The drug regulator recently refused to approve a local trial of Nature Cell’s Covid-19 treatment candidate Astrostem-V. In response, Nature Cell said it would not seek the nod again in Korea but instead focus on the U.S. trial.

In a public filing, Nature Cell said that the Ministry of Food and Drug Safety rejected its plan to conduct a phase-1/2a trial of Astrostem-V.

On Nov. 3, the company had sought approval for the local study to evaluate Astrostem-V’s safety and efficacy in patients with pneumonia caused by Covid-19 infection. The investigational drug was an autologous adipose tissue-derived mesenchymal stem cell therapy.

However, the ministry rejected the trial plan, citing insufficient data.

Nature Cell said it would not seek local approval for a local trial of Astrostem-V again.

The company plans to concentrate on the U.S. phase-1/2a study, approved by the FDA in August.

Winning the FDA’s nod for the U.S. trial has not been easy for Nature Cell, though.

Nature Cell submitted the Investigational New Drug (IND) application to the FDA in April. Still, the FDA placed the IND clinical hold in May due to insufficient information about Chemistry, Manufacturing, and Control (CMC). In August, the FDA lifted the clinical hold and granted the IND.

According to ClinicalTrials.gov, the U.S. phase-1/2a trial of Astrostem-V will recruit 10 patients. The study is expected to end on April 1, 2022, and the patient enrollment has yet to start.

Meanwhile, the Advanced Regenerative Bioindustry Act, which went into effect on Aug. 28, allows biotech companies to seek conditional approval for a stem cell therapy based on phase-2 data.

Daewoong Pharmaceutical has been conducting a phase-1 trial of DWP710, an autologous mesenchymal stem cell therapy, in Indonesia since July to see if it can treat Covid-19.

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