TWi Pharmaceuticals, Inc. today announced that its fully owned subsidiary, TWi Biotechnology, Inc., has received US FDA and Taiwan FDA approval of a protocol for a Phase II clinical trial of its AC-201 controlled-release (CR) tablets for the indications of high blood uric acid level and gout. The company will start to enroll patients for the Phase II clinical trial as soon as possible.
"We are very pleased with the approval of the Phase II clinical trial protocol for AC-201 CR." said Dr. Calvin C. Chen, President of TWi Biotechnology. "The purpose of this Phase II trial is to determine the effectiveness of AC-201 CR in reducing uric acid levels in the blood of gout patients. This is a joint effort by TWi Biotech and its parent company, TWi Pharma, in applying TWi Pharma's controlled-release drug delivery platform. We developed a safer and higher bioavailability formulation than the original instant-release formulations. The upcoming trial will assess the efficacy and safety of this new formulation. We hope to provide gout patients a new treatment that can control their uric acid level without worsening the complications of gout. The currently available drugs either have safety concerns or increase the frequency of gout flares, reducing the compliance of regular drug dosing by patients. TWi aims to address the unmet needs in the gout therapy, by developing a new treatment that is safer, more effective, and more attractive to patients."
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