SAN FRANCISCO, March 8, 2022 – Digestome Therapeutics, a biotech company developing first-in-class therapeutics that stimulate the central nervous system (CNS) via the gut-brain-axis, announced that the first patient has been enrolled in a Phase 1 clinical trial investigating DGX-001. The trial will feature safety as the primary endpoint and will also investigate a variety of biomarkers to assess the biological and clinical response to DGX-001.
DGX-001 is a first-in-class oral, vagus nerve stimulating therapeutic being initially developed for the treatment of negative symptoms and cognitive impairment in patients with schizophrenia, and for non-motor symptoms in patients with Parkinson's Disease. The innovative drug is gut-acting and gut-restricted. It acts on the CNS via the vagus nerve, thereby modulating parasympathetic activity and inflammation in the body.
"We are excited to bring DGX-001 forward into the clinic. This represents significant clinical milestone for Digestome and our first-in-class gut-brain-axis therapeutic platform," said Ken Horne, President of Digestome Therapeutics. "This is an important first step towards helping negative symptoms and cognitive impairment in schizophrenia patients, as well as non-motor symptoms in Parkinson's Disease patients. Over 60% of schizophrenia patients have clinically significant negative symptoms, and over 70% of Parkinson's patients have clinically significant non-motor symptoms. There are no approved therapies for such schizophrenia patients and these patients' symptoms go largely untreated. DGX-001's unique pharmacology and mechanism of action are particularly well suited for these indications," continued Mr. Horne.
The trial is anticipated to be completed in the fourth quarter of 2022.
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