ImmuneMed said its inflammatory viral disease treatment HzVSF (humanized virus suppressing factor) would effectively work against the new coronavirus.
The company refuted criticism that the candidate drug’s therapeutic effect on Covid-19 in clinical trials could have resulted from the combination with Kaletra, an HIV drug.
ImmuneMed CEO Kim Yoon-won stressed that the Covid-19 virus was “completely killed” in four out of seven patients with severe Covid-19 symptoms who received HzVSF, in a news conference at the Korea Bio Park in Pankyo, Gyeonggi Province, on Monday.
“The patients initially received Kaletra, but their symptoms did not improve. So, we used our drug together, and it worked. We can’t say this was the effect of the combination therapy,” he said.
ImmuneMed has received temporary approval from the Ministry of Food and Drug Safety to use HzVSF for eight Covid-19 cases. Among them, seven individual patients received HzVSF treatment at Yeungnam University Hospital in Daegu, Seoul National University Hospital, Severance Hospital, and Chungnam National University Hospital.
According to Kim, the HzVSF-treated seven patients were so seriously ill that they had to rely on ventilators and extracorporeal membrane oxygenation (ECMO). They received the standard therapy, including Kaletra, but the therapy did not show effectiveness.
Physicians added HzVSF, and four out of the seven patients had the Covid-19 killed, and the other two improved symptoms. After symptoms improved, the doctors discontinued HzVSF. The other one patient received plasma therapy but died due to underlying diseases, including lung cancer.
“The initial administration of HzVSF improves symptoms within two or three days. A patient who had a damaged heart and lungs filled with fluid received our drug, and the fluid was gone,” Kim said.
The physicians added HzVSF only after the conventional therapy did not work, so the treatment should not be considered as a combination therapy, he emphasized, adding that it is also difficult to say that the patients naturally recovered.
However, Kim noted that a patient with lung fibrosis would not recover even with the use of HzVSF.
ImmuneMed obtained additional approval for the use of HzVSF for many people and is waiting for the Institutional Review Board’s assessment on the drug at each university hospital. The hospitals can use the drug for up to 24 Covid-19 patients.
The company said it would solidify the efficacy of HzVSF in a phase-2 clinical trial. It plans to seek approval for the study in June and start the trial in July. Also, the company hopes to begin a phase-2 study in Italy for compassionate use in July.
“I think HzVSF can save 80 percent of critically ill Covid-19 patients. If we complete a phase-2 study successfully, we will be able to get conditional approval,” Kim said.