With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week.
Takeda Pharmaceutical Co. Ltd.’s oral allosteric tyrosine kinase 2 inhibitor TAK-279 (formerly NDI-034858) met primary and secondary endpoints in a phase IIb clinical trial in patients with moderate to severe plaque psoriasis, but analysts say it may be too little too late to make a big splash compared to competitors.
An artificial pancreas system that draws on research conducted at the University of Virginia to effectively combine Dexcom Inc.’s continuous glucose monitor and Tandem Diabetes Care Inc.’s artificial intelligence-enabled insulin pump works effectively in children under 6 years of age with type 1 diabetes, a study published in the New England Journal of Medicine showed.
As it struggles to launch a recently approved drug, Acer Therapeutics Inc. hit pause in its ACER-801 (osanetant) program after top-line data in the phase IIa proof-of-concept study failed to hit statistical significance.
Two research studies by Egnite Inc. presented at the American College of Cardiology Conference (ACC) could shake up the scope of how aortic stenosis (AS) is understood and treated by physicians.
It is approved as a food additive. But it now appears that sucralose can dampen T-cell-mediated immune responses, suggesting it could be a means of treating T-cell-dependent autoimmune disorders. While stressing (repeatedly) that they were studying intakes well above normal, at high but achievable doses sucralose has an unexpected effect on T-cell responses and functions in autoimmune, infection and tumor models, researchers at The Francis Crick Institute, London, reported in Nature March 15, 2023.
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK-021), is advancing from phase I trials to pivotal phase III trials in patients with tenosynovial giant cell tumors (TGCT) in the U.S. and China following clearance from both regulators.
Medical robotics startup Noah Medical Inc. is conducting a first-in-human clinical trial to assess the safety and feasibility of its Galaxy system to improve lung cancer diagnosis. The device received U.S. FDA clearance on March 1 for use in bronchoscopic visualization and accessing patient airways for diagnostic and therapeutic purposes.
One company has developed a promising device and care model to reduce the exacerbations of chronic obstructive pulmonary disease (COPD) that often send patients to the hospital and contribute to accelerated disease progression. Patients who used a wearable remote cardiorespiratory monitoring device developed by Spire Inc. experienced a 64% decrease in cardiopulmonary-specific admissions in a study published in the International Journal of COPD.
Patients with Leber hereditary optic neuropathy who received bilateral injections of Gensight Biologics SA’s Lumevoq (lenadogene nolparvovec) are continuing to see statistically significant visual improvements three years into the phase III REFLECT trial, but the missed primary endpoint at 1.5 years, along with a series of manufacturing mishaps, have left the gene therapy’s approval prospects uncertain.
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