South Korean-based Celltrion has posted positive data for its investigational COVID-19 targeting monoclonal antibody (mAb) from a phase 2/3 study.
The first portion of the phase 2/3 study of the mAb, CT-P59, enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups.
Participants were randomised to receive either CT-P59 40 mg/kg, CT-P59 80mg/kg or placebo.
Within this patient population, approximately 60% of patients with moderate symptoms also suffered from COVID-19-related pneumonia.
At day 28, patients treated with Celltrion’s mAb demonstrated a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality.
In comparison to placebo, CT-P59 treated patients who had mild-to-moderate COVID-19 experienced a 54% reduction in the risk of progressing to severe COVID-19.
For patients with moderate COVID-19, this reduction was even higher, at 68%.
In the CT-P59 treatment groups, patients also demonstrated a significantly shortened time to clinical recovery – ranging from 3.4 to 6.4 days faster than patients in the placebo group.
In addition, CT-P59 treated patients also ‘rapidly and significantly’ reduced viral load through day seven of treatment compared to placebo.
“Our top-line data from the global phase 2/3 clinical trial has demonstrated that CT-P59 is effective for the treatment of COVID-19 in mild-to-moderate patients and especially in moderate patients aged 50 years and over,” said HoUng Kim head of medical and marketing division at Celltrion Healthcare.
“We are encouraged by the robust and consistent nature of the top-line clinical profile of CT-P59 and our clinical studies are on track in more than ten countries,” he added.
Celltrion identified CT-P59 as a potential treatment for COVID-19 by screening antibody candidates and choosing ones which demonstrated the highest potency in neutralising SARS-CoV-2, the virus which causes COVID-19.
Pre-clinical data for the mAb demonstrated a 100-fold reduction in viral load of the novel coronavirus, in addition to a reduction in lung inflammation.
In September, Celltrion also announced interim results from a phase 1 clinical trial of CT-P59, which showed a promising safety, tolerability and pharmacokinetics profile for the drug.
In this early phase study, CT-P59 also demonstrated no significant drug-related adverse event, and there were also no adverse events from the maximum tolerated dose cohort.