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SYNB1934 (labafenogene marselecobac) is an orally administered, non-systemically absorbed, PheP & mPAL stimulant. It is being developed for the treatment of phenylketonuria.
Lead Product(s): Labafenogene Marselecobac
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2024
Details:
Science 37 will provide virtual clinical trial technology and services for Synpheny-3, Synlogic's ongoing pivotal, Phase III trial of investigational drug SYNB1934 (labafenogene marselecobac) as a potential treatment for phenylketonuria, a rare, genetic metabolic disorder.
Lead Product(s): Labafenogene Marselecobac
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Science 37 Holdings
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 11, 2023
Details:
SYNB1934 is an orally administered, non-systemically absorbed drug candidate being studied as potential biotherapeutic for the treatment of phenylketonuria (PKU), receives Fast Track Designation from FDA.
Lead Product(s): Labafenogene Marselecobac
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2023
Details:
SYNB1934 is an orally administered, non-systemically absorbed drug candidate being studied as potential biotherapeutic for the treatment of phenylketonuria (PKU), receives orphan drug designation from FDA.
Lead Product(s): SYNB1934
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2023
Details:
SYNB1353 is a novel orally-administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract thereby lowering homocysteine levels in patients with homocystinuria (HCU).
Lead Product(s): SYNB1353
Therapeutic Area: Genetic Disease Product Name: SYNB1353
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2022
Details:
The new candidate, SYNB2081, is a Synthetic Biotic and is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo, following investigational new drug candidate SYNB1353 for the potential treatment of homocystinuria.
Lead Product(s): SYNB2081
Therapeutic Area: Rheumatology Product Name: SYNB2081
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ginkgo Bioworks
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
Preclinical in vivo and in vitro studies demonstrated a greater than 2-fold improvement in the ability of SYNB1934 to consume and break down Phe compared to SYNB1618, based on production of Phe metabolites.
Lead Product(s): SYNB1934
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Details:
Data from preclinical in vivo and in vitro studies demonstrated a greater than 2-fold improvement in the ability of SYNB1934 to metabolize Phe compared to SYNB1618.
Lead Product(s): SYNB1934
Therapeutic Area: Genetic Disease Product Name: SYNB1934
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
The company announced Progression of a proof of concept Phase 2 clinical trial of SYNB1618 for the treatment of Phenylketonuria (PKU). A solid oral formulation of SYNB1618 has been shown to metabolize Phe in the GI tract in a healthy volunteer study.
Lead Product(s): SYNB1618
Therapeutic Area: Genetic Disease Product Name: SYNB1618
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
SYNB8802 is a Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria. Poster titled "In silico Simulation to Predict Activity of a Synthetic Biotic, SYNB8802, in Healthy Volunteers and Patients with Enteric Hyperoxaluria" will be presented at the conference.
Lead Product(s): SYNB8802
Therapeutic Area: Gastroenterology Product Name: SYNB8802
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
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