Korea United Pharm, which is on track to develop what would be the country’s first inhaled formulation to treat Covid-19, aims to start a phase 2 clinical trial sometime in June, the company’s chief executive told Maeil Business Newspaper on Wednesday.
The UI030 project is well underway and a phase 2 study protocol for the drug will be filed with the Ministry of Food and Drug Safety next month, said Korea United Pharm CEO Kang Duk-young, hoping to enter a phase 2 trial around in June.
In an animal model where hamsters were infected with Covid-19, the investigational drug showed a strong antiviral effect of some 90 percent. The drug could work for both mild and severe Covid-19 patients, Kang expected. The animal test was not easy for an inhaled formulation, but the preclinical development process was successfully completed after the company developed a technology that delivers therapeutic substances directly into the lungs of hamsters for pulmonary adsorption.
Inhaled device developed by Korea United Pharm
Unlike oral treatments that pass through the digestive system or injectable antibody treatments delivered through blood vessels, the inhaled therapy is much more effective because it acts directly on the lungs infected with the virus, Kang explained. It is also much more convenient compared to Celltrion’s Rekirona, Korea’s first approved Covid-19 cure, and other available treatments that are administered by injection, which require hospital visits.
In order to reduce the economic burden on patients, Korea United Pharm plans to set the price of the inhaled medicine at the lowest price of $200 to 300 per month, he said.
UI030, a modified combination of budesonide and arformoterol, was repurposed from anti-asthma medication to treat Covid-19 given its strong antiviral effect.
Korea United Pharm has been focusing on developing modified drugs in the local generics-heavy market, generating a high level of profitability. Its operating margin reached 18.6 percent, the highest in the industry last year.
Korea United Pharm is also developing three novel therapies and invests over 10 percent of sales on R&D. The company also plans to increase its overseas presence after the completion of a new oncology plant in Sejong, Korea around in November.
By Chung Ji-sung and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]