[Asia Economy Reporter Jang Hyowon] MedicoX subsidiary Mecox CureMed has begun Phase 1 clinical trials of the arthritis treatment drug ‘Bozanix’ in collaboration with Seoul National University Bundang Hospital (Professor Jae-Yong Jung, Department of Clinical Pharmacology).
Mecox CureMed announced that it has signed the main contract with Seoul National University Bundang Hospital to conduct Phase 1 clinical trials of ‘Bozanix’ and has started recruiting 32 healthy adult participants for the clinical trial. The company plans to commence dosing for Phase 1 clinical trials as early as this month once participant recruitment is complete. Mecox CureMed is a new drug development specialist company, with MedicoX, a KOSDAQ-listed company, holding the largest shareholder position.
Along with initiating the Bozanix Phase 1 clinical trial, which focuses on safety evaluation, the company intends to accelerate its plans by concretizing Phase 2 clinical trials involving at least 150 participants across six institutions including Seoul National University Bundang Hospital, Seoul Boramae Hospital, Ajou University Hospital, Chonnam National University Hospital, Chosun University Hospital, and Chung-Ang University Hospital. The Phase 2 trial will primarily focus on comparing the efficacy between the latest non-steroidal anti-inflammatory drugs (NSAIDs) and Bozanix.
In December last year, Mecox CureMed received simultaneous approval from the Ministry of Food and Drug Safety for the Phase 1 and 2 clinical trial plans of Bozanix. The company stated that since the initial clinical plan approval process, which usually takes a long time during new drug R&D, has been completed, it aims to conduct the clinical trials swiftly and apply for Phase 3 clinical trials by next year.
A Mecox CureMed representative said, "The Phase 1 clinical trial of Bozanix will thoroughly verify basic safety data, and in Phase 2, we plan to demonstrate non-inferiority in pain and inflammation suppression compared to the comparator drug, as well as prove superiority in safety. Besides Bozanix, we expect meaningful outcomes this year from various ongoing overseas clinical studies, including the oral anticancer new drug Mecbentu, which is awaiting clinical plan approval."
Bozanix is a natural product-based anti-inflammatory analgesic for osteoarthritis developed by Mecox CureMed. It is composed of a single substance, offering excellent pain relief and anti-inflammatory effects for osteoarthritis with minimal side effects. In preclinical studies focusing on pharmacology, efficacy, and toxicity, significant results were obtained in efficacy comparisons with existing non-steroidal anti-inflammatory drugs (NSAIDs).
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