AstraZeneca has announced the US launch of its Airsupra albuterol / budesonide MDI, which was approved by the FDA in January 2023 for the treatment of asthma in people aged 18 and over. Airsupra (PT027) was developed by AstraZeneca subsidiary Pearl Therapeutics. The company points out that the MDI is the only approved SABA/ICS inhaler and the only one that includes … [Read more...] about AstraZeneca launches Airsupra albuterol / budesonide MDI in the US
Medical
PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
PureIMS announced that a Phase 1 PK study that compared the company's Levodopa Cyclops to Inbrija levodopa DPI, demonstrated "high comparability with a marketed inhaled levodopa product," with faster initial absorption and no safety or tolerability concerns reported. The company announced the initiation of the Phase 1 study in August 2023. The company says that it … [Read more...] about PureIMS says it is on a path to an abbreviated application for Levodopa Cyclops DPI based on Phase 1 trial results
Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Pulmatrix announced that it will halt a Phase 2b trial of PUR1900 dry powder itraconazole (Pulmazole) in patients with allergic bronchopulmonary aspergillosis (ABPA) that was initiated in February 2023. The company says that the move is part of an amended agreement with Cipla, which has been partnered with Pulmatrix on development of PUR1900 for the treatment of ABPA … [Read more...] about Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected to enroll 60 PH-ILD patients. The FDA tentatively approved Yutrepia for the treatment of pulmonary … [Read more...] about Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD
Theravance Biopharma announced that the Phase 4 PIFR-2 study of nebulized Yupelri revefenacin inhalation solution versus Spiriva HandiHaler tiotropium DPI in patients with severe to very severe COPD failed to demonstrate any significant difference in the improvement in lung function between the two arms. The company announced the initiation of the 12-week Phase 4 … [Read more...] about Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD
NanoPhoria publishes data on the efficacy of its inhaled lung-to-heart therapy in a pig model
Italian start-up NanoPhoria has announced the publication of an article titled “Lung-to-Heart Nano-in-Micro Peptide Promotes Cardiac Recovery in a Pig Model of Chronic Heart Failure” in the Journal of the American College of Cardiology (JACC). The study, which evaluated a dry powder inhalation formulation of mimetic peptide loaded onto calcium phosphate nanoparticles … [Read more...] about NanoPhoria publishes data on the efficacy of its inhaled lung-to-heart therapy in a pig model
Tiziana initiates Phase 2a trial of intranasal foralumab in non-active secondary-progressive MS
Tiziana Life Sciences announced the initiation of a Phase 2a study of intranasal foralumab in patients with non-active secondary-progressive multiple sclerosis (na-SPMS), with a primary endpoint of change in microglial activation as determined by PET scan. The trial will evaluate 2 doses of foralumab versus placebo and is expected to enroll 18 patients in each arm of … [Read more...] about Tiziana initiates Phase 2a trial of intranasal foralumab in non-active secondary-progressive MS
Vivaldi gets grant to fund preclinical transmission study of its DeltaFlu intranasal universal flu vaccine
Vivaldi Biosciences announced that the Flu Lab has provided a grant to fund a transmission study of the company's DeltaFLU intranasal universal influenza vaccine. According to the company, the study will evaluate the ability of DeltaFlu to protect against transmission of "broadly divergent wild-type influenza type A and B strains" among ferrets. The company noted … [Read more...] about Vivaldi gets grant to fund preclinical transmission study of its DeltaFlu intranasal universal flu vaccine
Ethris initiates Phase 1 trial of nasal and inhaled delivery of ETH47 mRNA therapy
After recently receiving authorization for a Phase 1 trial of its ETH47 mRNA therapy, Ethris has initiated the study, the company announced. The trial is expected to enroll 88 healthy participants aged 18 to 55 and will evaluate the safety, tolerability, and pharmacokinetics of both nasal and inhaled delivery of ETH47, as well as combined nasal/inhaled delivery. The … [Read more...] about Ethris initiates Phase 1 trial of nasal and inhaled delivery of ETH47 mRNA therapy
Agomab announces initiation of Phase 1 trial of AGMB-447 inhaled ALK5 inhibitor
Agomab Therapeutics announced that it has initiated a Phase 1 trial of its AGMB-447 inhaled ALK5 inhibitor that is expected to enroll 76 healthy subjects and idiopathic pulmonary fibrosis (IPF) patients. According to Agomab, the IPF patients will receive AGMB-447 over a two-week period following a SAD/MAD portion of the study in healthy subjects. Agomab Chief … [Read more...] about Agomab announces initiation of Phase 1 trial of AGMB-447 inhaled ALK5 inhibitor