FDA Grants Fast Track Status To Synlogic's Rare Genetic Disorder Drug

Synlogic, Inc. SYBX announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate SYNB1353 for the potential treatment of homocystinuria (HCU).

SYNB1353 is currently being evaluated in a Phase 1 clinical study in healthy volunteers.

Aoife Brennan, President and Chief Executive Officer, stated, "The FDA's Fast Track designation reinforces our conviction for the urgent need for new treatments for HCU as well as the promising non-clinical data we have generated in the program to date.”

SYNB1353 is an engineered strain of the probiotic bacteria E. coli Nissle which consumes methionine within the gastrointestinal tract, preventing methionine absorption and conversion to homocysteine in plasma.

Synlogic holds worldwide development and commercialization rights to SYNB1353.

The company prepares to share results from the Phase 1 study of SYNB1353 in healthy volunteers by the end of 2022.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : Synlogic shares are trading around 2 percent at $1.01 on Tuesday during pre-market session.