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BioWorld - Monday, December 15, 2025
Home » Topics » Clinical

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Artery and plaque

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

Aug. 17, 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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Innovent’s sintilimab combo heads toward sNDA filing in gastric cancer

Aug. 17, 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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Blood sample, DNA

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

Aug. 17, 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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Santosh Chandrasekaran holding SEEG electrode

Brain implant evokes sensation in fingers, may show path to restoring sense of touch

Aug. 17, 2021
By Annette Boyle
Using a minimally invasive brain implant, Feinstein Institutes for Medical Research scientists produced tingling sensations in the fingers of patients who lacked the sense of touch as a result of nerve damage, according to a study published in Brain Stimulation. A second study by the team, which appeared in Frontiers in Neuroscience, used stereoelectroencephalography (SEEG) electrodes to decode neural signals to improve the hand control algorithms in brain-computer interfaces.
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Revolution takes turn in SHP2 campaign; other combo efforts continue, too

Aug. 17, 2021
By Randy Osborne
Though Revolution Medicines Inc.’s SHP2 inhibitor, RMC-4630, fell short of internally set benchmarks in a pair of phase I combo trials, the prospect remains alive, as the company has been “very publicly moving towards combining the companion inhibitors that we have, which include RMC-4630 with RAS inhibitor therapies that we and others make,” said Steve Kelsey, president of R&D.
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In the clinic for Aug. 17, 2021

Aug. 17, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amerimmune, Axcella, Biophytis, Biosight, Brickell, Eli Lilly, Enanta, Innocare, Innovent, Moderna, Oramed, Praxis, Sagimet, Senhwa, Tikomed, Travere, Turning Point.
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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.
Read More

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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