Voyaging Toward a Cognitive Cure: New Data From Phase 1 Study of Revolutionary Oral Neurotherapeutic for Alzheimer’s & Parkinson’s

Viage Therapeutics’ DGX-001, an innovative oral therapeutic made to target the AVPR1A receptor in the gut, soared to incredible success after its Phase 1 study’s positive findings. It has a favorable safety profile and exciting proof of concept data that suggests the drug modulates the vagus nerve through receptor interactions on enteroendocrine cells in the gut, without the need to penetrate the blood brain barrier.

qEEG showed that the drug also caused brain activity changes in the subjects who trialed the drug, which has opened up the prospects of a Phase 2 development program to target mild cognitive impairment in multiple conditions, such as Alzheimer’s Disease and Parkinson’s Disease.

The Phase 1 study of DGX-001 in 68 healthy volunteers was a randomized, double-blind, placebo-controlled exploration of safety, tolerability, and pharmacokinetic effects from single and multiple ascending doses.

Those receiving the highest dose underwent a stress resilience panel to assess cognitive impairment in diseases like Alzheimer’s and Parkinson’s. This sleep-deprivation model provides a window into the effects of neurodegenerative diseases.

“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 drug candidate 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.”      

Phase 1 of the DGX-001 study demonstrated a safety profile that was well-tolerated, making it an appealing choice compared to most drugs approved for neuro-psychiatric treatment. Additionally, the drug’s gut-restricted system revealed promising signals of clinical activity, such as improving cognitive and executive functions, as evaluated through qEEG results.

These findings are in alignment with preclinical data, which also supports DGX-001’s intent to improve mood and cognitive function. Overall, the results of the study showcase DGX-001 as an exciting new treatment option with a favorable safety profile.

Viage Therapeutics was formerly known as Digestome Therapeutics and has attracted star investors from the US, China and Japan to back its daring Phase 2 program of DGX-001. DGX-001 is looking to revolutionize the landscape of cognitive health, developing the ultimate transdiagnostic approach that could expand far beyond the realms of neurology and psychiatry.

About Viage Therapeutics 

Viage Therapeutics, a neuroscience-focused company located in the San Francisco Bay Area, is pioneering a novel platform of neurotherapeutics, represented by its leading clinical stage candidate, DGX-001.

This first-of-its-kind oral drug seeks to modulate the activity of brain cells by targeting the vagus nerve through specific receptor interactions on enteroendocrine cells in the gut. Additionally, the Viage pipeline harnesses the possibilities of novel neuropeptides, second-generation DGX-001-derived peptides, and small molecules to take therapeutic progress further.

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