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Data support the lead clinical program in urea cycle disorders (UCD) and the further development of Synthetic Biotic™ candidates as potential treatments for phenylketonuria (PKU) and maple syrup urine disease (MSUD)
Synlogic (NASDAQ: SYBX) announced the presentation of new preclinical data from programs investigating the company’s novel Synthetic Biotic drug candidates at the 13th International Congress of Inborn Errors of Metabolism (ICIEM), which is being held in Rio de Janeiro, Brazil, September 5-8, 2017.
The data, generated in mouse and non-human primates, demonstrate that Synlogic’s Synthetic Biotic medicines are active in the gastrointestinal (GI) tract and are able to break down both dietary and systemic sources of metabolites that build to toxic levels in patients with UCD, PKU and MSUD.
“These data demonstrate that our Synthetic Biotic medicines can act from the GI tract to potentially reduce the build-up of toxic metabolites throughout the body in each of these disorders,” said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. “There is a huge need for improved treatment options for many Inborn Errors of Metabolism (IEMs), and we believe that orally administered living Synthetic Biotic medicines could provide a promising option for patients.”
Development of Genetically Engineered E. coli Nissle Strains for the Treatment of Phenylketonuria and Maple Syrup Urine Disease – Oral Presentation, Abstract number 248.
A Genetically Engineered E. coli Nissle to Prevent Hyperammonemia in Urea Cycle Disorder (UCD) – Poster Presentation, Abstract number 377.
About SYNB1020 and SYNB1618
Earlier this year, Synlogic initiated a Phase 1 clinical trial in healthy volunteers designed to evaluate the safety and tolerability of its lead compound, SYNB1020, as a potential treatment for UCD. Pending the success of this first study, Synlogic plans to initiate two additional clinical trials with the investigational candidate in symptomatic patients with urea cycle disorders (UCD) or hepatic encephalopathy (HE), both conditions in which patients experience elevated and toxic blood ammonia levels. In the first half of 2018, the company also plans to initiate a clinical trial with SYNB1618, a synthetic biotic medicine designed to treat phenylketonuria (PKU), which is caused by defective metabolism of the amino acid phenylalanine.
About Synthetic Biotic™ Medicines
Synlogic’s innovative new class of Synthetic Biotic™ medicines leverages the tools and principles of synthetic biology to genetically engineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s two lead programs target a group of rare metabolic diseases – inborn errors of metabolism (IEM). Patients with these diseases are born with a faulty gene, inhibiting the body’s ability to break down commonly occurring by-products of digestion that then accumulate to toxic levels and cause serious health consequences. When delivered orally, these medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect. Synthetic Biotic medicines are designed to clear toxic metabolites associated with specific metabolic diseases and have the potential to significantly improve symptoms of disease for affected patients.
Synlogic™ is pioneering the development of a novel class of living Synthetic Biotic™ medicines based on its proprietary drug discovery and development platform. Synlogic’s initial pipeline includes Synthetic Biotic medicines for the treatment of rare genetic diseases, such as Urea Cycle Disorder (UCD) and Phenylketonuria (PKU). In addition, the company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of other diseases, such as liver disease, inflammatory and immune disorders, and cancer. Synlogic is collaborating with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease (IBD). For more information, please visit synlogictx.com.
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic’s platform to develop therapeutics to address a wide range of diseases including UCD, PKU and MSUD, the future clinical development of SYNB1020 and its prospects as a potential treatment for hyperammonemia, the future development of other product candidates, such as SYN-PKU and SYN-MSUD and the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, the uncertainties inherent in the preclinical development process, the ability of Synlogic to protect its intellectual property rights and legislative, regulatory, political and economic developments.
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