Bukwang Pharmaceutical Co., Ltd. announced the topline result of CLV-201, the Phase 2 clinical trial of Levovir as COVID-19 treatment.
CLV-201 is randomized, placebo-controlled, single blinded Phase 2 study to evaluate the safety and efficacy of Levovir in patients diagnosed with moderate COVID-19. Study evaluated clinical efficacy and safety between 41 patients in the Levovir group and 20 patients in the placebo group.
The study only enrolled the patients in the Negative Pressure Room at University Hospital, not from the Residential Treatment Center. It became a crucial factor which delayed the timeline of the study, but was able to maintain the highest quality.
Main result of CLV-201 showed that there was a more clear tendency of virus reduction in patients who were treated with Levovir when compared to patients in the placebo group.
Subgroup analysis was conducted with 22 hypertension patients, and patients who had N gene showed statistically significant virus reduction in the Levovir group when compared to the placebo group. (p<0.05)
Also, the study revealed that patients who participated in the study within 7 days after onset of symptom showed greater tendency of virus reduction with Levovir when compared to the placebo. It is now understood that being treated in the early stage is more effective in treating the disease.
Bukwang valued the study as very meaningful, because the study showed Levovir was effective in reducing viruses, which is the most important indicator in terms of developing antiviral treatment. Throughout the study, there were no major adverse events reported.
Negative conversion rate of COVID-19 at the end of observation (Day-29) was 85.3% in the Levovir group (vs. Placebo 76.5%). Result was not able to reach statistical significance, but more patients who were treated with Levovir showed Negative conversion. When Bukwang obtained the approval, the company set Negative conversion rate as the primary endpoint. However, the importance of this endpoint is getting decreased since there is much literature that still argues that there is no standard criteria to define Negative, and there are some cases which do not include in clinical studies.
Recently, European Medicines Agency (EMA) proposed the reduction of the virus as evidence to support and recommend the use of COVID-19 treatment. Likewise, global pharmaceutical companies set the primary endpoint of clinical study with the reduction of viruses. Therefore, it is now becoming an important indicator to measure therapeutic effects of antiviral agents.
Bukwang confirmed that Levovir has potential to reduce virus from CLV-201 clinical study, and currently ongoing study, CLV-203, which enroll mild-to-moderate patients, will confirm additional information whether Levovir is also effective in reducing infectious virus. Once data from both CLV-201 and CLV-203 are secured, Bukwang is planning to discuss with authority about future plans.
Primary endpoint of CLV-203 clinical study is to evaluate viral reduction through a plaque assay, which is a widely used approach for determining the quantity of infectious virus. In this study, patients are eligible to participate within 7 days of onset of symptoms.
The ongoing clinical study, CLV-203, has already recruited ~73% of patients, and it is expected to complete the enrollment within this month.
Bukwang strictly complies with Good Clinical Practice (GCP) and makes the utmost effort in clinical study in order to ensure the reliable data