- Improvement of symptoms such as cough and dyspnea in mild patients over age 50 was reported to be as twice as fast and statistically significant in the treatment group (4 days) compared to the placebo control group (9 days).
- Development is underway for potential combination therapies and novel nasal spray formulations.
SEOUL, South Korea, July 29, 2021 /PRNewswire/ -- Daewoong Pharmaceutical (CEO Sengho Jeon) announced its phase 2B clinical trial topline results for Foistar (Camostat mesilate), which is being developed as a treatment for COVID-19.
The placebo-controlled, randomized, and double blinded clinical trial was conducted from February to July of this year at 24 different clinical institutions in South Korea. Among 342 mild COVID-19 patients, 327 patients were administered with either camostat or a placebo.
The primary endpoint aimed to assess the time taken to improve clinical symptoms with major secondary endpoints being treatment safety and rate of exacerbation. A total of seven clinical symptoms including fever, cough, shortness of breath, chills, muscle pain, headache, and sore throat were evaluated as modeled from various COVID-19 clinical trials. Symptoms were scored based on their severity (1-3) and was determined to be improved when a score of 0 (none) or 1(mild) was reached and maintained for 24 hours. Concomitant uses of antipyretic analgesics were allowed for a conservative treatment.
The analysis results demonstrated safety being confirmed in all patients receiving camostat. While varying medication adherence hindered statistical significant for the entire patient pool, a general trend of clinical symptom improvement was observed in the treatment group in seven days as opposed to eight days for the placebo group. None of the participants required advanced treatments including high-flow oxygen therapy.
Among 175 medication-compliant patients (86 patients from the treatment group, 89 patients from the placebo group) who experienced at least one respiratory symptom indicative of exacerbation, statistically significant symptom improvement was observed on day 5 in the treatment group as opposed to the placebo group taking eight days to recover, suggesting a 40% faster recovery rate. A greater rate of 50% was reported to be statistically significant from seniors over the age of 50 who were at risk of developing severe COVID-19.
As a result of comparing the time taken to symptom improvement for 98 patients (48 patients from the camostat group, 50 patients from the placebo group) who experienced cough or shortness of breath, the rate of improvement was as twice as fast and statistically significant (four days as opposed to nine). In addition, only a single patient from the treatment group required low flow oxygen treatment as opposed to six patients from the placebo group.
Patient trials for COVID-19 has been quite cumbersome due to disease-related variabilities such as time of infection, age, symptoms, patient's past and current medical condition, but also conditional factors such as the mandatory quarantine following a positive diagnosis. Hence, additional studies are needed to confirm identical efficacy in all forms of patients.
Nevertheless, Daewoong Pharmaceutical has verified effectiveness in improving symptoms in patients with respiratory symptoms especially for those above 50 years of age with mild COVID-19 symptoms. The fact that approximately 80% of participating patients were administered with antipyretic analgesics that are minimally effective on its own suggests a potential combination therapy in the future. With no oral COVID-19 treatment currently available, any promising lead is judged to be worthy of further investigation.
CEO Sengho Jeon of Daewoong Pharmaceutical commented, "Going forward, we will fulfill our responsibility in community as a pharmaceutical company to overcome COVID-19 by considering every possible option. This would include combined treatments and developing a patient-friendly nasal spray that can effectively block COVID-19."
About Daewoong Pharmaceutical. Co., Ltd.
Daewoong Pharmaceutical. is a global healthcare corporation founded in 1945 with the belief to 'create good medicine to protect the health of the people and create a healthy society.' Major business areas are hospital prescription drug (ETC) sector, over-the-counter medicine (OTC) sector, exportation of finished products and raw material medicine sector, and consignment production sector. Daewoong continues to invest more than 10% of its sales in R&D every year, focusing on developing gastrointestinal(GI), endocrine, orphan and stemcell based therapeutics.
For further information, please contact:
Cheolheon Park(firstname.lastname@example.org), Daewoong Pharmaceutical PR manager