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 andParkinson’s Disease- DGX-001 demonstrates changes in brain activity as measured by quantitativeelectroencephalography (qEEG), supporting a mechanism of action based on AVPR1Adependent modulation of the gut-brain axis
- Company to initiate a Phase 2 proof-of-concept development program initially targeting
mild cognitive impairment due to Alzheimer’s Disease and Parkinson’s Disease
San Francisco, US – July 26, 2023
Viage Therapeutics (Viage), a neuroscience company based on a platform of novel
neurotherapeutics, today announced positive findings from its Phase 1 study of DGX-001, a
first-in class oral therapeutic targeting the AVPR1A receptor in the gut. 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. The MoA is supported by the observation of brain activity changes, as measured
by qEEG, in the subjects dosed with DGX-001. These results support the initiation of a Phase 2development program targeting mild cognitive impairment in multiple indications including
Alzheimer’s Disease (AD), and Parkinson’s Disease (PD).
The Phase 1 study was a randomized, double-blind, placebo-controlled, safety, tolerability andpharmacokinetic study of single ascending and multiple ascending doses (MAD) of DGX-001 in68 healthy volunteers. Subjects who received the highest dose in the MAD cohort also
underwent a stress exposure resilience panel, which is based on a sleep-deprivation model
believed to mimic cognitive impairment in patients with neurodegenerative diseases (like ADand PD).
The key findings from the Phase 1 study demonstrate that DGX-001 has a favorable safety
profile and is well-tolerated. Following oral dosing, DGX-001 is not systemically detectable,because it’s gut-acting and gut-restricted, which supports the advantageous safety profile,particularly compared to most approved neuro-psychiatric drugs which suffer from numerous
side effects. DGX-001 showed potential signals of clinical activity, including its potential to
improve cognitive and executive functions, as measured through qEEG changes. Overall, theseclinical results are consistent with preclinical data also indicating DGX-001’s gut-restrictedmechanism of action and its efficacy in models of mood and cognitive function.
“Results from the Phase 1 study provide a compelling safety profile and support further
exploration of the therapeutic potential of DGX-001 in cognitive disorders,” commented Titus
Plattel, President of Viage Therapeutics. “We are excited to make our first-in-class oral drugcandidate available to patients as we initiate the Phase 2 clinical program and in parallel discuss
steps to file an investigational new drug application with the FDA.”
Viage Therapeutics, formerly known as Digestome Therapeutics, is backed by investors fromthe US, China and Japan. The Phase 2 program of DGX-001 will initially aim to achieve cognitive
improvement across different diseases, representing a transdiagnostic study design, which may
ultimately enable indications beyond neurology and psychiatry.
About Viage Therapeutics
Viage Therapeutics is a neuroscience-focused company based on a platform of novel
neurotherapeutics. DGX-001, Viage’s lead clinical stage candidate, represents a first-in-classoral drug candidate targeting the gut-brain axis. The proposed mechanism of action of DGX-001
is to modulate the vagus nerve through specific receptor interactions on enteroendocrine cells
in the gut, resulting in a regulation of brain cell activity. Viage’s pipeline is comprised of bothnovel neuropeptides and 2nd generation DGX-001-derived peptides and small molecules. The
Company is headquartered in the San Francisco Bay Area.
Company Contact:
Titus Plattel, MSc., MBA
Titus@Viagetx.com