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신로직, 'SYNB1020' 효능 입증 실패.."임상 중단" - 바이오스펙테이터

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신로직, 'SYNB1020' 효능 입증 실패.."임상 중단"

입력 2019-08-22 06:55 수정 2019-08-24 17:17

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간부전, 간경변 환자 대상 임상1b/2a상서 증상 악화 확인

프로바이오틱스를 이용해 합성 생물의약품을 개발하는 미국 신로직(Synlogic)은 ‘SYNB1020’ 임상1b/2a상(NCT03447730)에서 고암모니아혈증(hyperammonemia) 환자의 증상이 개선되지 않아 임상시험을 중단한다고 20일(현지시간) 발표했다.

신로직의 임상시험 중단 발표 이후, 신로직의 주가는 4.83달러에서 20일 3.32달러로 31% 폭락했다.

고암모니아혈증은 간이 손상돼 암모니아 대사가 정상적으로 작동되지 않는 환자에게서 발생한다. 혈중암모니아 수치가 높아지면 뇌를 손상시켜 간성뇌증(hepatic encephalopathy)을 유발한다. 급성 간부전(acute liver failure) 환자의 사망률은 80%에 달하는데 급성 간부전 환자의 주요 사망 원인은 간성뇌증으로 인한 뇌부종이다.

신로직은 병원성이 없는 대장균인 EcN(Escherichia coli strain Nissle)을 이용해 질병 치료를 시도하고 있다. 이번에 임상시험 중단을 발표한 SYNB1020은 고암모니아혈증을 치료하기 위해 개발된 유전자변형 EcN이다. EcN에는 암모니아를 아르기닌(arginine)으로 변환하는 대사과정이 있다. 신로직은 아르기닌 생성을 억제하는 효소가 만들어지지 않도록 EcN의 유전자를 변형해 SYNB1020을 개발했다.

신로직은 SYNB1020을 23명의 간부전, 간경변(cirrhosis) 환자에게 투여한 임상1b/2a상에서, 혈중암모니아 수치를 낮추지 못했다. 오히려 환자의 혈중암모니아가 증가하는 부작용을 발견했으며, 초기 단계의 간성뇌증을 확인했다. 이번 임상1b/2a상에 대한 자세한 결과는 향후 학회에서 발표될 예정이다.

이퍼 브레난(Aoife Brennan) 신로직 CEO는 "임상1b/2a상에서 SYNB1020 투여로 암모니아를 낮추지 못한 결과에 실망했다"고 말했다. 이어서 "자사의 파이프라인인 페닐케톤뇨증(phenylketonuria, PKU) 대상 ‘SYNB1618’, 고형암 대상 ‘SYNB1891’ 및 초기 단계에 있는 프로그램을 개발하는 것에 집중할 것"이라고 강조했다.

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