MannKind Corporation said that it will advance MNKD-101 clofazimine to a Phase 2/3 study following positive results from a Phase 1 trial of the inhalation suspension delivered via jet nebulizer. The FDA has granted both orphan drug and QIDP designation to MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections. The company also announced the … [Read more...] about MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
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Pulmobiotics publishes data from pre-clinical studies of its live biotherapeutic for the treatment of P. aeruginosa lung infections
Spanish startup Pulmobiotics, a spinout from the Centre for Genomic Regulation (CRG), has published preclinical results in Nature Biotechnology demonstrating that the company's live biotherapeutic reduced drug-resistant P. aeruginosa lung infections in a mouse model. According to Pulmobiotics, inoculation with the modified Mycoplasma pneumoniae doubled the survival … [Read more...] about Pulmobiotics publishes data from pre-clinical studies of its live biotherapeutic for the treatment of P. aeruginosa lung infections
Medical Developments International discontinues planned clinical trials of Penthrox methoxyflurane inhaler in China
Medical Developments International (MVP) said that the company in no longer planning to conduct clinical trials of its Penthrox methoxyflurane inhaler in China due to "extended delays to the anticipated timeline for clinical trial outcomes and consequently the commercial launch of Penthrox in the market, primarily due to the challenging regulatory environment and … [Read more...] about Medical Developments International discontinues planned clinical trials of Penthrox methoxyflurane inhaler in China
Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
Cyrano Therapeutics said that the FDA has cleared the company's IND and that Cyrano now plans to move ahead with a Phase trial of CYR-064 nasal soft mist theophylline in patients who experienced hyposmia (loss of smell) following a viral infection. In December 2020, Cyrano announced that it had raised $12.8 million for a Phase 2 trial of CYR-064. The six-month trial … [Read more...] about Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
Spexis reports results from Phase 1 trial of inhaled murepavadin
Spexis (formerly Polyphor) said that a Phase 1 study of inhaled murepavadin, which the company is developing for the treatment of P. aeruginosa lung infections, demonstrated that the inhaled formulation delivered via the PARI eFlow nebulizer was well tolerated at all dose levels and that concentrations of murepavadin in the lungs reached the desired levels while … [Read more...] about Spexis reports results from Phase 1 trial of inhaled murepavadin
ENA Respiratory gets $4.38 million from US Department of Defense for development of dry powder intranasal formulation of INNA-051
The US Department of Defense Chemical and Biological Defense Program (CBDP) has awarded Australian pharma company ENA Respiratory $4.38 million for development of a dry powder formulation of the company's INNA-051 intranasal pegylated TLR2/6 agonist for protection against a wide range of respiratory viruses, ENA said. According to ENA, the 12-month project is expected … [Read more...] about ENA Respiratory gets $4.38 million from US Department of Defense for development of dry powder intranasal formulation of INNA-051
BiondVax reports positive preclinical results for its NanoAb inhaled nanosized antibodies against COVID-19
BiondVax Pharmaceuticals announced that 6 days post infection, hamsters treated with the company's NanoAb inhaled nanosized antibodies had levels of SARS-COV-2 in their lungs reduced to levels 30 times lower than hamsters that got an inhaled placebo. BiondVax licensed the NanoAb technology from the Max Planck Institute in March 2022 and announced development plans for … [Read more...] about BiondVax reports positive preclinical results for its NanoAb inhaled nanosized antibodies against COVID-19
Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE
Pulmatrix has announced that a Phase 1 PK trial of its PUR3100 dihydroergotamine (DHE) DPI in healthy volunteers demonstrated that all 3 doses tested produced peak exposures in the desired range with a Tmax of 5 minutes post-dose. Subjects receiving PUR3100 also experienced less nausea than those getting IV DHE. Pulmatrix, which is developing PUR3100 for the treatment … [Read more...] about Pulmatrix reports Phase 1 results for PUR3100 inhaled dry powder DHE
Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19
According to the Centenary Institute, the New South Wales COVID-19 Vaccine Acceleration Research Grants Program has awarded a grant worth AU$995,867 to researchers at the Centenary Institute and the University of Sydney to support development of an intranasal vaccine against COVID-19. Sydney-based Ab Initio Pharma, which was recently granted a license to manufacture … [Read more...] about Researchers at the Centenary Institute and the University of Sydney get grant of almost AU$1 million for development of intranasal vaccine against COVID-19
Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients
Armata Pharmaceuticals announced that it has completed the Phase 1b/2a SWARM-P.a. trial of its AP-PA02 inhaled phage cocktail in cystic fibrosis patients who have chronic P. aeruginosa lung infections. The SWARM-P.a. study was initiated in 2020 with support from the Cystic Fibrosis Foundation. In October 2021, the Cystic Fibrosis Foundation and Innoviva made equity … [Read more...] about Armata announces completion of Phase 1b/2a trial of AP-PA02 inhaled phage therapy in CF patients