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
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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
Intranasal Ampligen found to be well tolerated in safety study
Hemispherx Biopharma has announced that a safety study of Ampligen plus FluMist in 25 healthy volunteers showed that intranasal Ampligen was generally well tolerated. Ampligen is a TLR-3 agonist, which the company is already developing for the treatment of chronic fatigue syndrome and for solid tumors. In previous studies of Ampligen for those indications, the … [Read more...] about Intranasal Ampligen found to be well tolerated in safety study
Positive results from Phase 3 safety study of nebulized revefenacin
Theravance Biopharma and Mylan have announced that a 12-month Phase 3 safety study of nebulized revefenacin (TD-4208) showed that the drug was well tolerated, with low rates of adverse events and serious adverse events that were comparable to a standard of care treatment arm. The 52-week safety study compared 2 doses of revefenacin to tiotropium. Half of the … [Read more...] about Positive results from Phase 3 safety study of nebulized revefenacin
Opiant Pharmaceuticals reports results from Phase 1 study of intranasal naltrexone for alcohol use disorder
Opiant Pharmaceuticals has announced results from a Phase 1 trial of OPNT002 intranasal naltrexone, which it is developing for the treatment of alcohol use disorder (AUD). According to the company, which recently announced that it had licensed Aegis Therapeutics' Intravail absorption enhancers for use with its opioid antagonists, the addition of Intravail to … [Read more...] about Opiant Pharmaceuticals reports results from Phase 1 study of intranasal naltrexone for alcohol use disorder
Positive Phase 1 results for Samumed’s inhaled Wnt signaling modulator
Samumed has announced positive results from a Phase I trial of an inhalation solution of its novel Wnt signaling modulator SM04646, which the company is developing for the treatment of idiopathic pulmonary fibrosis (IPF). The study enrolled 17 healthy subjects and delivered 4 ascending doses of SM04646 in a single inhalation via nebulizer. All doses were well … [Read more...] about Positive Phase 1 results for Samumed’s inhaled Wnt signaling modulator