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Synlogic to abandon ammonia disorder therapy after trial failure

Synlogic Inc. is discontinuing developing its medicine SYNB1020 after the drug failed to lower ammonia levels in certain patients with a metabolic disorder in an early-stage trial.

The Cambridge, Mass.-based biopharmaceutical company's stock was down 28.99% to $3.43 as of 11:05 a.m. ET on Aug. 20.

Synlogic was evaluating SYNB1020 in a phase 1b/2a study in patients with cirrhosis and hyperammonemia, a metabolic condition in which there is an excess of ammonia in the blood. Cirrhosis is a late stage of scarring of the liver caused by certain forms of liver diseases and conditions.

The study evaluated the safety and tolerability of the drug, as well as changes in blood ammonia levels and several other goals associated with early-stage hepatic encephalopathy. A disorder caused by a buildup of toxins in the brain due to advanced liver disease, it affects a patient's behavior, mood and speech.

The trial had two parts. In the first part, six patients with cirrhosis received an oral dose of SYNB1020. In the second part, 17 patients with cirrhosis and hyperammonemia received either placebo or orally administered SYNB1020.

Synlogic said it decided to discontinue developing SYNB1020 after data from an interim analysis of the study showed no evidence of blood ammonia being lowered nor changes in other exploratory goals compared to placebo.

The company, however, noted that plasma and urinary nitrate increased in patients treated with the drug, indicating that the strain was active. SYNB1020 was also well tolerated in patients with cirrhosis.

"[We] are disappointed that results from our Phase 1b/2a study of SYNB1020 did not demonstrate an activity profile in ammonia lowering that warranted continued development of the program," Synlogic's President and CEO Aoife Brennan said.

Brennan added that the company will now focus its resources on advancing other new programs in early development. These include SYNB1618 to treat phenylketonuria a rare inherited disorder that causes the buildup of the amino acid phenylalanine — and SYNB1891 to treat solid tumors.