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.
Top-line results of a phase II study of RXC-004, a porcupine inhibitor for treating certain Wnt ligand-dependent cancers, are not good enough to continue development as a monotherapy for biliary tract cancer, according to Redx Pharma plc. Despite the monotherapy arm not hitting progression-free survival at six months, the Porcupine2 study continues with its other treatment arm, this one using Keytruda (pembrolizumab, Merck & Co. Inc.). Data from that arm are set to come in the second half of 2023.
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
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