Daewoong Pharmaceutical's COVID-19 Treatment 'CoviBlock', Key Results of Phase 2b Clinical Trial Announced

[Asia Economy Reporter Lee Chun-hee] Daewoong Pharmaceutical has announced the topline results of the Phase 2b clinical trial for its COVID-19 treatment candidate, "Koviblock" (tentative name). Among patients aged 50 and above, the time taken for respiratory symptom improvement was reduced to less than half compared to the placebo group.

Daewoong Pharmaceutical announced the topline results of the Phase 2b clinical trial of Koviblock (active ingredient: Camostat Mesylate), which is being developed as a COVID-19 treatment, on the 27th.

This clinical trial was conducted from February to July at 24 institutions in South Korea. Among 342 mild COVID-19 patients, 327 who took either Camostat or placebo participated in a placebo-controlled, randomized, double-blind study. The primary endpoint was the "time taken for clinical symptoms to improve," while key secondary endpoints included "safety" and the "proportion of patients who worsened." Clinical symptoms included seven symptoms: feverishness, cough, shortness of breath, chills, muscle pain, headache, and sore throat. Improvement was defined as the symptom severity (rated 0 to 3) being "none (0)" or "mild (1)" and maintained for 24 hours.

Analysis showed that the time taken for clinical symptom improvement was 7 days in the Camostat group versus 8 days in the placebo group, with no statistically significant difference. In terms of safety, Camostat was confirmed to be safe in all patients who received it.

Daewoong Pharmaceutical noted that due to the characteristics of mild patients?who generally manage symptoms well, have a high natural recovery rate, and show low medication adherence?it was difficult to confirm differences in the time to symptom improvement. In fact, no severe patients were present in either the treatment or placebo groups in this trial. This aligns with recent trends of decreasing fatality rates despite the ongoing spread of COVID-19.

However, the research team confirmed statistically significant results among patients who took at least 70% of the provided Camostat or placebo doses during the trial period. Among 175 patients who had at least one respiratory symptom?cough or shortness of breath?which are the most representative symptoms of COVID-19 and key indicators of symptom worsening (86 in the Camostat group and 89 in the placebo group), the time to symptom improvement was 5 days in the Camostat group, approximately 40% faster than the 8 days in the placebo group, showing statistically significant results.

Notably, among patients aged 50 and above, who have a higher probability of progressing to severe disease, the time to respiratory symptom improvement was reduced to 4 days in the treatment group compared to 9 days in the placebo group, less than half the time. This statistical difference was observed in the analysis of 98 patients aged 50 or older who had at least one symptom of cough or shortness of breath (48 in the treatment group and 50 in the placebo group). Additionally, among patients who experienced respiratory symptom worsening requiring oxygen therapy even once, only one patient was in the Camostat group compared to six in the placebo group, representing about 15%, a very low level.

Based on these research results, Daewoong Pharmaceutical stated that given the various variables in COVID-19, larger-scale studies are needed to confirm consistent efficacy across all patients. However, they explained that effectiveness was confirmed in symptom improvement among mild patients with respiratory symptoms or those aged 50 and above. A company official commented, "Since a significant effect on respiratory symptom improvement was observed in patients aged 50 and above, who have a higher risk of progressing to severe disease, and given the current rapid spread of COVID-19 without available oral treatments, prompt discussions with experts are expected to be necessary."

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "We will fulfill our social responsibility as a pharmaceutical company to overcome COVID-19 by considering all possible options, including the development of a nasal spray formulation that can block the infection route of the coronavirus itself and research on combination therapies with other treatments."

This content was produced with the assistance of AI translation services.