FDA grants orphan drug designation to Synlogic Proprietary Synthetic Biotic
Release Date: 24-Nov-2016
Synlogic, a privately owned bio-pharmaceutical company focusing on developing novel medicines by synthetic biology and microbiome platform, announces that US Food and Drugs Administration grants its investigational program involving a live E. Coli Nissle bacterium modified to assimilate ammonia, for the treatment of urea cycle disorders (UCD). He company accounts for first Live E. Coli Nissle bacterium modified to assimilate ammonia for the potential treatment of UCDs.
UCDs are rare and severe genetic mutation allowing the build-up of toxic levels of ammonia in the bloodstream which causes severe neurological complications and even death. The synlogic’s leading candidate, SYNB1020, is currently undergoing clinical development. The company is planning to file another application for orphan drug status to FDA for its investigational new drug for treatment for UCDs.
The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.
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