Translate Bio Announces FDA Clearance to Proceed with a Single-ascending Dose (SAD) Phase 1/2 Clinical Trial for Ornithine Transcarbamylase (OTC) Deficiency
Telesis Bio, Inc. (TBIO)
US:NASDAQ Investor Relations:
businesswire.com/news/home/20170630005160/en/precipio-diagnostics-transgenomic-complete-merger
Company Research
Source: GlobeNewswire
LEXINGTON, Mass., June 26, 2019 (GLOBE NEWSWIRE) -- Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a single-ascending dose (SAD) Phase 1/2 clinical trial of MRT5201 in adult patients with ornithine transcarbamylase (OTC) deficiency. MRT5201 is a first-in-class treatment designed to directly address the underlying cause of OTC deficiency by providing mRNA encoding the fully functional OTC enzyme in patients with the disease. “We are very pleased to be able to move forward with this first-in-human clinical trial of MRT5201 in patients with OTC deficiency,” said Ronald Renaud, chief executive officer, Translate Bio. “This represents a significant milestone for our team as we advance our second mRNA therapeutic for t
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