Insmed announced that the Phase 3 ARISE study of Arikayce amikacin liposome inhalation suspension demonstrated the effectiveness of the QOL-B questionnaire for patient-reported outcomes. The ARISE study of Arikayce in patients with nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) was initiated in December 2020 with the … [Read more...] about Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
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PureIMS announces planned Phase 1 trial of Levodopa Cyclops
PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled "A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to Inbrija (reference product) in healthy adult subjects" by the end of this year. In April 2023, PureIMS announced … [Read more...] about PureIMS announces planned Phase 1 trial of Levodopa Cyclops
Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company's IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of the Phase 1 trial in October 2021. According to the journal article, the Phase 2 study was stopped early because COVID-19 became … [Read more...] about Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
Galecto has announced that the Phase 2b GALACTIC-1 of its GB0139 inhaled galectin-3 inhibitor for the treatment of idiopathic pulmonary fibrosis failed to meet its primary endpoint and, as a result, the company will discontinue development of the DPI. GALACTIC-1 was initiated in February 2019. In March 2021, Galecto announced that it was discontinuing the higher dose … [Read more...] about Galecto to discontinue development of its GB0139 DPI for the treatment of IPF after Phase 2b trial fails to meet its primary endpoint
Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders
Silo Pharma said that it is planning to develop an intranasal formulation of its SPC-15, which includes "ketamine compositions," for the prevention and treatment of stress disorders, including anxiety and PTSD. The formulation was developed at Columbia University under a sponsored research agreement. According to Silo, US Patent no 11,622,948 ("Biomarkers for Efficacy … [Read more...] about Silo Pharma says it will develop intranasal formulation of SPC-15 ketamine for the treatment of stress disorders
Vistagen says Phase 3 PALISADE-2 trial PH94B fasedienol nasal spray for SAD met primary endpoint
Vistagen has announced that the Phase 3 PALISADE-2 public speaking challenge trial of PH94B fasedienol nasal spray in subjects with social anxiety disorder met its primary and secondary endpoints. The company announced the initiation of PALISADE-2 in September 2021 and then paused the trial in mid-2022 after PALISADE-1 failed to meet its primary endpoint. The trial … [Read more...] about Vistagen says Phase 3 PALISADE-2 trial PH94B fasedienol nasal spray for SAD met primary endpoint
Inimmune initiates Phase 1/1b trial of INI-2004 intranasal TLR4 agonist
Missoula, Montana-based Inimmune Corporation has announced the initiation of Phase 1/1b trial of its INI-2004 intranasal toll-like receptor 4 agonist, which the company is developing for the treatment of allergic rhinitis. According to the company, the Phase 1 SAD portion of the study, which is taking place in Australia, will enroll healthy volunteers and patients … [Read more...] about Inimmune initiates Phase 1/1b trial of INI-2004 intranasal TLR4 agonist
Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
Krystal Biotech announced that it will develop injectable and inhaled versions of its KB707 gene therapy for the treatment of malignant solid tumors, including metastatic cancer. The company said that it intends to amend an existing IND to add a clinical trial of the inhaled formulation by the end of the year, with the trial expected to begin by mid-2024. Krystal … [Read more...] about Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
Insilico Medicine, which claims to be "a generative artificial intelligence (AI)-driven clinical-stage drug discovery company," said that it is "the first AI drug discovery company to venture into nebulized formulations" as the company plans to file an IND for its ISM001-055 inhalation solution for the treatment of idiopathic pulmonary fibrosis. According to the … [Read more...] about Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
Lupin launches Luforbec beclometasone / formoterol MDI in Germany
Lupin announced that its German subsidiary Hormosan Pharma has launched Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD in Germany. According to Lupin, the price of the MDI, which is a generic of Chiesi's Foster (Fostair), will be set at just over half the reference price. Luforbec has been available in the UK since 2021. Hormosan … [Read more...] about Lupin launches Luforbec beclometasone / formoterol MDI in Germany