Inhalable Regkirona found safe in Phase 1 clinical trial

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Celltrion said Monday Phase 1 clinical trials of an inhalable form of Regkirona produced meaningful results confirming safety.

Since August 2020, Celltrion has been working with Inhalon Biopharma to develop an inhalable form of Regkirona, its Covid-19 treatment, which allows for the conveying of the treatment directly into the airways using an inhaler.

The Durham, North Carolina-based company conducted the Phase 1 clinical trials on 24 healthy people in Australia and observed no significant side effects during the trials.

Celltrion has also been developing an inhalable Covid-19 antibody cocktail treatment. The treatment is a combination of monoclonal antibodies with CT-P59, also known as Regkirona, and CT-P63, the another candidate substance from the company.

Earlier the year, the Songdo, Incheon-based company shared the results of the clinical trials of the CT-P63 demonstrating safety. The candidate also produced antibodies neutralizing the Omicron variant, it said.

Celltrion submitted applications to start global Phase 3 clinical trials of the cocktail treatment candidate in Bosnia, Serbia and the Republic of North Macedonia. The company plans to add more countries to the list to conduct the trials on a total of 2,200 patients with light and moderate symptoms to test safety and efficacy.

"We've been accelerating the development of Covid-19 treatments by confirming the safety of the inhalable form of Regkirona in its Phase 1 clinical trials and starting the global trials of the cocktail treatment," said a spokesperson for Celltrion. "We will try our best to collect patients so that we can acquire meaningful interim results as soon as possible."

BY SARAH CHEA [chea.sarah@joongang.co.kr]