Tonix Pharmaceuticals has announced the initiation of the Phase 2 PREVENTION study of the company's TNX-1900 intranasal potentiated oxytocin for the prevention of migraine headaches. Tonix licensed TNX-1900 for the treatment of migraine from Trigemina in June 2020, and the company announced in November 2021 that the FDA had cleared an IND for a Phase 2 trial of … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
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Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Seelos Therapeutics said that it has initiated a Phase 1 study comparing PK profiles of SLS-002 intranasal racemic ketamine in Japanese and non-Asian adults. In May 2021, the company announced positive Phase 2 results for SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The intranasal ketamine is delivered … [Read more...] about Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Pulmatrix has announced the initiation of a Phase 2b trial of its PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma. In 2020, PUR1900 received fast track designation for that indication. Pulmatrix is partnered with Cipla subsidiary Cip Tec on development of the itraconazole DPI, which it has previously called … [Read more...] about Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
Vistagen has announced the initiation of a Phase 1 clinical trial of its PH10 pherine nasal spray, which the company is developing for the treatment of major depressive disorder. In November 2022, the company announced that it had gotten the go-ahead for the Phase 1 trial of a new formulation of PH10 from the FDA, and the agency granted Fast Track designation to PH10 … [Read more...] about Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
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
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