Novoteris has announced that Health Canada has okayed a planned Phase 2a clinical trial of the company's Thiolanox inhaled nitric oxide gas for the treatment of non-tuberculous mycobacteria (NTM) lung infections. The study will enroll 10 patients excluded from an ongoing Phase 2 trial of Thiolanox in cystic fibrosis patients. In 2015, the company received $2.8 … [Read more...] about Novoteris announces plans for Phase 2a trial of Thiolanox for NTM lung infections
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Impel Neuropharma initiates Phase 1 trial of INP104 intranasal dihydroergotamine
Impel NeuroPharma has announced the initiation of a Phase 1 trial of INP104 intranasal dihydroergotamine (DHE), which the company is developing for the treatment of acute migraine headache. The bioavailability study, which is taking place in Australia, will compare INP104 to an approved intravenous DHE formulation and to Valeant's Migranal DHE nasal spray, the … [Read more...] about Impel Neuropharma initiates Phase 1 trial of INP104 intranasal dihydroergotamine
Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Evoke Pharma says that a comparative exposure PK study has shown that 2 out of 3 doses of its Gimoti metoclopramide nasal spray demonstrated bioequivalence to oral metoclopramide and, based on those results, the company plans to submit a 505(b)(2) NDA for Gimoti early in 2018. Evoke is developing Gimoti for the treatment of diabetic gastroparesis. In December … [Read more...] about Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis
Spyryx Biosciences has announced the initiation of the Phase 2 HOPE-1 study of SPX-101, an inhaled SPLUNC1-derived peptide, in cystic fibrosis patients. The 28-day study is designed to enroll as many as 78 CF patients and will compare two doses of SPX-101 against a placebo. In June 2017, Spyryx announced an increase in an award from Cystic Fibrosis Foundation … [Read more...] about Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis
Real world study of Stiolto Respimat vs LAMA/LABA/ICS gets underway
Boehringer Ingelheim, insurer Anthem, and Anthem's research subsidiary HealthCore have announced the initiation of the AIRWISE study, which will compare Stiolto Respimat tiotropium bromide/olodaterol SMI to any commercially available combination of LAMA, LABA, and ICS for the reduction of COPD exacerbations in a real world setting. Results are expected in 2020. The … [Read more...] about Real world study of Stiolto Respimat vs LAMA/LABA/ICS gets underway
Synairgen considers developing its inhaled interferon beta for COPD
Synairgen has announced that it is considering development of its SNG001 inhaled interferon beta for the treatment of COPD. SNG001 was previously in development for the prevention of exacerbations caused by viral lung infections in asthma patients. In 2012, the company announced positive results from a Phase 2 study demonstrating that SNG001 produced statistically … [Read more...] about Synairgen considers developing its inhaled interferon beta for COPD
Savara initiates Phase 3 trial of AeroVanc for MRSA lung infections in CF patients
Savara has announced the initiation of a Phase 3 study of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The AVAIL study is expected to enroll about 200 patients who will receive either twice daily AeroVanc or an inhaled placebo in the first portion of the study over … [Read more...] about Savara initiates Phase 3 trial of AeroVanc for MRSA lung infections in CF patients
Positive Phase 3 results for AstraZeneca’s Duaklir DPI for COPD
AstraZeneca has announced positive top-line from the Phase 3 AMPLIFY study of the Duaklir aclidinium bromide/formoterol DPI in patients with moderate to very severe COPD. The study met its primary endpoints by demonstrating statistically significant improvement in lung function for patients using Duaklir compared to the individual components and by demonstrating … [Read more...] about Positive Phase 3 results for AstraZeneca’s Duaklir DPI for COPD
Insmed to seek accelerated approval of ALIS based on positive Phase 3 study results
Now that the Phase 3 CONVERT study has met its primary endpoint of culture conversion with statistical and clinical significance by Month 6, Insmed said, the company plans to seek priority review and accelerated approval from the FDA for its ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacteria (NTM) lung infections The … [Read more...] about Insmed to seek accelerated approval of ALIS based on positive Phase 3 study results
Altimmune submits IND for NasoVax
Altimmune has submitted an investigational new drug application to FDA for its NasoVAX intranasal flu vaccine and is planning a Phase 2 study of the product, the company said. The safety and immunogenicity study is anticipated to enroll 60 volunteers, with data available in early 2018, and is expected to be followed by a larger immunogenicity study for a quadrivalent … [Read more...] about Altimmune submits IND for NasoVax