FDA lifts clinical hold on Translate Bio's targeted mRNA candidate
Massachusetts, USA-based messenger RNA (mRNA) specialist Translate Bio says the US Food and Drug Administration has cleared the company to begin a first-in-human clinical trial of MRT5005 in patients with cystic fibrosis.
MRT5005 is an mRNA therapeutic candidate that is designed to treat patients with cystic fibrosis by addressing the underlying cause of the disease.
The FDA had reportedly requested more detailed information for the drug related to chemistry, manufacturing and controls (CMC), delaying the green light for a few months. The company now says it intends to start dosing patients in a Phase I/II clinical trial in mid-2018.
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