[팜뉴스=이권구 기자] Shinpoong Pharmaceutical (CEO Yoo Je-man) selected the UK as the first overseas country where the global phase 3 clinical trial of ‘Pyramax Tablet’, which is being developed as an oral COVID-19 treatment, will be conducted, and approved the clinical trial plan with the British Medicines Agency (MHRA) It was announced on the 18th that it applied for
This clinical trial is a global phase 3 clinical trial to confirm the efficacy and safety of Pyramax Tablet in mild-to-moderate COVID-19 patients, including in Korea, Europe (UK, Poland, Russia), South America (Argentina, Chile), and Southeast Asia ( A total of 1,420 subjects will be recruited from seven countries including the Philippines).
The clinical trial will be conducted in a multicenter, randomized, double-blind, parallel, placebo-controlled, superiority trial at ‘North Manchester General Hospital’, ‘Broomfield Hospital’, UK, from February 2022 to December 2022.
The company plans to solicit clinical trial plans in Poland (January 25, 2022) Russia (January 25, 2022) Argentina (January 28, 2022) and Chile (February 10, 2022).
The company said, “In the in vitro drug efficacy test and infective virus reduction test measured by RT-PCR, SARS-CoV-2 was effectively inhibited when pyronaridine and altesunate were treated alone. Pyramax, a pyronaridine-altesunate combination drug, is expected to minimize the possibility of transition to severe disease and death as a treatment for COVID-19 by showing continuous antiviral efficacy.”
Meanwhile, in Korea, phase 3 clinical trials were approved by the Ministry of Food and Drug Safety on August 27 last year, and clinical trials are underway at 26 clinical trial institutions, starting with the first patient registration on October 18. The domestic phase 3 clinical trial is part of a multinational clinical trial.
