ImmuneMed is accelerating efforts to develop hzVSF-v13, an investigational antiviral treatment for chronic hepatitis B, and pushing to go public on Kosdaq this year.
Separately, the biotech firm has been working on hzVSF-v13 as a Covid-19 treatment. The company’s start of the drug development for chronic hepatitis B draws attention to whether the results will lead to a successful initial public offering.
On Friday, ImmuneMed said it won regulatory approval for its plan for phase-2a trial of hzVSF-v13 to treat chronic hepatitis B.
ImmuneMed said it confirmed hzVSF-v13’s “functional cure” in some individual woodchuck models as they lost woodchuck hepatitis virus surface antigen (WHsAg) in animal tests.
The phase-2a study will occur at Samsung Medical Center, the Seoul National University Hospital, and the Severance Hospital. ImmuneMed said it would begin the first administration in June at the earliest.
In the study, patients taking nucleic acids (NAs) will receive four intravenous injections every 28 days. Then, the researchers will check the reduction of hepatitis B surface antigens and their disappearance rates.
ImmuneMed has also been studying hzVSF-v13’s potential as a Covid-19 treatment since last year.
According to ImmuneMed, hzVSF-v13 trials for Covid-19 treatment began in four countries – Korea, Russia, Indonesia, and Italy.
The company obtained the nod from the Ministry of Food and Drug safety for the phase-2 study to test the antiviral drug in Covid-19 patients with moderate to severe symptoms in December. ImmuneMed will compare the standard care with the combination of the standard therapy and each dose of hzVSF-v13 to assess the drug’s efficacy and safety.
ImmuneMed hopes to complete the IPO on Kosdaq within this year.
“We haven’t set a detailed timeframe, but we plan to begin the IPO process in the second half,” an official at ImmuneMed said.
ImmuneMed is likely to use the regulator’s technology exception policy that many biotech venture startups prefer. The policy makes listing easier for small companies with technological competitiveness.
ImmuneMed said it plans to get a technology evaluation this month. Companies must receive “A” and higher than “BBB” rating from two rating agencies designated by the Korea Exchange to be listed under the technology exception policy.