Nocion Therapeutics has announced the initiation of the Phase 2b ASPIRE clinical trial of its NOC-110 inhaled dry powder taplucainium (formerly NTX-1175) in patients with chronic cough. Earlier this year, the company said that it had raised $62 million to conduct the trial, which is expected to enroll approximately 325 patients and will evaluate two dose levels of … [Read more...] about Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
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AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
UK-based start-up AlveoGene announced that its AVG-002 nebulized gene therapy for neonatal surfactant protein B (SP-B) deficiency has received a rare pediatric disease designation from the FDA. The company says that it will advance AVG-002 into clinical development and could submit a marketing application as soon as 2028. According to Alveogene, studies in SP-B … [Read more...] about AlveoGene’s AVG-002 inhaled gene therapy gets rare pediatric disease designation for SP-B deficiency
Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
Tiziana Life Sciences announced that a preclinical study of its intranasal foralumab in combination with semaglutide (Ozempic / Wegovy) demonstrated synergistic effects in a mouse model of obesity, improving liver function and reducing inflammation more than semaglutide alone. The company says that it plans "to advance these promising preclinical findings into … [Read more...] about Tiziana says study of intranasal foralumab in addition to semaglutide demonstrated synergistic effects in mouse model of obesity
MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development
MannKind Corporation has announced that data from a recently completed Phase 1 study of MNKD-201 nintedanib DPI support continued development of the inhaler for the treatment of idiopathic pulmonary fibrosis (IPF). MannKind had announced plans for the Phase 1 SAD/MAD study earlier this year. The announcement includes highlights of safety results and does not present … [Read more...] about MannKind announces that results of Phase 1 trial of MNKD-201 nintedanib DPI support continued development
Kither Biotech announces initiation of Phase 1 trial of KIT2014 inhaled CFTR enhancer
Kither Biotech has announced the initiation of a Phase 1 trial of its KIT2014, an inhaled peptide that the company is developing as a CFTR enhancer for use as an add-on with CFTR modulators for the treatment of cystic fibrosis. The SAD/MAD study is expected to enroll 72 healthy volunteers and will evaluate as many as 6 dose levels of KIT2014 delivered via nebulizer … [Read more...] about Kither Biotech announces initiation of Phase 1 trial of KIT2014 inhaled CFTR enhancer
Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency
Sensory Cloud has announced the publication of an article in ERJ Open Research presenting data from a study of its SC001 intranasal alkaline hypertonic divalent salt in patients with refractory chronic cough (RCC). The company says it will now advance an orally inhaled formulation, SC0023 alkaline hypertonic divalent salt, into a Phase 2a trial. The study, which … [Read more...] about Sensory Cloud says study of its alkaline hypertonic divalent salt aerosol for chronic cough demonstrated significant reduction in cough frequency
AuraVax gets BARDA contract to test its NanoSTING-002 mucosal adjuvant with Codagenix’s intranasal flu vaccine
AuraVax Therapeutics announced that the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded the company a preclinical research contract to support evaluation of AuraVax's NanoSTING-002 mucosal adjuvant with Codagenix's intranasal live attenuated influenza virus (LAIV). In early 2021, AuraVax announced … [Read more...] about AuraVax gets BARDA contract to test its NanoSTING-002 mucosal adjuvant with Codagenix’s intranasal flu vaccine
Orexo initiates study of OX640 epinephrine nasal powder in patients with allergic rhinitis
Orexo announces the initiation of the OX640-002 trial of OX640 epinephrine nasal powder in people with allergic rhinitis, with results expected in early 2025. The new trial is expected to enroll 30 people with allergic rhinitis and includes a test with a nasal allergen introduced prior to the epinephrine in order to compare the absorption of epinephrine with and … [Read more...] about Orexo initiates study of OX640 epinephrine nasal powder in patients with allergic rhinitis
Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI meets primary endpoint
AstraZeneca and Avillion have announced that the Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI as a rescue inhaler in patients with mild asthma met its primary endpoint of reduction in risk of severe exacerbation compared to albuterol alone. The companies say that the independent data monitoring committee recommended an early termination of the trial … [Read more...] about Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI meets primary endpoint
FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says that it plans to initiate the Phase 1 study, which is expected to enroll 24 smokers, by the end of the year. The trial will compare nicotine … [Read more...] about FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine