Medical

ENA Respiratory announced that "an unexpectedly large proportion of participants having pre-existing immunity to the challenge strain" resulted in difficulties interpreting data from a Phase 2a flu challenge study of its INNA-051 pegylated TLR2/6 agonist nasal spray. According to the company, dosing with "a substantial dose of H3N2 influenza A virus" failed to infect … [Read more...] about ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity

Researchers at North Carolina State University have published an article in Nature Materials describing preclinical development of an inhalation powder they are calling "SHIELD" (Spherical Hydrogel Inhalation for Enhanced Lung Defense) that has demonstrated the ability to block viral lung infections in mouse and non-human primate models. Studies found that the SHIELD … [Read more...] about NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models

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

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 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 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 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

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