to evaluate the DPI in CF patients later this year. CM001 is based on technology developed by Martin Burke of the … [Read more...] about Cystetic initiates Phase 1 trial of CM001 “molecular prosthetic” DPI
MannKind initiates Phase 4 INHALE-3 trial of Afrezza inhaled insulin
MannKind Corporation has announced the initiation of the Phase 4 INHALE-3 study of its Afrezza DPI in type 1 diabetes patients. The trial is expected to enroll approximately 120 type 1 diabetes patients who currently use an insulin pump. Over the course of the 17-week study, one group will continue their usual insulin delivery method, and another group will use … [Read more...] about MannKind initiates Phase 4 INHALE-3 trial of Afrezza inhaled insulin
Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
According to Pieris Pharmaceuticals, AstraZeneca has stopped a Phase 2a trial of elarekibep (PRS-060/AZD1402), an inhaled IL-4 receptor alpha inhibitor that the companies were developing for the treatment of asthma. In the announcement, Pieris said that it has been informed by AstraZeneca that pathology results from a 13-week toxicology study of inhaled dry powder … [Read more...] about Phase 2a study of Pieris and AstraZeneca’s elarekibep DPI discontinued
Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
Vistagen said that a Phase 1 study of itruvone (PH10) nasal spray, which the company is developing for the treatment of major depressive disorder, found that itruvone was well tolerated with no serious adverse events. The company had announced the initiation of the study to evaluate a new formulation of PH10 in January 2023. PH10 for the treatment of major … [Read more...] about Vistagen reports results of Phase 1 study of itruvone (PH10) nasal spray
Acadia Pharmaceuticals to develop intranasal carbetocin for the treatment of hyperphagia in PWS
Acadia Pharmaceuticals announced that it will develop ACP-101 (formerly LV-101) intranasal carbetocin for the treatment of excessive hunger in Prader-Willi syndrome (PWS). Acadia acquired the rights to the nasal spray when it acquired Levo Therapeutics in June 2022. Levo had licensed the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and initiated Phase 3 … [Read more...] about Acadia Pharmaceuticals to develop intranasal carbetocin for the treatment of hyperphagia in PWS
Vistagen announces results from Phase 2a trial of PH80 epoxyestrenolone nasal spray for the treatment of hot flashes
Vistagen announced that a Phase 2a trial of the company's PH80 intranasal epoxyestrenolone in menopausal women experiencing hot flashes demonstrated statistically significant reduction in the frequency and severity of the hot flashes. The company acquired PH80 when it acquired Pherin Pharmaceuticals earlier this year and the Phase 2a trial was conducted by Pherin at … [Read more...] about Vistagen announces results from Phase 2a trial of PH80 epoxyestrenolone nasal spray for the treatment of hot flashes
InhaleRx initiates Phase 1 trial of IRX211 dronabinol MDI
Australian inhaled cannabis developer InhaleRx (formerly Lifespot Health) announced the initiation of a Phase 1 SAD study of the company's IRX211 inhaled dronabinol, a synthetic THC. According to the company, IRX211 was formulated by "a specialized inhalation expert group based in the UK," and the clinical trial batch was manufactured by Ab Initio Pharma. InhaleRx is … [Read more...] about InhaleRx initiates Phase 1 trial of IRX211 dronabinol MDI