SYNB1934 / Synlogic - LARVOL DELTA

Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) (clinicaltrials.gov) - P3 | N=40 | Terminated | Sponsor: Synlogic | N=150 ➔ 40 | Trial completion date: Oct 2027 ➔ Mar 2024 | Suspended ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Feb 2024; Based on a review of early data from participants in the dose escalation phase, it was determined that SYNB1934v1 is unlikely to meet the study's primary endpoint for lowering phenylalanine (Phe) levels in patients.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Metabolic Disorders • Phenylketonuria • Rare Diseases

Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) (clinicaltrials.gov) - P3 | N=150 | Suspended | Sponsor: Synlogic | Recruiting ➔ Suspended

Trial suspension • Metabolic Disorders • Phenylketonuria • Rare Diseases

Efficacy and safety of a synthetic biotic for treatment of phenylketonuria: a phase 2 clinical trial. (PubMed, Nat Metab) - P2 | "We previously modified Escherichia coli Nissle 1917 to metabolize Phe in the gut after oral administration (SYNB1618) and designed a second strain (SYNB1934) with enhanced activity of phenylalanine ammonia lyase. Four participants discontinued because of adverse events, and one withdrew during the baseline period. We show that synthetic biotics can metabolize Phe in the gut, lower post-prandial plasma Phe levels and lower fasting plasma Phe in patients with PKU."

Journal • P2 data • Infectious Disease • Metabolic Disorders • Phenylketonuria • Rare Diseases

Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Synlogic | Not yet recruiting ➔ Recruiting

Enrollment open • Metabolic Disorders • Phenylketonuria • Rare Diseases

Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Synlogic

New P3 trial • Metabolic Disorders • Phenylketonuria • Rare Diseases

Robust performance of a live bacterial therapeutic chassis lacking the colibactin gene cluster. (PubMed, PLoS One) - "Deletion of pks also had no effect on the activity of strains engineered to degrade phenylalanine (SYNB1618 and SYNB1934) or oxalate (SYNB8802). Importantly, there was no significant difference on in vivo strain performance between the clinical-stage strain SYNB1934 and its isogenic Δpks variant with regards to recovery of the quantitative strain-specific biomarkers d5- trans-cinnamic acid, and d5-hippuric acid. Taken together, these data support that the pks island is dispensable for Synthetic Biotic fitness and activity in vivo and that its removal from engineered strains of EcN will not have a deleterious effect on strain efficacy."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SynPheny-1: Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Synlogic | Recruiting ➔ Completed

Trial completion • Metabolic Disorders • Phenylketonuria • Rare Diseases

Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=106 | Completed | Sponsor: Synlogic | Recruiting ➔ Completed

Trial completion

SynPheny-1: Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Synlogic; N=12 ➔ 24

Clinical • Enrollment change • Metabolic Disorders • Phenylketonuria • Rare Diseases

Improvement of a synthetic live bacterial therapeutic for phenylketonuria with biosensor-enabled enzyme engineering. (PubMed, Nat Commun) - "A lead enzyme candidate from this screen is used in the construction of SYNB1934, a chromosomally integrated strain containing the additional Phe-metabolizing and biosafety features found in SYNB1618. Head-to-head, SYNB1934 demonstrates an approximate two-fold increase in in vivo PAL activity compared to SYNB1618."

Journal • Gastrointestinal Disorder • Metabolic Disorders • Phenylketonuria • Rare Diseases