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LONDON, UK / ACCESSWIRE / April 04, 2018 / Active-Investors.com has just released a free research report on Synlogic, Inc. (NASDAQ: SYBX). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=SYBX as the Company's latest news hit the wire. On April 02, 2018, the Company announced that the first patient was dosed in its Phase-1b/2a clinical study evaluating the safety and tolerability of SYNB1020, a novel, first-in-class, Synthetic Biotic medicine being developed for the treatment of hyperammonemia, associated with cirrhosis and urea cycle disorders (UCDs). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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The Company is likely to report top-line data from this trial by year-end 2018.
Synlogic is Evaluating SYNB1020 in Liver Disease Patients with Cirrhosis
Aoife Brennan, M.B., B.Ch., Chief Medical Officer at Synlogic, stated that the Company's recently reported Phase-1 trial of SYNB1020 demonstrated that this Synthetic Biotic medicine was well tolerated and provided a dose-dependent proof of mechanism, functioning as designed in healthy volunteers.
According to M. Brennan, Synlogic looks forward to evaluating the safety, tolerability, and therapeutic potential of SYNB1020 in patients with liver disease who have developed cirrhosis.
Synlogic Reported Positive Top-line Phase-1 Data for SYNB1020 for Treatment of Hyperammonemia
In November 2017, the Company announced positive top-line clinical data from its Phase-1 placebo-controlled single (SAD) and multiple ascending dose (MAD) clinical trial of SYNB1020 in healthy volunteers. The trial successfully met the primary objectives demonstrating safety and tolerability in healthy volunteers and identifying the maximum tolerated dose. Furthermore, proof of mechanism was demonstrated by a clear signal in a plasma nitrogen endpoint. These data supported the hypothesis that SYNB1020 treatment might provide clinical benefit in patients with UCDs or liver disease.
About Phase-1b/2a Trial of SYNB1020 in Patients with Cirrhosis
This Phase-1b/2a study has two parts:
First, an initial sentinel open-label cohort of subjects with cirrhosis and a MELD score < 12 will receive orally administered SYNB1020 for six days. Once safety and tolerability have been established in subjects, enrollment will be opened to subjects in Part 2;
Part 2 of the trial comprises a randomized, double-blinded, placebo-controlled study in patients with cirrhosis and hyperammonemia. Eligible subjects with an elevated ammonia level will proceed with randomization and receive either placebo or orally administered SYNB1020 for six days. The primary endpoint of the study is safety and tolerability. In addition, the study will evaluate the effect of SYNB1020 administration on plasma ammonia levels as well as other exploratory endpoints.
Hyperammonemia is a metabolic disturbance characterized by an excess of ammonia in the blood. It is a dangerous condition that may lead to brain injury and death. Increased entry of ammonia to the brain is a primary cause of neurologic disorders, such as congenital deficiencies of urea cycle enzymes, hepatic encephalopathies, Reye syndrome, and several other metabolic disorders. In healthy individuals, ammonia is primarily produced in the intestine as a byproduct of protein metabolism and microbial degradation of nitrogen-containing compounds. Ammonia is then converted to urea in the liver and is excreted in urine. However, if the liver's ability to convert ammonia to urea is compromised, either due to a genetic defect such as UCDs or acquired liver disease that leads to cirrhosis, ammonia accumulates in the blood.
SYNB1020 is a Synthetic Biotic medicine designed to remove excess ammonia from the blood. SYNB1020 operates from the gut microbiome and is engineered to activate a programmed metabolic pathway to remove excess ammonia for the treatment of UCD and other forms of hyperammonemia. By performing these metabolic activities, SYNB1020 may reduce abnormal levels of ammonia in the blood, compensating for defects in the intrinsic urea cycle.
In June 2016, Synlogic was granted Fast Track Designation from the US Food and Drug Administration (FDA) for SYNB1020 for the treatment of hyperammonemia in a group of UCDs.
About Synlogic, Inc.
Founded in 2014 and headquartered in Cambridge, Massachusetts, Synlogic is dedicated to bringing innovative medicines to patients by driving the convergence of two revolutionary fields: synthetic biology and the microbiome. The Company is pioneering the development of a novel class of living Synthetic Biotic medicines based on its proprietary drug discovery and development platform.
Stock Performance Snapshot
April 03, 2018 - At Tuesday's closing bell, Synlogic's stock dropped 2.21%, ending the trading session at $9.29.
Volume traded for the day: 43.39 thousand shares.
After yesterday's close, Synlogic's market cap was at $200.85 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.3% at the end of the session.
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