Bukwang Pharm said its hepatitis B treatment Levovir (ingredient: clevudine) would be the first locally developed drug to be tested in a clinical trial against the new coronavirus.
Company officials said the drug candidate had suppressed the hepatitis B virus even after the end of the drug administration and that they would find whether it would also be effective against the Covid-19 virus.
The Ministry of Food and Drug Safety on Tuesday approved the phase-2 clinical trial of Levovir in 60 domestic patients with moderate to severe Covid-19. The study will compare the efficacy and safety of clevudine with those of hydroxychloroquine, and the results will come out in three or four months, the company said.
The trial will divide patients into two groups. One group will receive clevudine 120mg once daily per person for 14 days (up to 21 days), and the other, hydroxychloroquine 200mg twice a day for 14 days (up to 21 days).
The primary endpoint is the proportion of the patients who test negative for Covid-19 for two consecutive days, with the first test conducted on day 14, compared to the baseline.
The secondary endpoints are as follows: the proportion of subjects who tested negative for two consecutive days on day 4, 8, 15, and 22 days after dosing compared to the baseline; the proportion of subjects who showed improvement in lung invasion on imaging tests compared to the baseline; the cycle threshold value of the viral load on day 4, 8, 15, 22, and 29 after administration; changes in Covid-19 virus levels on day 4, 8, 15, 22 and 29 after dosing; and the proportion of the patients with normal body temperature on day 4, 8, 15, 22, and 29.
The trial will take place at eight hospitals, including Korea University Anam/Guro/Ansan Hospital, Gachon University Gil Medical Center, Ajou University Hospital, Inha University Hospital, Chungnam National University Hospital, and Hallym University Kangnam Sacred Heart Hospital.
Levovir is the nation’s 11th novel drug, and the fourth hepatitis B treatment developed worldwide. Bukwang obtained the local license of Levovir in 2006.
Its main ingredient clevudine blocks viral replication by simultaneously acting on two enzymes involved in the proliferation of the hepatitis B virus, DNA polymerase and reverse transcriptase. It also blocks the DNA supply of the virus into the nucleus, reducing the amount of cccDNA by 20-100 times, according to the company.
Levovir sells only about 1 billion won ($815,043) in the local hepatitis B treatment market but has the potential to become a Covid-19 treatment, Bukwang said. In an in vitro test, the drug inhibited the proliferation of the Covid-19 virus, just like Kaletra, an HIV combo therapy currently being used in the treatment of Covid-19 patients, the company added.
However, Levovir has concerns about side effects such as myasthenia gravis. In the upcoming trial for Covid-19 treatment, the dose of Levovir will be 120 mg, four times higher than the dose for hepatitis B. The company will have to prove the drug’s effect without causing a severe side effect, observers said.
“We set the optimal dose through consultations with the food and drug safety ministry and toxicity tests. There will be no toxicity issue in the study,” a Bukwang Pharm official said.
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