Posted by Michael Wonder on 26 Apr 2018
Synlogic receives fast track designation for SYNB1618, a synthetic biotic medicine for the treatment of phenylketonuria
25 April 2018 - Phase 1/2a clinical study of SYNB1618 evaluating safety and tolerability as well as exploratory endpoints expected to report interim data in 2018.
Synlogic announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical product candidate, SYNB1618. SYNB1618 is an oral, investigational medicine designed to metabolize phenylalanine as a treatment for phenylketonuria (PKU).
Synlogic has dosed the first subjects in a Phase 1/2a clinical trial of SYNB1618 to evaluate safety and tolerability, as well as exploratory endpoints in both healthy volunteers and patients with PKU, from which the company expects to report interim data in 2018.
