CyanVac has announced the initiation of a Phase 2b clinical study of CVXGA intranasal COVID-19 vaccine shortly after the company announced results from its Phase 2a trial. The Phase 2b trial, which is expected to enroll 10,000 participants, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and will be conducted by the BARDA clinical … [Read more...] about CyanVac initiates Phase 2b trial of CVXGA intranasal COVID-19 vaccine
Medical
Tiziana announces expansion of Phase 2 trial of intranasal foralumab for SPMS
Tiziana Life Sciences announced that a Phase 2a clinical of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS) has been expanded to include additional trial sites at Yale, Johns Hopkins, Cornell, Thomas Jefferson University, SUNY Buffalo, and UMass. The trial was initiated at the end of 2023 at Brigham and Women's … [Read more...] about Tiziana announces expansion of Phase 2 trial of intranasal foralumab for SPMS
Blue Lake and CyanVac report data from Phase 2a trial of CVXGA intranasal COVID-19 vaccine
Blue Lake Biotechnology and CyanVac reported that a Phase 2a clinical trial of their CVXGA intranasal vaccine against SARS-CoV-2 demonstrated that participants who received CVXGA had a 78% lower risk of symptomatic infection one month post vaccination compared to those who got a placebo. The study enrolled 227 participants. In addition, the companies said that no … [Read more...] about Blue Lake and CyanVac report data from Phase 2a trial of CVXGA intranasal COVID-19 vaccine
Tiziana receives ALS Association grant to fund trial of intranasal foralumab in patients with ALS
The ALS Association, which supports research on amyotrophic lateral sclerosis, has awarded a grant to Tiziana Life Sciences to support a clinical trial of intranasal foralumab in 20 patients with ALS at Massachusetts General Hospital, Tiziana said. The amount of the award was not disclosed. According to Tiziana, the trial will use PET imaging to evaluate the … [Read more...] about Tiziana receives ALS Association grant to fund trial of intranasal foralumab in patients with ALS
Nocion initiates Phase 2b trial of NOC-110 taplucainium DPI for the treatment of chronic cough
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
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