Daewoong Pharmaceutical's 'Hoistar Tablets' Approved for Severe COVID-19 Phase 3 Clinical Trial

[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical will conduct a Phase 3 clinical trial to determine whether 'Hoistar Tablets' (active ingredient: Camostat Mesylate), being developed as a treatment for COVID-19, are effective for severe COVID-19 patients.

Hoistar Tablets are prescription drugs used for chronic pancreatitis and other conditions, and Daewoong Pharmaceutical is currently developing them as an oral COVID-19 treatment.

According to industry sources on the 4th, the Ministry of Food and Drug Safety recently approved a Phase 3 clinical trial to verify the effectiveness of combining Daewoong Pharmaceutical's Hoistar Tablets with Gilead Sciences' Remdesivir in severe COVID-19 patients.

Unlike the Phase 2/3 clinical trial targeting mild COVID-19 patients, the Phase 3 trial will be conducted on severe patients. The clinical trial institutions include the National Medical Center, and the target number of participants is 1,072.

On the 23rd of last month, Daewoong Pharmaceutical announced interim results of the Phase 2a clinical trial administering Hoistar Tablets to mild COVID-19 patients. A Daewoong Pharmaceutical official stated, "The time taken for COVID-19 patients to test negative was not statistically significant, but the rate at which the virus was eliminated tended to be faster than that of the placebo group."

He added, "These results are interim outcomes from the Phase 2 trial, and the sample size was too small to yield statistically significant results. We plan to continue the clinical trials by expanding the number of patients in the Phase 2/3 trial."

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