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BioWorld - Wednesday, January 21, 2026
Home » Topics » Clinical

Clinical
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Cholesterol plaque in artery

Lib’s lerodalcibep hits co-primary endpoints in phase III HeFH trial

Aug. 29, 2023
By Karen Carey
Heterozygous familial hypercholesterolemia (HeFH) patients treated with lerodalcibep achieved a 58.6% reduction in LDL-cholesterol at week 24 and a 65% reduction at the mean of weeks 22 and 24 in the phase III trial Liberate-HeFH. The developer, Cincinnati-based Lib Therapeutics Inc., was founded in 2015 when it licensed the technology from Bristol Myers Squibb Co. but is just now emerging from stealth.
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Acinetobacter baumannii

Omnix lining up phase II trial of insect-derived antibiotic

Aug. 28, 2023
By Cormac Sheridan
Omnix Medical Ltd. is gearing up for a phase II trial next year of its novel peptide-based antibiotic OMN-6, the lead compound in a pipeline inspired by the antimicrobial strategies of insects.
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Teen receiving vaccine

CHIKV vaccine fever on rise as Valneva phase III follows Bavarian Nordic data

Aug. 28, 2023
By Randy Osborne
About two weeks after chikungunya virus (CHIKV) vaccine contender Bavarian Nordic A/S provided phase III data with its prospect, rival Valneva SE rolled out positive phase III safety findings in adolescents with its single-dose candidate VLA-1553. Results from the Saint-Herblain, France-based company’s first trial in an endemic area with people previously infected with CHIKV showed the product was generally safe and well-tolerated in subjects aged 12-17 years, regardless of previous infection by the mosquito-borne disease, carried mainly by Aedes aegypti and Aedes albopictus. Immunogenicity data from the study are expected in November.
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Syringe and capsules atop lab chart
Biopharma clinical updates July 2023

Clinical trial data down from 2021 but up 18% from 2019

Aug. 25, 2023
By Amanda Lanier
The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the 2,402 in 2021 and down from 2020’s 2,096, but up 18.15% from 2019’s 1,747.
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Heart with blocked arteries

Merck’s phase III Coralreef program brings oral bid to PCSK9 ecosystem

Aug. 25, 2023
By Randy Osborne
Merck & Co. Inc. is pledging major resources on its prospect in the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor space with a phase III program that together will enroll about 17,000 subjects and test oral peptide MK-0616’s effect on tackling low-density lipoprotein cholesterol.
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DBS for stroke

EDEN trial shows DBS improves movement in stroke patients

Aug. 25, 2023
By Annette Boyle
A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities up to three years after a stroke. Results of the study were published in Nature Medicine.
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Microscope with slide

cMET begets cadets from well-armed pharma big and small

Aug. 24, 2023
By Randy Osborne
Apollomics Inc.’s business combination this spring with Maxpro Capital Acquisition Corp., along with data that emerged from competitors Merck KGaA and Johnson & Johnson during the more recent American Society of Clinical Oncology meeting, shone a spotlight on continuing efforts to develop mesenchymal-epithelial transition factor (cMET) inhibitors.
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Tarsier’s eye drop for uveitis misses phase III endpoint; silver lining?

Aug. 24, 2023
By Marian (YoonJee) Chu
A nonsteroidal eye drop formulation of dazdotuftide, TRS-01 missed its late-stage primary endpoint for controlling inflammation in uveitis, but developer Tarsier Pharma Ltd. said post-hoc analysis showing a boosted benefit-risk profile over steroids may be a ray of hope.
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Cancer cells being destroyed by immunotherapy

Lucky leak? TIGIT targeters rise on accidental disclosure by Roche

Aug. 23, 2023
By Jennifer Boggs
The narrative of TIGIT-targeting immunotherapy development, beset by negative news in recent months, has found a positive plotline again, thanks to what Roche Holding AG referred to as “an inadvertent disclosure” of a second interim analysis from the phase III Skyscraper-01 study testing anti-TIGIT candidate tiragolumab with anti-PD-L1 antibody Tecentriq (atezolizumab) in non-small-cell lung cancer.
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Mindrhythm's headset

Headset could improve safety of return-to-play decisions after concussion

Aug. 23, 2023
By Meg Bryant
For many sports injuries, return-to-play decisions are pretty straightforward: pain and swelling have dissipated, or an X-ray confirms that a bone has healed. For concussion, it’s not so clear. Though symptoms may resolve after a few days, the brain could still be vulnerable. Now, Cupertino, Calif.-based based startup Mindrhythm Inc. has developed a headset to assess concussion recovery using biometric measures and help doctors safely return concussed individuals to play.
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