- – Information present dose-responsive, non-saturated will increase in gastrointestinal consumption of Phe in people by SYNB1618 -
– SYNB1618 Part 2 examine in sufferers with PKU ongoing with proof-of-concept readout anticipated in 2H 2021 –
– Part 1 examine of SYNB1934, an developed pressure of SYNB1618 within the PKU portfolio, initiated –
CAMBRIDGE, Mass., July 22, 2021 /PRNewswire/ — Synlogic, Inc. (Nasdaq: SYBX), a medical stage firm bringing the transformative potential of artificial biology to drugs, introduced at the moment the publication of two papers within the journals Nature Metabolism and Communications Biology. The publications element findings from a first-in-human examine of investigational Artificial Biotic™ drugs SYNB1618 and the event of a mechanistic mannequin to foretell the operate of an engineered bacterial therapeutic in wholesome volunteers and Phenylketonuria (PKU) sufferers. These knowledge add to the rising physique of scientific analysis demonstrating the therapeutic potential of Artificial Biotic™ medicines for the remedy of PKU.
“Our orally administered Artificial Biotic medicines are meant to deal with the wants of PKU sufferers of all ages and illness varieties by the consumption of phenylalanine (Phe) within the gastrointestinal tract. With two Phe-consuming strains now within the clinic, and a proof-of-concept readout in SYNB1618 anticipated within the second half of 2021, we stay up for advancing our PKU pipeline and growing a significant remedy for these residing with PKU,” mentioned Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Government Officer.
Key findings from the Nature Metabolism paper entitled, “Security and pharmacodynamics of an engineered E. coli Nissle for the remedy of phenylketonuria: a first-in-human Part 1/2a examine”:
On this first-in-human examine of a frozen liquid formulation of SYNB1618 in wholesome volunteers and sufferers with PKU, SYNB1618 was protected and properly tolerated, with no systemic toxicity and no proof of colonization. SYNB1618 was cleared inside 4 days of the final dose.
Dose-responsive will increase in strain-specific Phe metabolites in plasma and urine have been noticed, demonstrating SYNB1618 is ready to devour Phe and convert it to non-toxic metabolites within the GI tract of each wholesome volunteers and sufferers with PKU.
These knowledge show the potential to make use of engineered micro organism within the remedy of uncommon metabolic problems by the consumption of poisonous substances within the GI tract.
Concurrently, the event of a mechanistic mannequin predicting the potential for Phe-lowering efficacy in PKU sufferers was printed at the moment in Communications Biology. The paper, entitled, “Growth of a Mechanistic Mannequin to Predict Artificial Biotic Exercise in Wholesome Volunteers and Sufferers with Phenylketonuria,” used findings from the Part 1/2a examine to tell a mechanistic mannequin of pressure exercise in PKU sufferers.
Key findings embrace:
Development of a mechanistic mannequin that predicts SYNB1618 operate in non-human primates and wholesome topics is possible by combining in vitro simulations and prior information of human physiology.
The mannequin may be prolonged utilizing plasma Phe kinetics to PKU sufferers, informing medical growth of potential therapies for PKU.
Will increase in Phe removing from the GI tract are predicted to correlate strongly with discount of Phe within the blood.
The outcomes of this dose-response mannequin counsel Phe-consuming Artificial Biotic medicines comparable to SYNB1618 could have potential to realize clinically significant discount of blood phenylalanine ranges in sufferers with PKU.
Information on the stable oral formulation of SYNB1618 was introduced on the American School of Medical Genetics assembly in April 2021. Information on the event of SYNB1934, an developed pressure of SYNB1618, was introduced on the Artificial Biology: Engineering, Evolution & Design (SEED) convention in June 2021.
SYNB1618 continues to advance in a proof-of-concept Part 2 medical trial in adults with PKU, SynPheny-1 examine (NCT04534842), with knowledge anticipated within the second half of 2021. Study extra by visiting https:/
Phenylketonuria (PKU) is an inherited metabolic illness that manifests at beginning and is marked by an incapacity to interrupt down phenylalanine (Phe), an amino acid that’s generally discovered in lots of meals. Left untreated, excessive ranges of Phe turn out to be poisonous and may result in critical neurological and neuropsychological issues affecting the best way an individual thinks, feels, and acts. As a result of seriousness of those signs, infants are screened at beginning in lots of international locations to make sure early prognosis and remedy to keep away from mental incapacity and different problems.
About SYNB1618 and SYNB1934
SYNB1618 and SYNB1934 are investigational oral medicine for the remedy of Phenylketonuria (PKU) composed of an engineered Artificial Biotic designed to decrease plasma phenylalanine (Phe) ranges by consuming Phe within the GI tract. A stable oral lyophilized formulation of SYNB1618 was discovered to be protected and well-tolerated, and devour Phe within the GI tract of wholesome volunteers. Synlogic has initiated a Part 2 examine of SYNB1618 in PKU sufferers (NCT04534842) and a Part 1 examine of SYNB1934 in wholesome volunteers.
Synlogic™ is bringing the transformative potential of artificial biology to drugs. With a premiere artificial biology platform that leverages a reproducible, modular method to microbial engineering, Synlogic designs Artificial Biotic™ medicines that concentrate on validated underlying biology to deal with illness in new methods. Synlogic’s proprietary pipeline consists of Artificial Biotics for the remedy of metabolic problems together with Phenylketonuria (PKU) and Enteric Hyperoxaluria. The corporate can be constructing a portfolio of partner-able property in immunology and oncology.
This press launch accommodates “forward-looking statements” that contain substantial dangers and uncertainties for functions of the protected harbor offered by the Non-public Securities Litigation Reform Act of 1995. All statements, apart from statements of historic information, included on this press launch concerning technique, future operations, medical growth plans, future monetary place, future income, projected bills, prospects, plans and targets of administration are forward-looking statements. As well as, when or if used on this press launch, the phrases “could,” “might,” “ought to,” “anticipate,” “consider,” “estimate,” “anticipate,” “intend,” “plan,” “predict” and related expressions and their variants, as they relate to Synlogic could establish forward-looking statements. Examples of forward-looking statements, embrace, however should not restricted to, statements concerning the potential of Synlogic’s platform to develop therapeutics to deal with a variety of illnesses together with: most cancers, inborn errors of metabolism, and inflammatory and immune problems; our expectations about sufficiency of our present money stability; the longer term medical growth of Artificial Biotic medicines; the method Synlogic is taking to find and develop novel therapeutics utilizing artificial biology; and the anticipated timing of Synlogic’s medical trials of SYNB1618 and availability of medical trial knowledge together with Part 2 knowledge of SYNB1618 for the remedy of PKU. Precise outcomes might differ materially from these contained in any forward-looking assertion on account of numerous elements, together with: the uncertainties inherent within the medical and preclinical growth course of; the power of Synlogic to guard its mental property rights; and legislative, regulatory, political and financial developments, in addition to these dangers recognized underneath the heading “Threat Components” in Synlogic’s filings with the SEC. The forward-looking statements contained on this press launch replicate Synlogic’s present views with respect to future occasions. Synlogic anticipates that subsequent occasions and developments will trigger its views to alter. Nevertheless, whereas Synlogic could elect to replace these forward-looking statements sooner or later, Synlogic particularly disclaims any obligation to take action. These forward-looking statements shouldn’t be relied upon as representing Synlogic’s view as of any date subsequent to the date hereof.
SOURCE Synlogic, Inc.
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