News-20220308

-------From the Digestome's Press Release-------

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 of 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. DGX-001 has been developed based on the research done by Dr. Kousaku Ohinata at Kyoto University to discover functional peptides from various food proteins.

“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.

Digestome recently completed a $10M Seed financing to support the trial and further develop the therapeutic platform.

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