SYNB 1618
Alternative Names: SYN PKU; SYNB-1618Latest Information Update: 29 Mar 2023
At a glance
- Originator Synlogic
- Class Probiotics
- Mechanism of Action Bacteria replacements; Gastrointestinal microbiome modulators
-
Orphan Drug Status
Yes - Phenylketonuria
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase II Phenylketonuria
- Discontinued Hyperoxaluria; Maple syrup urine disease
Most Recent Events
- 20 Mar 2023 Efficacy and adverse events data from a phase Synpheny-1 study in Phenylketonuria released by Synlogic
- 06 Jan 2023 Phase II developement in Phenylketonuria is still ongoing in USA (PO)
- 18 Oct 2022 Efficacy and adverse events data from a phase Synpheny-1 study in Phenylketonuria released by Synlogic
Development Overview
Introduction
SYNB 1618 is an engineered E. coli Nissle strain, being developed by Synlogic, for the treatment of phenylketonuria, maple syrup urine disease and enteric hyperoxaluria. This Synthetic Biotic™ medicine is a probiotic designed to convert phenylalanine into metabolites, including trans-cinnamic acid (TCA) in the blood, that can be further metabolised in the liver to generate hippuric acid, which is excreted in the urine. These candidates were built leveraging Synlogic’s capabilities to engineer probiotics to operate from within the microbiome and catabolise the primary metabolites which cause disease pathogenesis in urea cycle disorder and phenylketonuria. Phase II clinical development for phenylketonuria is underway in the US.
Preclinical development for the treatment of maple syrup urine disease and enteric hyperoxaluria was also underway in the US. However, as of January 2021, SYNB 1618 is no longer being developed for these indications and development in these indications is discontinued (Synlogic pipeline, January 2021).
Company Agreements
In November 2015, Synlogic in-licensed synthetic biology circuitry technology from Massachusetts Institute of Technology [1] .
Key Development Milestones
Phenylketonuria
In May 2022, European Medicines Agency (EMA) issued a positive opinion for orphan designation for SYNB 1618 in treatment of phenylketonuria [2] .
In March 2023, Synlogic announced that the primary endpoint was met successfully.In October 2022, Synlogic completed a phase II SynPheny-1 trial that evaluated the efficacy and safety of SYNB 1618 in patients with phenylketonuria (NCT04534842; SYNB1618-CP-003). The open label trial initiated in August 2020, enrolled 20 patients in the US [3] . Later, in September 2021, interim results from the trial were released by Synlogic [4] . In November 2021, Synlogic announced that it had added an additional arm to the trial to include a cohort of PKU patients treated with SYNB 1934 [see Adis Insight drug profile800063285]. In November 2021, interim efficacy and safety data from the trial released by Synlogic [5] . In October 2022, Synlogic released efficacy and adverse events data from the trial [6] .In March 2023, Synlogic released efficacy and adverse events data from the trial [7]
In July 2019, Synlogic completed a first-in-human, phase I/IIa trial evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy SYNB 1618 in healthy volunteers and patients with phenylketonuria (SYNB1618-CP-001; NCT03516487). The single and multiple ascending dose (SAD/MAD), randomised, double-blind, placebo-controlled, dose-escalation study enrolled 70 adult volunteers and patients in the US [8] . In April 2018, the company dosed the first patient in the trial [9] . The interim data from the healthy volunteers arm of the trial was released in September 2018 which met its primary point and dose for next phase of the trial was determined [10] . In July 2019, Synlogic released data for the trial. Full data from the trial were released in September 2019 [11] [12] [13] .
In September 2019, Synlogic initiated the bridging study in healthy volunteers with a new lyophilised formulation of SYNB 1618 to establish maximum tolerated dose (MTD) for efficacy study in patients with phenylketonuria. In addition to identifying a maximum tolerated dose of 2 x 1012 live cells (5.3 x 1011 colony forming units, or CFUs), the study demonstrated that a dose ramp improved SYNB1618 tolerability and that pH buffering was required for maximum Phe-consuming activity of the strain. In December 2019, the company presented data demonstrating the improved tolerability of lyophilised formulation of SYNB 1618 over early liquid formulation and guide to next clinical stage [14] [15] [16] [11] [17] . In April 2021, Synologic released the safety and pharmacodynamics data from this study [18] .
In April 2018, the US FDA granted Fast Track designation to SYNB 1618 (SYN PKU) for the treatment of phenylketonuria [19] .
In October 2017, the US FDA granted orphan drug designation to SYNB 1618 for the treatment of phenylketonuria [20] .
In May 2019, results from preclinical studies that evaluated solid formulation of SYNB 1618 in non-human primates were presented by Synlogic [21] .
Synlogic released preclinical data of SYNB 1618 for the treatment of phenylketonuria [22] [23] [24] [25] [26] .
Discontinued indications
Maple syrup urine disease
As of January 2021, SYNB 1618 is no longer being developed for maple syrup urine disease and development in this indication is discontinued (Synlogic pipeline, January 2021).
As of April 2020, preclinical development for the treatment of maple syrup urine disease is underway (Synlogic pipeline, April 2020).
Enteric hyperoxaluria
As of January 2021, SYNB 1618 is no longer being developed for enteric hyperoxaluria and development in this indication is discontinued (Synlogic pipeline, January 2021).
In January 2020, Synlogic reported that the company has advanced development of SYNB 1618 for the treatment of enteric hyperoxaluria, resulting due to excessive ingestion or absorption of oxalate from gastrointestinal tract [27] .
Financing Information
In April 2018, Synlogic announced a registered direct offering of common stock of gross proceeds of approximately $US30 million. The net proceeds will be used to fund two planned phase Ib/IIa trials of SYNB 1020 [see Adis Insight Drug profile 800049789], the activities in process development, formulation and toxicology as needed for subsequent initiation of a phase IIb trial in patients with liver cirrhosis with elevated blood ammonia, planned phase I/IIa trial of SYNB 1618 through completion and to support acceleration of a phase IIb trial of SYNB 1618 for phenylketonuria patients and continued process development and formulation activities and or the further preclinical development in its immuno-oncology programs and drug discovery activities in its other programs [28] .
In January 2018, Synlogic issued additional shares in the public offering of its common stock, with gross proceeds of approximately $US57.5 million. The net proceeds will be used to fund two planned phase Ib/IIa clinical trials of SYNB 1020 [see AdisInsight Drug profile 800049789], for the activities in process development, formulation and toxicology for subsequent initiation of a phase IIb clinical trial in liver cirrhosis with elevated blood ammonia. The funding will also be used to fund a planned phase I/IIa trial of SYNB 1618, and to support progress of a phase IIb trial of SYNB 1618, and to fund further preclinical development in immuno-oncology programs and drug discovery activities in its other programs [29] [30] [31] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Liquid, unspecified
- Class Probiotics
- Target Bacteria; Gastrointestinal microbiome
- Mechanism of Action Bacteria replacements; Gastrointestinal microbiome modulators
-
WHO ATC code
A16A (Other Alimentary Tract and Metabolism Products)
-
EPhMRA code
A16A (Other Alimentary Tract and Metabolism Products)
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
phenylketonuria |
Detailed Description |
L-Phenylalanine |
|
|
phenylketonuria |
Eligibility Criteria |
Prothrombin (PT) phenylalanine hydroxylase L-Phenylalanine Creatinine C-reactive protein (CRP) |
|
|
phenylketonuria |
Outcome Measure |
L-Phenylalanine |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| SYNB 1618 | C-reactive protein (CRP) | Eligibility Criteria |
| Creatinine | Eligibility Criteria | |
| L-Phenylalanine | Detailed Description, Eligibility Criteria, Outcome Measure | |
| phenylalanine hydroxylase | Eligibility Criteria | |
| Prothrombin (PT) | Eligibility Criteria |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Hyperoxaluria | Enteric hyperoxaluria | - | Discontinued (Preclinical) | USA | PO / unspecified | Synlogic | 15 Jan 2021 |
| Maple syrup urine disease | - | - | Discontinued (Preclinical) | USA | PO / unspecified | Synlogic | 15 Jan 2021 |
| Phenylketonuria | - | - | Phase II | USA | PO / unspecified | Synlogic | 25 Aug 2020 |
| Phenylketonuria | - | - | Phase I/II | USA (fast track) | PO / Liquid | Synlogic | 18 Apr 2018 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Phenylketonuria |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Phenylketonuria | - | USA | Synlogic | 24 Oct 2017 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Synlogic | Originator | USA |
| Synlogic | Owner | USA |
| Massachusetts Institute of Technology | Technology Provider | USA |
Scientific Summary
Pharmacokinetics
In the phase II SynPheny-1 trial in patients (N=8), results from an interim analysis showed that treatment with SYNB 1618 was associated with a 40% reduction in D5-Phe absorption after a meal challenge, a 20% reduction in mean fasting plasma Phe across all patients and a >250 µM mean reduction in fasting plasma Phe among responder subjects [5] . Earlier results from the phase II SynPheny-1 trial in patients (N=8) with phenylketonuria demonstrated meaningful reductions of phenylalanine (Phe) were reported which were consistent with prospective biomarker-driven modeling. In addition, treatment with SYNB 1618 demonstrated 20% reduction in fasting plasma Phe after 14 days of dosing, at a dose of 1e12 live cells; Fasting plasma Phe level began to trend down after seven days of dose titration, at a dose up to 3e11 live cells, and was statistically significant at the 1e12 dose at day 14. a 40% reduction in labeled plasma D5-Phe after meal challenge at day 15, at a dose of 2e12 live cells was also reported. There was a rebound of plasma Phe levels following cessation of dosing [3] [4] .
In a mouse model of phenylketonuria (Pah enu2/enu2) and healthy non-human primates (NHPs), oral administration of SYNB 1618 exhibited a dose-responsive pharmacokinetics as determined by production of hippuric acid (HA) in the urine [22] .
Adverse Events
Updated result from the phase II Synpheny-1 study showed that in SYNB 1618 treated group all adverse effects were mild to severe and mainly gastrointestinal in character, consistent with those of a probiotic. There were no significant adverse reactions (SAEs). Three participants in the trial left because of GI-related adverse events, one participant withdrew consent, and one participant left because of an adverse event of face flushing that was thought to be an allergic response [6] [3] . Earlier data in the phase II SynPheny-1 trial in patients (N=8) with phenylketonuria, treatment with SYNB 1618 was safe and also generally well tolerated, with no serious adverse events and a tolerability profile consistent with results from previous phase 1 studies. Adverse events were primarily GI related and mild to moderate in nature. There were no treatment drug related discontinuations [3] [4] [5] [7]
Results from the phase I/II trial demonstrated that SYNB 1618 was safe and well tolerated, with no systemic toxicity. Interim results from both single and multiple ascending dose studies demonstrated that no drug-related significant adverse events (SAEs) were reported. All AEs were mild-to-moderate in severity in both the SYNB 1618 treated and placebo groups and of the moderately severe AEs, nausea and vomiting were the most common. Only one participant in the highest dose cohort discontinued dosing. IN SAD portion 24 participants and in MAD portion 32 participants were enrolled in the study. Full results from the trial showed a complete absence of treatment-related serious adverse events (SAEs), with treatment-emergent AEs being mild or moderate in intensity. Most of these were GI-related, mild and reversible [13] [11] [10] [8] .
In phase I study, SYNB 1618 solid oral formulation was safe and well tolerated in healthy volunteers [18] [17] .
Pharmacodynamics
Summary
In an animal mouse model of phenylketonuria and healthy non-human primates (NHPs), oral administration of SYNB 1618 demonstrated significant decrease in lower blood phenylalanine levels and dose-dependent production of biomarkers, such as plasma TCA and urinary hippurate [23] .
In a mouse model of phenyl ketonuria (PKU), SYNB 1618 was effective at lowering blood phenylalanine from both the diet and from systemic phenylalanine. Blood phenylalanine lowering correlated with hippuric acid production in the urine of SYNB 1618 treated mice. SYNB 1618 also inhibited elevation of blood phenylalanine in healthy non-human primates (NHPs) following an oral phenylalanine dietary challenge and demonstrated drug-like dose response properties [24] .
Preclinical studies in a mouse models and non-human primates of phenylketonuria (PKU) demonstrated that oral administration of SYN PKU caused significant decrease in blood phenylalanine levels. Systemically delivering labelled phenylalanine to non-human primates resulted in excretion of labelled hippurate in the urine [25] . SYN PKU metabolised phenylalanine to produce trans-cinnamic acid (TCA) in both the mouse and the normal human primate, after being converted in vivo to hippuric acid. Plasma phenylalanine levels were also lowered by 49%, following subcutaneous administration of SYN-PKU in the enu2 mouse model of PKU [26] .
A solid formulation of SYNB 1618 indicated similar activity to frozen liquid in terms of consumption of phenylalanine or production of trans-cinnamic acid/hippuric acid in an in vitro gut simulation model and in vivo in non-human primates and a mouse model of disease. The product was stable for > 90 days at 2 - 8°C and > 30 days at room temperature [21] .
In a phase I/II trial, statistically significant increase in biomarkers of SYNB 1618 activity was noted in SYNB 1618 treated subjects but not in those treated with placebo [12] [8] .
In phase I study, SYNB 1618 solid oral formulation has been shown to be metabolically active in gastrointestinal tract in healthy volunteers. SYNB 1618 reduced the increase of plasma D5-Phe in a dose-dependent manner. Evidence of activity in the fasted state i.e. without protein intake was shown. This suggests an ability to metabolize non-dietary Phe in the gastrointestinal tract [18] [17] .
Therapeutic Trials
In a phase I/II trial, treatment with SYNB 1618 demonstrated dose-responsive increase in strain-specific phenylalanine (Phe) metabolites in plasma and urine, demonstrating SYNB 1618 capability to consume Phe and convert it to non-toxic metabolites. Clearance of SYNB 1618 was observed within four days of the last dose. In single- ascending dose (SAD) portion of the study the maximum tolerated dose (MTD) was 2 x 1011 CFU. A statistically significant dose-dependent increase in both plasma TCA and urinary HA was observed in SYNB 1618 treated participants. Production of metabolites from Phe administered as a free amino acid was similar to Phe administered as whole protein. In addition, production of metabolites was similar whether the protein was administered as a liquid or as a solid meal. In multiple ascending dose (MAD) portion also a statistically significant dose-dependent increase in plasma TCA and urinary HA was observed in SYNB 1618-treated participants but not in those treated with placebo. In healthy volunteers who had normal Phe metabolism, there was no impact on blood Phe levels. All healthy volunteers enrolled in the study cleared SYNB 1618 from their GI tracts. IN SAD portion 24 participants and in MAD portion 32 participants were enrolled in the study. Full results from the trial displayed a statistically significant increase in TCA and HA, in both healthy volunteers and patients treated with SYNB 1618, but not in placebo-treated patients, indicating that SYNB 1618 consumed phenylalanine in the human GI tract. Equivalent biomarker production and tolerability were seen in both patients and healthy volunteers at a dose of 7 x 1010 colony forming units (CFU). Data from volunteers also provided evidence of activity in the human GI tract of the second phenylalanine-consuming function engineered into SYNB 1618 (LAAD). Bacteria clearance in the expected time frame, occurred in all patients. Colonisation was not observed, and no patient required antibiotics [13] [11] [10] [8] .
In the phase II Synpheny-1 study data from individuals who took SYNB 1618 and SYNB 1934 while also taking sapropterin at baseline were included in the findings. Results were in line with the overall effectiveness profile in these patients, indicating the potential for adjunctive use. Response was outlined as a Phe decrease of more than 20% on either day 7 or day 14. In total, 60% of the participants who finished the study's dosage met these requirements (six of the ten patients dosed with SYNB 1618 and three of the five that have completed dosing with SYNB 1934 met this criterion). The overall average Phe decrease for those respondents was -42%. For SYNB 1618 and SYNB 1934, respectively, the Phe decrease ranges among respondents were -20% to -61% and -29% to -80%Updated results from the trial demonstrated plasma Phe reduction of -53% among responders (defined as >20% reduction in Phe from baseline). Patient taking Kuvan at baseline, achieved an additional reduction in plasma Phe of -80% compared to baseline [7] [6] [3]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Jun 2023 | Trial Update | Synlogic plans a pivotal phase III trial for Phenylketonuria in H1 2023 (700345544) [2] | 01 Jun 2022 |
| 31 Dec 2020 | Trial Update | Synlogic plans a phase II trial for Phenylketonuria (PO,Solid) in the second half of 2020 (700309698) [32] | 08 Sep 2020 |
| 31 Dec 2019 | Trial Update | Synlogic plans a bridging study with oral solid formulation (In volunteers) in Q3 of 2019 [12] | 09 Sep 2019 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 20 Mar 2023 | Scientific Update | Efficacy and adverse events data from a phase Synpheny-1 study in Phenylketonuria released by Synlogic [7] Updated 29 Mar 2023 |
| 06 Jan 2023 | Active Status Review | Phase II developement in Phenylketonuria is still ongoing in USA (PO) Updated 06 Jan 2023 |
| 18 Oct 2022 | Scientific Update | Efficacy and adverse events data from a phase Synpheny-1 study in Phenylketonuria released by Synlogic [6] Updated 12 Nov 2022 |
| 07 Oct 2022 | Trial Update | Synlogic completes a phase II SynPheny-1 trial in Phenylketonuria in USA (PO) (NCT04534842) Updated 29 Mar 2023 |
| 26 May 2022 | Regulatory Status | Synlogic receives positive opinion from the EMA for orphan drug designation for SYNB 1618 in Phenylketonuria [2] Updated 01 Jun 2022 |
| 26 May 2022 | Trial Update | Synlogic plans a pivotal phase III trial for Phenylketonuria in H1 2023 [2] Updated 01 Jun 2022 |
| 22 Nov 2021 | Scientific Update | Pharmacokinetics and adverse events data from the phase II Synpheny-1 trial in Phenylketonuria released by Synlogic [5] Updated 05 Dec 2021 |
| 20 Sep 2021 | Scientific Update | Interim pharmacokinetics and adverse events data from the Synpheny-1 phase II trial in Phenylketonuria released by Synlogic [4] Updated 22 Sep 2021 |
| 10 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 22 Jul 2021 | Scientific Update | Efficacy and adverse events data from a phase I/II trial in Phenylketonuria released by Synlogic [13] Updated 26 Jul 2021 |
| 13 Apr 2021 | Scientific Update | Adverse events and pharmacodynamics data from a phase I trial in Phenylketonuria (In volunteers) presented at American College of Medical Genetics 2021 (ACMG-2021) [18] Updated 15 Apr 2021 |
| 15 Jan 2021 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Hyperoxaluria in USA (PO) before January 2021 (Synlogic pipeline, January 2021) Updated 15 Jan 2021 |
| 15 Jan 2021 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Maple syrup urine disease in USA (PO) before January 2021 (Synlogic pipeline, January 2021) Updated 15 Jan 2021 |
| 25 Aug 2020 | Phase Change - II | Phase-II clinical trials in Phenylketonuria in USA (PO) (NCT04534842) Updated 15 Jan 2021 |
| 06 Aug 2020 | Trial Update | Synlogic plans a phase II trial for Phenylketonuria (PO,Solid) in the second half of 2020 [32] Updated 08 Sep 2020 |
| 07 Apr 2020 | Phase Change - Preclinical | Preclinical trials in Maple syrup urine disease in USA (PO), prior to April 2020 (Synlogic pipeline, April 2020) Updated 07 Apr 2020 |
| 01 Jan 2020 | Phase Change - Preclinical | Preclinical trials in Hyperoxaluria in USA (PO) [27] Updated 13 Jan 2020 |
| 04 Sep 2019 | Scientific Update | Full efficacy and adverse events data from a phase I/II trial in Phenylketonuria released by Synlogic [11] Updated 09 Sep 2019 |
| 04 Sep 2019 | Trial Update | Synlogic initiates a bridging study in Healthy volunteers (PO, Solid) before September 2019 [11] Updated 09 Sep 2019 |
| 25 Jul 2019 | Trial Update | Synlogic completes a phase I/II trial in Phenylketonuria in USA (NCT03516487) Updated 08 Aug 2019 |
| 15 Jul 2019 | Trial Update | Synlogic plans a bridging study with oral solid formulation (In volunteers) in Q3 of 2019 [12] Updated 09 Sep 2019 |
| 15 Jul 2019 | Scientific Update | Pharmacodynamics data from a phase I/II trial in Phenylketonuria released by Synlogic [12] Updated 17 Jul 2019 |
| 01 May 2019 | Phase Change | Early research in Phenylketonuria in USA (PO) before May 2019 [21] Updated 07 May 2019 |
| 01 May 2019 | Scientific Update | Pharmacodynamics data from a preclinical study in Phenylketonuria released by Synlogic [21] Updated 07 May 2019 |
| 01 Jan 2019 | Phase Change - I | Phase-I clinical trials in Phenylketonuria (In volunteers) in USA (PO) Updated 31 Dec 2019 |
| 06 Sep 2018 | Scientific Update | Interim safety and efficacy results from a phase I/II trial in Phenylketonuria released by Synlogic [10] Updated 06 Sep 2018 |
| 14 Aug 2018 | Scientific Update | Pharmacokinetics data from a preclinical trial in Phenylketonuria (PKU) released by Synlogic [22] Updated 20 Aug 2018 |
| 11 Jun 2018 | Scientific Update | Pharmacodynamics data from a preclinical trial in Phenylketonuria released by Synlogic [23] Updated 13 Jun 2018 |
| 25 Apr 2018 | Regulatory Status | SYNB 1618 receives Fast Track designation for Phenylketonuria [PO] in USA [19] Updated 30 Apr 2018 |
| 18 Apr 2018 | Phase Change - I/II | Phase-I/II clinical trials in Phenylketonuria in USA (PO) [9] Updated 24 Apr 2018 |
| 12 Mar 2018 | Scientific Update | Pharmacodynamics data from a preclinical trial in Phenylketonuria released by Synlogic [24] Updated 24 Apr 2018 |
| 23 Jan 2018 | Trial Update | Synlogic plans a phase IIb trial of SYNB 1618 for Phenylketonuria [31] Updated 24 Apr 2018 |
| 23 Jan 2018 | Trial Update | Synlogic plans a phase I/IIa trial of SYNB 1618 for Phenylketonuria [31] Updated 24 Apr 2018 |
| 24 Oct 2017 | Regulatory Status | SYNB 1618 receives Orphan Drug status for Phenylketonuria in USA [20] Updated 24 Apr 2018 |
| 24 Oct 2017 | Trial Update | Synlogic plans to file an investigational new drug application (IND) with the FDA for SYN B1618 for the treatment of Phenylketonuria in early 2018 [20] Updated 24 Apr 2018 |
| 07 Sep 2017 | Scientific Update | Pharmacodynamics data from a preclinical trial in Phenylketonuria released by Synlogic [25] Updated 24 Apr 2018 |
| 23 Mar 2017 | Scientific Update | Pharmacodynamics data from a preclinical trial in Phenylketonuria released by Synlogic [26] Updated 24 Apr 2018 |
| 29 Aug 2016 | Phase Change - Preclinical | Preclinical trials in Phenylketonuria in USA (PO) Updated 24 Apr 2018 |
| 01 Nov 2015 | Licensing Status | Synlogic in-licenses synthetic biology circuitry technology from Massachusetts Institute of Technology [1] Updated 26 Jun 2018 |
| 17 Sep 2015 | Phase Change | Early research in Phenylketonuria in USA (PO) Updated 24 Apr 2018 |
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-
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