As Celltrion has formalized the development of an inhaled treatment for the novel coronavirus infection (COVID-19), interest is being drawn on whether the inhaled treatment can become a new treatment option for COVID-19.
On the 16th, Celltrion announced that it had started developing Inhalon Biopharma (hereinafter referred to as Inhalon), a biotech company based in the US, and inhaled Lekkorna (ingredient name: Legdanvirab). The reason for the development was explained to be to diversify treatment options.
This is not the first time Celltrion has mentioned its plan to develop an inhaled COVID-19 treatment.
At the Leqirona online press conference held by Celltrion in February, Honorary Chairman Seo Jeong-jin (then chairman) said, “I think that inhaled drugs are more useful than subcutaneous injections.” It also hinted at the potential for development.
However, Celltrion has kept quiet about developing an inhaled COVID-19 treatment several times, saying, “Nothing has been decided.”
Regarding the change in Celltrion’s position, there are opinions in the industry that it may have disclosed the fact of development as the development entered its trajectory. According to Celltrion, Inhalon submitted data to the Australian Ethics Committee to start a phase 1 clinical trial of inhaled lekkorona in June, and plans to confirm its effectiveness in phase 2.
In the case of inhaled Rekkona, the antibody is delivered directly to the airway mucosa infected with the Corona 19 virus. Celltrion expects to increase access to COVID-19 treatment and patient convenience by easily administering Rekkona at home through an inhaler.
A Celltrion official said, “We will do our best to develop an inhaled lekkona so that we can provide various treatment options for COVID-19 patients.”
While Celltrion plans to conduct clinical trials for inhaled COVID-19 treatment overseas, United Pharmaceutical Korea is currently developing ‘UI030’, a candidate material for inhaled COVID-19 treatment, in Korea.
Korea United Pharm received approval for UI030 Phase 2 (ABC study, Arformoterol/Budesonide for Covid-19 study) from the Ministry of Food and Drug Safety on May 31st. UI030 Phase 2 will be conducted on 100 COVID-19 patients (adult males 19 years of age or older).
UI030 is an improved drug candidate for budesonide and aformoterol, which has been developed as an asthma treatment by United Pharmaceutical Korea for the past 7 years, and has been being developed as a treatment for COVID-19 since last year.
Korea United Pharm conducted UI030 Phase 1 for the purpose of asthma treatment for 40 healthy adult men in Korea last year, and AstraZeneca Korea’s Inhaled Asthma and Chronic Obstructive Pulmonary Disease (COPD) inhaled treatment ‘Symbicoat Tabuheller (ingredient name budesonide) )’, safety and tolerability were evaluated.
Korea United Pharm judged that it had proven safety through this and went straight to phase 2 with the indication of COVID-19.
After the IND approval in May, the number of clinical trial institutions has also been expanded. From one Boramae Hospital in Seoul, Korea Veterans Welfare and Medical Service Central Veterans Hospital and National Medical Center were added, increasing the total number to three.
Patients participating in the clinical trial will be orally inhaled twice a day (2 times once) in the morning and evening for a total of 14 days, and if asymptomatic, the administration is stopped.
“We will take the lead in overcoming the crisis by completing the development of a treatment for COVID-19 as soon as possible,” said an official at United Pharmaceutical Korea.
Meanwhile, Korea United Pharmaceutical received GMP certification for its UI030 production plant from the Daejeon Regional Food and Drug Administration on the 1st.