Synlogic (SYBX) Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1618 for the Treatment of Phenylketonuria

Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for SYNB1618 for the treatment of phenylketonuria (PKU). Previously, the U.S. Food and Drug Administration (FDA) granted SYNB1618 both Orphan Drug Designation and Fast Track designation.

“We are pleased that the EMA has issued a positive opinion for orphan designation for SYNB1618, in recognition of the urgent need for additional treatment options for PKU,” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “This designation reflects our constructive engagement with multiple regulatory agencies as we progress our PKU program into late-stage development. We look forward to advancing our PKU program into a registrational trial in the first half of 2023.”

About the European Medicines Agency Orphan Designation

The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the European Union (EU). Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

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