Bukwang Pharmaceutical said it would withdraw its plan to develop its antiviral drug Levovir (clevudine) as a Covid-19 treatment.
The company said it had no intention to work on the drug again.
Industry watchers said Bukwang’s failure to achieve the primary endpoint in a recent trial made it almost impossible to obtain conditional approval, unlike Celltrion’s Regkirona (regdanvimab).
This signals that Bukwang has virtually dropped its plan to develop a Covid-19 drug, they said.
On Thursday, Bukwang said Levovir did not meet the primary endpoint of phase 2 CLV-203 trial for the treatment of Covid-19.
“It was difficult to confirm the effectiveness of Levovir capsules compared to placebo in reducing the viral load, the primary endpoint in the CLV-203 clinical trial, with the majority of patients having mild symptoms,” Bukwang said.
Earlier, the company had said it would repurpose Levovir, a treatment for chronic hepatitis B, as a Covid-19 treatment.
In April, Bukwang obtained the Ministry of Food and Drug Safety’s approval for a phase 2 study (CLV-201) of Levovir in Covid-19 patients with moderate symptoms. However, the company said in May that the investigational drug failed to meet the rate of patients turning negative in Covid-19 test results.
Bukwang said it found a viral load reduction effect of Levovir in hypertensive patients in the phase 2 trial. Then, the company obtained new approval for a second phase 2 study (CLV-203) to test the drug in patients with mild and moderate symptoms. It also changed the primary endpoint to “virus reduction effect.” However, the second trial also failed to yield the desired outcome.
“Levovir capsules tended to lower the viral load in a well-controlled group of moderate patients, but it was difficult to confirm this trend in the group of mild patients,” Bukwang said.
The company still said Levovir showed some effect in mild cases but made it clear that it would not carry out any additional trial.
“It was meaningful to see a virus decreasing trend in hypertensive patients with moderate Covid-19 in the trial, but we have no plan for further development of Levovir as a Covid-19 treatment,” an official at Bukwang said.
After the company announced the trial failure, Bukwang shares nosedived 27.18 percent to close at 15,000 won ($12.65) on Thursday.