Synlogic Clinical Trials
Clinical trials test potential therapies in human volunteers, both healthy individuals and patients affected by specific diseases, to assess the safety and effectiveness of a potential new treatment. Clinical trial volunteers are critical to advancing research and finding new therapies. Synlogic clinical studies are collaborative efforts between us, our partner clinical research organizations, and leading physicians and health care providers around the world.
Currently, Synlogic has clinical trials underway in the following areas:
PKU Clinical Trial
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 then leads to severe neurological disorders and developmental delays. SYNB1618 is an oral investigational Synthetic Biotic medicine designed to break down Phe in the GI tract, potentially reducing plasma Phe levels or allowing patients to consume higher amounts of natural protein, improving their quality of life[AG1] [CB2] . To date, we have determined that SYNB1618 can effectively break down phenylalanine in the GI tract of both healthy volunteers and patients. Now, Synlogic has initiated a Phase 2 study in PKU patients called SynPheny-1 (NCT04534842) to see if SYNB1618 can decrease Phe levels in the blood.
For more information about the study and potential participation, visit the study website https://pkuresearchstudy.com or contact Kendall Davis, Manager of Patient Advocacy and Engagement at PRA Health Sciences. Kendall can be reached at Kendall@PRAHS.com.
Cancer Clinical Trial
Cancer cells have long been masters at evading our immune system — allowing these dangerous cells to proliferate and metastasize. Immunotherapies, such as antibodies to upregulate the immune system, are increasingly used to harness the patient’s own immune system against the tumor, but only a minority of patients respond to these therapies. SYNB1891 is an investigational Synthetic Biotic medicine that is delivered intratumorally or within a tumor via injection and aims to activate the immune system. Synlogic has initiated a Phase 1 clinical study of intratumorally-administered SYNB1891 in patients with advanced solid tumors and lymphoma. To learn more about this trial (NCT04167137), click here.
Enteric Hyperoxaluria Trial
Enteric Hyperoxaluria (HOX) is a well-known complication of multiple bowel conditions, including inflammatory bowel diseases, bariatric/weight-loss surgery, short bowel syndrome, and others. The disorder, which is caused by the over-absorption of oxalate in the GI tract, results in dangerously high urinary oxalate levels, damaging the kidneys. Recurrent kidney stones, chronic kidney disease, and nephrocalcinosis (hardening of the kidney due to toxic calcium oxalate crystal deposits) may result. There are currently no approved therapies for Enteric Hyperoxaluria. SYNB8802 is an oral investigational Synthetic Biotic medicine designed to break down oxalate in the GI tract, lower levels of oxalate in the urine, and potentially reduce the risk for related kidney damage.
Synlogic is conducting a Phase 1a/b clinical study to evaluate the safety, tolerability, and potential for urinary oxalate lowering of SYNB8802 in healthy volunteers and patients. The study has two parts: Part A is a multiple ascending dose study in healthy volunteers; Part B is a placebo controlled, cross-over design study in patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery.
To date, we have demonstrated that SYNB8802 has achieved proof of mechanism in healthy volunteers during Part A of the study. Now, Synlogic has initiated Part B of the study in patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery. For more information about the study (NCT04629170) and potential participation, click here.