Rekirona (CT-P59), Celltrion’s investigational neutralizing antibody therapy for Covid-19, have met efficacy and safety endpoints in an analysis from a Phase 2 randomized placebo-controlled trial, providing some hope for the availability of Korea’s first coronavirus cure.

According to the top-line results released during an academic conference organized by Pharmaceutical Society of Korea on Wednesday, the intravenous therapy (40㎎/㎏) shortened time to clinical recovery, while significantly reducing progression rates to severe Covid-19 by 54 percent for mild-to-moderate patients and 68 percent for moderate patients aged 50 years and over.

Only four patients in the treatment group (n=101) progressed to severe conditions that require hospitalization, whereas the comparative figure was nine in the placebo arm (n=103).

The treatment group also reported with significantly shortened time to clinical recovery of median 5.4 days, 3.4 days earlier than those in the placebo group.

In addition, patients treated with CT-P59 rapidly and significantly reduced viral load through Day 7 compared to placebo. The therapy also showed a positive safety profile with no mortality or serious adverse advents reported.

CT-P59 demonstrated it could contribute to both a reduced time to clinical recovery, as well as a reduced proportion of patients who progress to severe disease, said Professor Eom Joong-Sik, Infectious Disease Division at Gil Medical Center of Gachon University, who joined the clinical trial, emphasizing the drug is an essential treatment option to prevent progression of Covid-19.

With the positive Phase 2 trial data, the drug is more likely to be approved by health authorities this month as a second Covid-19 cure available in Korea following Gilead’s remdesivir.

Celltrion previously vowed to roll out the drug in Korea on a non-profit basis. It already completed production of the drug for the treatment of up to 100,000 patients. The company also plans to file for emergency use authorization of the drug in the U.S. and Europe this month. A Phase 3 trial is due with 720 Covid-19 patients globally.

By Kim Byung-ho, Kim Si-gyun and Minu Kim

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