DGX-001 / Digestome Therap, Zhongze Therap - LARVOL DELTA

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Escalating Single and Multiple Doses of DGX-001 in Healthy Volunteers Followed by a Stress Exposure Resilience Panel (SERP) (CTAD 2023) - P1 | "DGX-001 is safe and well tolerated in healthy adults. The exploratory PD assessments suggested improved cognitive function and sleep quality following administration of DGX-001. DGX-001 will next be tested in a transdiagnostic phase 2 study to determine its ability to alleviate cognitive impairment observed in patients with Alzheimer’s, Parkinson’s, or depression. ."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Gastroenterology • Gastrointestinal Disorder • Insomnia • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder • Xerostomia

Viage Therapeutics announces data from a Phase 1 study with DGX-001, a first-in-class oral neurotherapeutic targeting cognitive impairment in patients with Alzheimer's Disease and Parkinson's Disease (PRNewswire) - P1 | N=68 | NCT05121831 | Sponsor: Viage Therapeutics | "Viage Therapeutics...today announced positive findings from its Phase 1 study of DGX-001...DGX-001 demonstrated both a favorable safety profile and proof of concept data relating to its mechanism of action (MoA), which modulates the vagus nerve via specific receptor interactions on enteroendocrine cells in the gut, with no systemic exposure of the drug and no need to penetrate the blood brain barrier....These results support the initiation of a Phase 2 development program targeting mild cognitive impairment in multiple indications including Alzheimer's Disease (AD), and Parkinson's Disease (PD)....The key findings from the Phase 1 study demonstrate that DGX-001 has a favorable safety profile and is well-tolerated."

New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Parkinson's Disease

A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001 (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Digestome Therapeutics | Recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Nov 2022

Trial completion • Trial completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001 (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Digestome Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2022 ➔ Mar 2023

Enrollment open • Trial completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry