Acesion Pharma ApS reported that its lead drug candidate AP-30663 hit the primary endpoint of a phase II trial in atrial fibrillation (AF). The study had an adaptive design, which allowed for the recruitment of up to 108 patients experiencing an active AF episode, but the study investigators saw sufficient efficacy after a blinded evaluation of just 63 patients to terminate at that point. The study, which began shortly before the COVD-19 pandemic, had been underway for three years at that stage.
Les Laboratoires Servier SAS is touting its phase III win with vorasidenib as the first major advance in decades for low-grade glioma, with the trial called Indigo scoring statistical significance on two measures against residual or recurrent isocitrate dehydrogenase-mutant disease. The Suresnes, France-based firm said Indigo met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis proved not only statistically significant but also clinically meaningful in PFS and TTNI.
Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause.
Implantica AG reported that the first two Refluxstop procedures to treat acid reflux have been performed at Getafe University Hospital in Spain. Trial results indicate that the single-use passive medical implant can cure reflux in 98% of cases without the need for medication.
Irvine Calif.-based Inari Medical Inc. reported results from what it described as the largest prospective study of interventional treatment in high-risk pulmonary embolism (PE), which found a 90% survival improvement in high-risk pulmonary embolism using the company’s Flowtriever System. Data from the FLAME (Flowtriever for Acute Massive Pulmonary Embolism) study in high-risk PE was presented at the 2023 American College of Cardiology (ACC) conference on March 5.
Swiss orphan biotech AB2 Bio Ltd. has completed enrollment in a pivotal phase III trial for its recombinant interleukin-18-binding protein drug tadekinig alfa for an inherited form of the ultra-rare condition hemophagocytic lymphohistiocytosis that results from an excess of the pro-inflammatory cytokine IL-18.
Bionomics Ltd. is gearing up for an end-of-phase-II meeting with the U.S. FDA later this year to discuss the full results from the phase II study called Prevail in social anxiety disorder (SAD) with BNC-210, which missed its primary endpoint but yielded encouraging signs. Top-line data were disclosed last December. An oral alpha-7 nicotinic acetylcholine receptor negative allosteric modulator, BNC-210 fell short in change from baseline to the average of the Subjective Unites of Distress Scale (SUDS) during a five-minute public speaking challenge.
Marking the latest Alzheimer’s disease (AD) disappointment, Eli Lilly and Co.’s solanezumab failed in a phase III trial to slow progression of cognitive decline in patients at the preclinical stage of the disease – those with amyloid plaque but no clinical symptoms – prompting the company to terminate development. The Indianapolis-based company is turning its attention instead to phase III AD products donanemab and remternetug.
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
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