SYNB1353 / Synlogic - LARVOL DELTA

Conquering homocystinuria with engineered probiotics. (PubMed, Cell Host Microbe) - "In this issue, Perreault and colleagues present evidence that orally delivered engineered probiotic Escherichia Coli Nissle SYNB1353 is a promising candidate in reducing homocysteine, with successful trials in mice, monkeys, and humans. However, further probiotic optimization and safety assessments are required."

Journal • Metabolic Disorders

The live biotherapeutic SYNB1353 decreases plasma methionine via directed degradation in animal models and healthy volunteers. (PubMed, Cell Host Microbe) - "A phase 1 clinical study conducted in healthy volunteers subjected to an oral methionine challenge demonstrates that SYNB1353 is well tolerated and blunts plasma methionine by 26%. Overall, SYNB1353 represents a promising approach for methionine reduction with potential utility for the treatment of HCU."

Journal • Preclinical • Gastrointestinal Disorder • Metabolic Disorders

HCU: Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Synlogic | Recruiting ➔ Completed | N=64 ➔ 31 | Trial completion date: Jun 2023 ➔ Nov 2022 | Trial primary completion date: Mar 2023 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Metabolic Disorders

Current and Novel Therapeutical Approaches of Classical Homocystinuria in Childhood With Special Focus on Enzyme Replacement Therapy, Liver-Directed Therapy and Gene Therapy. (PubMed, J Clin Med Res) - "This review focus on present and new therapeutical approaches like the role of enzyme replacement with presentation of different novel targets in research like pegtibatinase, pegtarviliase, CDX-6512, erymethionase, chaperones, proteasome inhibitors and probiotic treatment with SYNB 1353. Furthermore, we analyze the role of liver-directed therapy with three dimensional (3D) bioprinting, liver bioengineering of liver organoids in vitro and liver transplantation. The role of different gene therapy options to treat and cure this extremely rare disease in childhood will be discussed."

Gene therapy • Journal • Review • Cardiovascular • Gene Therapies • Hepatology • Metabolic Disorders • Myocardial Infarction • Peripheral Arterial Disease • Rare Diseases • Transplantation

Methionine Restriction Prevents Cystine Urolithiasis in a Mouse Model of Cystinuria (KIDNEY WEEK 2022) - "Bladder weight in 12 mice maintained on low methionine diet averaged 5.7-11.0 mg. Conclusion Overall, these data indicate that methionine restriction prevents stone formation in Slc3a1 KO mice and SYNB1353 may offer a viable approach for the treatment of cystinuria."

Preclinical • Gastrointestinal Disorder • Metabolic Disorders • Renal Calculi • Urolithiasis

HCU: Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Synlogic | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Metabolic Disorders

HCU: Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Synlogic

New P1 trial • Metabolic Disorders