Medicox Subsidiary Mecox Curemed Receives Approval for Phase 1 and 2 Clinical Trial Plans of Arthritis Treatment 'Botanix'

[Asia Economy Reporter Jang Hyowon] MedicoXureMed, a subsidiary of MedicoX, a KOSDAQ-listed company, announced on the 17th that it has received approval from the Ministry of Food and Drug Safety for the Phase 1 and Phase 2 clinical trial plans of ‘Bozanics’.

‘Bozanics’ is a natural product-based anti-inflammatory analgesic for osteoarthritis independently developed by MedicoXureMed, a bio company specializing in new drug development. The company expects that the commercialization of ‘Bozanics’ will replace the existing market for similar treatments and also compete with the class of Non-steroidal anti-inflammatory drugs (hereafter NSAIDs).

The company anticipates that ‘Bozanics’ will have superior product competitiveness as it is known to be helpful in treating COVID-19. Recently, a research team led by Professor Shin Jooyoung of Sungkyunkwan University College of Pharmacy published in the international journal Clinical Infectious Diseases that NSAIDs, the competitive treatment group of Bozanics, actually worsen symptoms in COVID-19 patients.

The clinical trials for ‘Bozanics’ will be conducted simultaneously for Phase 1 and Phase 2. After evaluating tolerability in healthy clinical trial subjects in Phase 1, Phase 2 will compare efficacy with the most recently launched NSAIDs. The main objective of the Phase 2 trial is to demonstrate non-inferiority in pain and inflammation suppression compared to the comparator drug and superiority in safety, with efficacy comparisons conducted across various domains.

Six hospitals nationwide, including Bundang Seoul National University Hospital, Ajou University Hospital, Seoul Boramae Hospital, Chung-Ang University Hospital, Chonnam National University Hospital, and Chosun University Hospital, are scheduled to participate in this clinical trial, with a total patient recruitment target of about 200. The first patient enrollment is expected to begin in the first quarter of next year, and the company aims to apply for Phase 3 clinical trials in 2022.

A MedicoXureMed official stated, “Bozanics is a natural product-based new drug with excellent pain suppression and anti-inflammatory effects for osteoarthritis, and it is highly regarded for its safety due to minimal side effects. Since meaningful results have been sufficiently secured during preclinical stages, including pharmacology, efficacy, toxicity tests, and efficacy comparison tests with already approved NSAIDs, good outcomes are expected in Phase 1 and Phase 2 clinical trials as well.”

MedicoXureMed is also working on building the preliminary infrastructure for global approval and sales of ‘Bozanics’. The company reported that it has completed the establishment of an exclusive production and supply system for the active pharmaceutical ingredient (API), producing raw materials using smart farm cultivation methods to ensure stable raw material supply and cultivation history management for quality control.

This content was produced with the assistance of AI translation services.