The broad-spectrum antiviral therapeutic, 'hzVSF-v13(humanized Virus Suppressing Factor)' being developed by ImmuneMed, is on track to progress as a treatment for the COVID-19 pneumonia patients.
Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.
ImmuneMed received approval from the Ministry of Food and Drug Safety(MFDS) for the compassionate use of hzVSF-v13 as treatment of severe COVID-19 and then identified its potential by targeting 7 patients in 4 hospitals. In particular, two COVID-19 pneumonia patients administered at Seoul National University Hospital became virus-free within 10 days by administering hzVSF-v13 twice or three times. They were completely cured of their pneumonia due to reduced clinical symptoms and decreased CRP, the most sensitive marker for acute-phase inflammation, and inflammatory cytokines including IL-6, TNF-a, and MCP-1. The researcher of Seoul National University Hospital published the results as entitled "Compassionate use of hzVSF-v13 in two patients with severe COVID-19" in the Journal of Medical Virology in May 2020.
Prior to this, the safety of hzVSF-v13 has confirmed in Phase 1 clinical study in Korea and another Phase 1 clinical trial is underway in Australia. ImmuneMed carried forward with the Phase 2 clinical trial after analyzing the results of the Phase 1 study and compassionate use of hzVSF-v13 against COVID-19. The Phase 2 clinical study was approved last October, starting from Russia and then Indonesia, Korea, and Italy, sequentially.
Although there will be differences in clinical studies among countries, the company plans to finalize all the Phase 2 clinical studies by sometime next year. Also, based on the Pre-IND meeting feedback, ImmuneMed is preparing an IND application to the FDA and is aiming to initiate the Phase 2 clinical study within the first half of 2021.
hzVSF-v13 is a new drug candidate that ImmuneMed is developing as a treatment for various viral diseases, and the company has been developing treatments for chronic hepatitis B and severe influenza pneumonia. Due to the COVID-19 pandemic, it is also developing COVID-19 treatments based on the research data on coronavirus disease and antiviral efficacy data with SARS-CoV-2. ImmuneMed is also planning to start a Phase 2 clinical study within the first quarter of 2021 regarding chronic hepatitis B which is another indication of hzVSF-v13.
ImmuneMed is a biotech company established in 2000 that develops treatment of viral diseases using hzVSF-v13 and runs a rapid diagnostic kit business for infectious diseases such as COVID-19.