9 stories mentioning TPE:6919Updated 2d ago
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Caliway Biopharmaceuticals (TPE:6919) said Health Canada approved an amendment to the protocol for its pivotal Phase 3 CBL-0302 clinical study of CBL-514.The study, named SUPREME-02, is evaluating CBL-514 for improving the appearance of abdominal subcutaneous fat, according to a Friday filing.The amended CBL-0302 study has been approved to proceed in the U.S., Canada and Australia, the company said.
Caliway Biopharmaceuticals (TPE:6919) said the U.S. FDA's 30-day review period for an amended Phase 3 protocol for CBL-514 in abdominal subcutaneous fat reduction has been cleared.The SUPREME-02 study will enroll about 320 participants and assess CBL-514's safety and effectiveness in reducing abdominal fat, according to a Monday filing.
Caliway Biopharmaceuticals (TPE:6919) submitted an amended protocol for CBL-514, an investigational drug being developed to reduce subcutaneous fat and treat moderate-to-severe cellulite and Dercum's disease, to the US FDA and Health Canada.The amendment covers the CBL-0302 pivotal Phase 3 trial, which will evaluate CBL-514 for improving the appearance of abdominal subcutaneous fat in about 320 participants, according to a Monday Taiwan Exchange filing.The company submitted the amended protocol after FDA recommendations, it said.
Caliway Biopharmaceuticals (TPE:6919) submitted an investigational new drug (IND) application to China's National Medical Products Administration's Center for Drug Evaluation for a phase one study of abdominal fact reduction drug.The CBL-0102 trial will evaluate the safety, tolerability and pharmacokinetic profile of CBL-514 in about 30 healthy Chinese subjects, following completion of a pre-IND meeting with the regulator.The company said the localized phase 1 study will assess potential racial differences in the drug's efficacy and safety between Chinese and non-Chinese populations, with a China phase 3 application planned after the phase 1 study is completed.
Caliway Biopharmaceuticals (TPE:6919) submitted an investigational new drug application for a phase 2 clinical trial of CBL-0201WR to the U.S. Food and Drug Administration (FDA).The company aims to study the product in combination with tirzepatide to reduce abdominal subcutaneous fat in overweight or obese adults, according to a Monday Taiwan bourse filing.The company expects to enroll 120 subjects for the trial in the U.S.CBL-0201WR is indicated for subcutaneous fat reduction, treating moderate to severe cellulite, and Dercum's Disease.
Caliway Biopharmaceuticals (TPE:6919) said the US Food and Drug Administration has allowed its investigational new drug application for CBL-0303, a Phase 3b long-term follow-up study of CBL-514 for reducing abdominal subcutaneous fat, to proceed after the 30-day review period.The study in the U.S. is expected to enroll about 300 participants who completed the company's pivotal Phase 3 trials to evaluate the long-term safety and durability of CBL-514's efficacy.It will assess the drug's long-term safety and whether its effectiveness in reducing abdominal subcutaneous fat is maintained over time, with eligible participants also able to receive re-treatment.
Caliway Biopharmaceuticals (TPE:6919) said the U.S. Food and Drug Administration has completed its 30-day review of an investigational new drug application for a Phase 3b study of CBL-514, allowing the trial to proceed.CBL-514 is an injectable treatment for reducing abdominal fat, according to a Friday Taiwan Exchange filing.The study, known as CBL-0303, will assess the long-term safety and durability of the drug's fat-reduction effect in participants who completed the company's Phase 3 trials.The company has not yet begun the new drug application process, the filing said.
Caliway Biopharmaceuticals (TPE:6919) completed its U.S. FDA IND submission for a Phase 3b long-term follow-up study of its abdominal subcutaneous fat reduction drug, according to a Wednesday Taiwan Exchange filing.The study, dubbed CBL-0303, is designed to evaluate long-term safety and maintenance of efficacy of the drug called CBL-514, before the trail.It is expected to enroll around 300 participants in the United States. The protocol also includes an optional re-treatment phase for eligible patients, the filing said.
Caliway Biopharmaceuticals (TPE:6919) completed a U.S. FDA IND submission for the phase three clinical trial for a fat reduction drug, according to a Monday Taiwan Exchange filing.Shares rose about 5% in Tuesday's afternoon trade.The study will evaluate the drug, dubbed CBL-514, for abdominal subcutaneous fat reduction.The randomized, double-blind, placebo-controlled trial will enroll about 320 participants across the U.S., Canada and Australia.The company said the application was submitted on Monday and is currently under review, the filing said.
