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BioWorld - Saturday, March 14, 2026
Home » Topics » Clinical

Clinical
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Shaky hands holding glass

ET left behind as Zurzuvae ship flies for Sage, Biogen in PPD

July 24, 2024
By Randy Osborne
A phase II failure with SAGE-324 in essential tremor (ET) had Wall Street speculating about the fate of Sage Therapeutics Inc.’s partnership with Biogen Inc. Shares of Cambridge, Mass.-based Sage (NASDAQ:SAGE) ended July 24 at $10.38, down $2.70, or 20.6%, after the firm disclosed top-line results from the phase II Kinetic 2 dose-ranging study of oral SAGE-324 (also known as BIIB-124) for ET. The trial did not show a statistically significant dose-response relationship based on the primary endpoint, the Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (upper limb) total score.
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Cerebellum, brain stem, spinal cord

Alterity’s ATH-434 shows early response in multiple system atrophy

July 23, 2024
By Tamra Sami
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
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Infant receiving vaccine

Merck’s RSV antibody for infants hits late-stage study endpoints

July 23, 2024
By Lee Landenberger
Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
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Tape measure wrapped around scale

Gan & Lee’s long-acting GLP-1 shows weight loss in phase IIb

July 23, 2024
By Tamra Sami
Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.
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Red dart in center of red target

Innovent’s mazdutide hits phase III endpoints in type 2 diabetes

July 23, 2024
By Tamra Sami
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
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Aveo’s kidney cancer combo flops in PIII; LG Chem soldiers on

July 23, 2024
By Marian (YoonJee) Chu
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
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Limb exam

Post-Vyvgart nod, players flex muscle in CIDP and beyond

July 22, 2024
By Randy Osborne
The U.S. FDA approval won in June by Argenx SE of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) sparked interest in other prospects taking aim at the rare disease. Some – including Argenx – are going after generalized myasthenia gravis and multifocal motor neuropathy with their compounds.
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Red dart in center of red target

Innovent’s mazdutide hits phase III endpoints in type 2 diabetes

July 22, 2024
By Tamra Sami
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
Read More

Aveo’s kidney cancer combo flops in PIII; LG Chem soldiers on

July 22, 2024
By Marian (YoonJee) Chu
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
Read More
Brain illustrated with pills

Neumora’s KORA for a win in MDD? J&J in the phase III mix, too

July 19, 2024
By Randy Osborne
A schizophrenia drug in Cerevel Therapeutics Inc.’s lineup understandably stole much of the thunder during coverage of Abbvie Inc.’s takeover late last year to the tune of $8.7 billion, but much further back in the pipeline awaits another potentially lucrative prospect: a kappa opioid receptor antagonist (KORA) for major depressive disorder (MDD).
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