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BioWorld - Wednesday, December 17, 2025
Home » Topics » Clinical

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Kidneys

Travere phase III in IgAN positive, ETA next year for sparsentan filing

Aug. 16, 2021
By Randy Osborne
Travere Therapeutics Inc. plans to file for accelerated approval in the first half of next year, based on data from the pivotal phase III Protect study of sparsentan, a dual-acting antagonist of the endothelin type A (ETA) and angiotensin II type 1 receptors, for IgA nephropathy (IgAN).
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Skin irritation on hands

Lilly’s $1.1B Dermira buy looks like good business as phase III eczema trials hit targets

Aug. 16, 2021
By Richard Staines
Eli Lilly and Co.’s $1.1 billion acquisition of Dermira Inc. early last year is looking like a smart move after the company’s atopic dermatitis (AD) drug, lebrikizumab, hit all its targets in two phase III trials. Lebrikizumab is an interleukin-13 antagonist and is part of Lilly’s strategy to build a dermatology portfolio to compete in a market dominated by Sanofi SA and Regeneron Pharmaceutical Inc.’s Dupixent (dupilumab), which was the first injected antibody drug available for AD in 2017. Lilly picked up Dermira, of Menlo Park, Calif., along with lebrikizumab in January last year shortly after the FDA granted lebrikizumab fast track status, paving the way for a potential six-month review.
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Innovent’s sintilimab combo heads toward sNDA filing in gastric cancer

Aug. 16, 2021
By Doris Yu
Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy.
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While clinical activity is up by 9% over last year, pandemic news drops

Aug. 13, 2021
By Karen Carey
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity.
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Artery and plaque

Innovent’s PCSK9 inhibitor meets primary endpoint in phase III HeFH study in China

Aug. 13, 2021
By Doris Yu
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
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In the clinic for Aug. 13, 2021

Aug. 13, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Azurrx, Cali, Equillium, Gigagen, Innovent, Innovation, Longeveron, Lynk, Medivir, Phasebio, Trigone, Ultimovacs, Valneva.
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Figure from journal article showing brain–behavior correlations

Ultrasound improves cognitive performance in Alzheimer's patients

Aug. 12, 2021
By Annette Boyle
A less controversial option than aducanumab may be available soon to help individuals with mild to moderate Alzheimer’s disease-related dementia. Researchers at the Medical University of Vienna and the University of Toronto have developed a technique using ultrasound that reverses cognitive decline and they say it could be available for clinical use shortly.
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Blood sample, DNA

Belief Biomed’s BBM-H901 wins first Chinese IND approval in gene therapy for hemophilia B

Aug. 12, 2021
By Doris Yu
China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.
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No smoking icon

Chantix in a fix, cytisinicline set to Achieve greatness in anti-smoking space?

Aug. 12, 2021
By Randy Osborne
Pfizer Inc.’s voluntary recall of batches of Chantix (varenicline) in mid-July called attention to the smoking-cessation market, where the nicotinic acetylcholine receptor agonist holds lead position, with Glaxosmithkline plc’s Zyban (bupropion) – another oral prescription drug – also a contender. In line to potentially shake up the space with cytisinicline, a plant-based alkaloid, is Achieve Life Sciences Inc.
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Liver disease

Cohbar shares climb as early NAFLD data hint at potential in NASH

Aug. 11, 2021
By Michael Fitzhugh
Shares of Cohbar Inc. (NASDAQ:CWBR) hit a 52-week high on Aug. 11 following news that a mitochondrial peptide analogue it is testing for the potential treatment of nonalcoholic steatohepatitis (NASH) and obesity, CB-4211, delivered "robust" improvements in key biomarkers of liver damage and glucose levels vs. placebo during a small phase Ia/Ib study.
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