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Home » Topics » Clinical

Clinical
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Sciwind moves to once-weekly dosing after oral GLP-1 delivers strong phase I obesity data

Jan. 24, 2024
By Tamra Sami
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
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Biontech and Dualitybio progress HER2 ADC to pivotal trials in China in metastatic breast cancer

Jan. 23, 2024
By Tamra Sami
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
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Gilead disappoints with top-line phase III data in metastatic NSCLC

Jan. 22, 2024
By Jennifer Boggs
What had been viewed as a major catalyst for Gilead Sciences Inc. going into 2024 turned into a disappointment on the stock market, as antibody-drug conjugate Trodelvy (sacituzumab govitecan) failed to meet the overall survival primary endpoint in the phase III Evoke-01 study in previously treated metastatic non-small-cell lung cancer (NSCLC).
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Liver illustration

Sagimet soars with phase IIb NASH data

Jan. 22, 2024
By Lee Landenberger
Sagimet Biosciences Inc. stock (NASDAQ:SGMT) more than doubled Jan. 22 as shares closed 170% higher at $18.42 each as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the 52-week, randomized, double-blind Fascinate-2 trial showed the oral fatty acid synthase inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis, which is moderate to severe disease, at week 52.
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Gene therapy next in HCM? Tenaya making strides

Jan. 18, 2024
By Randy Osborne
With one approved myosin inhibitor on the market and another coming up fast, researchers such as those at Tenaya Therapeutics Inc. are casting for new strategies to treat hypertrophic cardiomyopathy (HCM).
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Girl in wheelchair

Step Rett up: Acadia’s Daybue comes on strong as others in the works, too

Jan. 18, 2024
By Randy Osborne
After the U.S. FDA granted clearance in March 2023, sales began promptly of Acadia Pharmaceuticals Inc.’s new Rett syndrome therapy, Daybue (trofinetide), and questions during the recent J.P. Morgan Healthcare Conference in San Francisco had to do with – among other matters – sales guidance from the firm, which is hardly alone in seeking treatments for the disease. Other players include Anavex Life Sciences Corp., Neurogene Inc. and Taysha Gene Therapies Inc.
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Dxcover diagnostic

Dxcover launches troika of trials to evaluate efficacy of cancer test

Jan. 18, 2024
By Shani Alexander
Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.
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Clostridioides difficile bacteria

Acurx’s ibezapolstat posts positive phase II data but stock slips

Jan. 17, 2024
By Lee Landenberger
Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate ibezapolstat but that didn’t stop the stock from tumbling. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients.
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Close up of man's eye

Developers in TED cruise toward phase III days in the sun; Tepezza to feel the chill?

Jan. 17, 2024
By Randy Osborne
Kriya Therapeutics Inc.’s unveiling of its new gene therapy program for thyroid eye disease (TED), KRIYA-586, added yet another player to the burgeoning space, where a handful of developers have reached the phase III stage.
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Layoff, shutdown illustration

Lirentelimab out on failed phase II data; Allakos restructures

Jan. 16, 2024
By Karen Carey
Allakos Inc. terminated all development of its lead drug, anti-Siglec-8 antibody lirentelimab (AK-002), and is cutting its workforce in half, following phase II failures for atopic dermatitis and chronic spontaneous urticaria. The San Carlos, Calif.-based company will now focus on phase I trials for anti-Siglec-6 antibody AK-006 as part of a restructuring that stretches the runway into mid-2026. Shares (NASDAQ:ALLK) sank by 60.2%, down $1.80, to close at $1.19 on Jan. 16.
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