Medical

After recently receiving authorization for a Phase 1 trial of its ETH47 mRNA therapy, Ethris has initiated the study, the company announced. The trial is expected to enroll 88 healthy participants aged 18 to 55 and will evaluate the safety, tolerability, and pharmacokinetics of both nasal and inhaled delivery of ETH47, as well as combined nasal/inhaled delivery. The … [Read more...] about Ethris initiates Phase 1 trial of nasal and inhaled delivery of ETH47 mRNA therapy

Agomab Therapeutics announced that it has initiated a Phase 1 trial of its AGMB-447 inhaled ALK5 inhibitor that is expected to enroll 76 healthy subjects and idiopathic pulmonary fibrosis (IPF) patients. According to Agomab, the IPF patients will receive AGMB-447 over a two-week period following a SAD/MAD portion of the study in healthy subjects. Agomab Chief … [Read more...] about Agomab announces initiation of Phase 1 trial of AGMB-447 inhaled ALK5 inhibitor

Nasus Pharma said that in a second PK study of FMXIN002 intranasal dry powder epinephrine, 91% of subjects who received a 4 mg dose of the nasal formulation reached the clinical threshold for plasma exposure at 6 minutes post dose compared to 51% who received a dose of epinephrine from an EpiPen. The company reported results from the initial PK study in June 2021. … [Read more...] about Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine

Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics in June 2022 and announced plans to develop ACP-101 for hyperphagia in PWS … [Read more...] about Acadia announces initiation of Phase 3 trial of ACP-101 carbetocin nasal spray for hyperphagia in PWS

Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis patients into a Phase 2b/3 trial "subject to regulatory feedback and availability of sufficient funding." The study data demonstrated limited efficacy, with culture … [Read more...] about BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial

Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company's RespiRx vibrating mesh nebulizer platform. In September 2022, the company announced that it had raised $17 million for development of the nicotine replacement product. The Phase 1 PK study enrolled 12 … [Read more...] about Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy

According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company's SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and veterans. The Phase 2 Department of Defense PTSD Adaptive Platform Trial (NCT05422612), which is expected to be … [Read more...] about US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD