FDA Grants Synlogic’s SYNB1353 Fast Track Status for Homocystinuria

The FDA has granted Synlogic Therapeutics’ experimental drug SYNB1353 a Fast Track designation as a potential treatment for homocystinuria — an inherited disorder marked by high levels of an amino acid called homocysteine.

The elevated amino acid levels can lead thromboembolism, lens dislocation, skeletal abnormalities, developmental delay and intellectual disability.

Preclinical data has shown that SYNB1353 lowered levels of blood homocysteine in non-human primates and mice, and the Cambridge, Mass., company plans to share phase 1 clinical trial results evaluating the drug in healthy patients by year’s end.

An engineered strain of the probiotic bacteria E. coli Nissle, SYNB1353 works by consuming methionine within the gastrointestinal tract, blocking methionine absorption and conversion to homocysteine in plasma. The drug was developed through a research pact between Synlogic and Boston, Mass.-based Ginkgo Bioworks.

FDA’s Fast Track designation permits drugmakers more frequent meetings with FDA officials to discuss clinical trial design, development plans and the data needed to support a drug approval, in addition to granting sponsors eligibility to pursue rolling applications and receive a Priority Review.