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ENGINEERED WITH PURPOSE
Synlogic is delivering the power of synthetic biology to medicine, combining the precision of engineering with rational drug development. With a premiere synthetic biology drug discovery engine that leverages a reproducible, modular approach to microbial engineering, we design Synthetic Biotics to treat disease in new ways.
Synthetic biology brings engineering principles to science and enable the design of entirely new biological systems, genetic circuits and molecular components that can be used to create medicines that can have a meaningful impact for patients.
The Path to Possibilities
Starting in the 1960s, advancements in the scientific
understanding of how molecular networks regulate cellular
function and how gene expression is regulated within cells laid
the foundation for synthetic biology. Further catalyzed by
advances in molecular biology tools and DNA sequencing, these
findings led to a new era in biology where genetic toggles,
feedback circuits, and other tools made it possible to “program” bacterial cells in much the same way we program computers
to perform different functions.
With the completion of the landmark Human Genome Project in
2003, scientists had access to new insights about the genetic
causes of disease. The 2000s were also the first-time bacteria
were successfully reprogrammed to carry out specific functions, including attacking cancer cells and producing biofuel.
Synlogic was founded in 2014 as the first synthetic biology
company entirely focused on development of new therapeutics
based on the principles of synthetic biology, leading to a new therapeutic modality known as Synthetic Biotics.
Driving Progress for Patients
Unlocking the potential of Synthetic Biotics to treat different diseases begins with biology. From metabolic diseases where we design bacteria to play a precise therapeutic role in the gastro-intestinal (GI) tract to immunomodulation where our novel science and approach is built on advances in the understanding of the interaction between bacteria and the immune system, Synlogic is using established techniques and principles in synthetic biology as a technology to design medicines.
The Synlogic Approach:
Designing Synthetic Biotics
Synlogic is pioneering the development and use of Synthetic Biotics in medicine. Our platform combines deep synthetic biology expertise with an innovative manufacturing approach and translational ingenuity to build a pipeline of first-in-class biotherapeutics based on precision genetic engineering of well-characterized probiotics to deliver therapeutic benefit. We begin with an advanced understanding of molecular biology, microbial engineering and disease physiology. From there, our proprietary library of innovative tools and modular components includes state-of-the art metabolic gene circuitry and regulatory genetic switches that activate the medicine in its intended environment. Our platform rapidly produces bacterial microbes designed to perform specific therapeutic functions.
Metabolic Disease
Synlogic has produced multiple clinical-stage drug candidates that offer novel, oral, non-systemically administer approaches to serious diseases caused by an underlying metabolic disorder. The Synthetic Biotic approach is particularly well suited to these metabolic diseases, in which the disease–specific metabolites transit through the GI tract, providing validated targets for consumption.
Phenylketonuria or PKU
Patients living with PKU are not able to break down the phenylalanine amino acid (Phe) that is found in many foods, including vegetables, breads, and cereals. The buildup of Phe can cause severe neurological disorders and developmental delays. Labafenogene marselecobac (SYNB1934) is an orally administered, non-systemically absorbed drug candidate designed by engineering a probiotic to consume Phe in the GI tract. Labafenogene marselecobac is currently being studied in the global, pivotal Phase 3 study, Synpheny-3. Labafenogene marselecobac has received Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and orphan designation by the European Medicines Agency (EMA).
Homocystinuria (HCU)
Homocystinuria (HCU) is a rare metabolic disease that is caused by an inborn error of metabolism, specifically the loss of function of the enzyme cystathionine beta-synthase, which results in excessive accumulation of homocysteine and its metabolites in the blood and urine. People with HCU face risks of complications including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Many patients are required to comply with a rigid methionine-restricted diet and currently approved treatment options for HCU are limited due to efficacy and tolerability. In November 2021, Synlogic announced SYNB1353, an orally-administered, non-systemically absorbed drug candidate. SYNB1353 was designed using genetic engineering to program the probiotic bacteria E. coli Nissle (EcN) to consume methionine within the gastrointestinal tract, thereby preventing methionine absorption and conversion to homocysteine in plasma. Synlogic holds worldwide development and commercialization rights to SYNB1353, which is designed to consume methionine, a precursor to homocysteine, in the GI tract. The goal of treatment in HCU is to lower and control levels of total homocysteine (tHcy). SYNB1353 was granted Fast Track and Orphan Drug Designation by the FDA and is the first drug candidate developed through a research collaboration between Synlogic and Ginkgo Bioworks and the first investigational medicine developed on Ginkgo’s platform to enter the clinic. SYNB1353 has achieved proof of mechanism in a Phase 1 study using a dietary model of homocystinuria in healthy volunteers.
Enteric Hyperoxaluria
Enteric hyperoxaluria is a chronic, progressive disease characterized by high levels of urinary oxalate, a well-recognized cause of recurrent kidney stones. Some foods are high in oxalate such as green vegetables, coffee and chocolate. The buildup of oxalate crystallizes in the kidneys, causing crystal and stone formation. Oxalate crystals can damage kidneys, potentially leading to damage that can include nephrocalcinosis, chronic kidney disease (CKD) and end-stage renal disease (ESRD). Enteric hyperoxaluria often occurs as a result of a primary insult to the bowel, such as inflammatory bowel disease or short bowel syndrome, or as a result of surgical procedures such as Roux-en-Y bariatric weight-loss surgery. Currently, there are no approved FDA treatment options. SYNB88802 is a drug candidate designed to consume dietary oxalate throughout the GI tract, preventing its absorption. SYNB8802 has demonstrated proof of mechanism through a Phase 1a study in healthy volunteers using a dietary model of hyperoxaluria and it achieved proof of concept through positive and clinically significant lowering of urinary oxalate in a Phase 1b study in patients with a history of gastric bypass surgery.
Gout
Gout is a complex form of inflammatory arthritis that occurs when extra uric acid in the body forms crystals in the joints. It includes symptoms such as intense joint pain, inflammation and redness, and limited range of motion in the affected joints. Current treatment options present limitations in both safety and efficacy, highlighting a need for new approaches. In addition, gout is a recognized risk factor in chronic kidney disease (CKD). SYNB2081 is a Synthetic Biotic designed to lower uric acid, as a potential treatment of gout. This is Synlogic’s second drug candidate developed through its partnership with Ginkgo Bioworks.
Inflammatory Bowel Disease
Inflammatory bowel diseases (IBD) such as Crohn’s disease or ulcerative colitis result in chronic inflammation in the intestinal tract driven by an over activation of the immune system. These diseases can lead to severe health problems, resulting in debilitating abdominal pain and GI distress and often requiring invasive surgical interventions. Current therapies based on systemic immunosuppression fail to induce and maintain long-term remission in most patients. Synlogic is working to develop Synthetic Biotic medicines able to suppress the overactive immune response to improve the leakiness of the GI tract lining and reduce the signs and symptoms of IBD.