VT-5006 / Vertero Therapeutics - LARVOL DELTA

Topic #9: Can gut-mediated therapeutics dampen the neuroinflammatory response in pre-clinical animal mod (WPC 2026) - "Remarkably, oral administration of AX-5006 potently reverses existing motor symptoms in multiple behavioral tests in a PD mouse model and also clears aSyn aggregates from the brains of mice. Built on innovative concept and basic research studies, our long-term goal is to unravel the pathophysiology of PD and develop breakthrough interventions that target the gut, rather than the more challenging prospect of delivering therapeutics to the brain."

Preclinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammation • Movement Disorders • Parkinson's Disease

Talk #3 Gut-mediated therapeutics in preclinical models (WPC 2026) - "Remarkably, oral administration of AX-5006 potently reverses existing motor symptoms in multiple behavioral tests in a PD mouse model and also clears aSyn aggregates from the brains of mice. Built on innovative concept and basic research studies, our long-term goal is to unravel the pathophysiology of PD and develop breakthrough interventions that target the gut, rather than the more challenging prospect of delivering therapeutics to the brain."

Preclinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

VT-5006 oral therapy advances into Phase 1b testing for Parkinson’s disease (Parkinson's News Today) - "The first participant has been dosed in Vertero Therapeutics’ Phase 1b clinical trial testing VT-5006, an investigational, gut-directed oral small molecule being developed for Parkinson’s disease...The Phase 1b clinical trial (NCT07310264) is still recruiting adults ages 40-80 with early- or moderate-stage Parkinson’s who were diagnosed within the past 10 years, at one site in the Netherlands. This follows the completion of the first part of the trial in healthy volunteers, which found no significant safety or tolerability signals, according to the company....It will initially enroll 24 participants, who will be randomly assigned to receive VT-5006 at a low or high dose or placebo daily for 28 days."

Trial status • Parkinson's Disease

AXL-5006-101: Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Vertero Therapeutics

First-in-human • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

AXL-5006-101: Research into the safety of a new agent (AX-5006) in people with and without Parkinson's disease. (clinicaltrialsregister.eu) - P1 | N=84 | Recruiting | Sponsor: Vertero Therapeutics Inc.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Vertero Therapeutics

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Vertero Initiates Phase 1 Study of VT-5006, A Selective Small Molecule Therapy for Parkinson’s Disease (The Manila Times) - "The Phase 1a portion of the study is enrolling healthy volunteers to receive VT-5006 either as a single dose or once daily for seven days."

Trial status • Parkinson's Disease

DEVELOPMENT OF AX-5006, A SMALL MOLECULE INHIBITOR OF CSGA AGGREGATION AS A POTENTIAL DISEASE-MODIFYING TREATMENT FOR PARKINSON'S DISEASE (ADPD 2024) - "AX-5006 is a small molecule inhibitor of bacterial CsgA aggregation in the gut. Efficacy data in the ASO mouse model as well as its pharmacokinetic profile support AX-5006 as a novel development candidate. IND-enabling nonclinical studies are underway, and a clinical study is anticipated to begin in 2024."

CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

Axial Therapeutics Receives Second Research Grant Award from The Michael J. Fox Foundation to Further Support Advancement of AX-5006 for Parkinson’s Disease (GlobeNewswire) - "The funding will support further preclinical development to assess the therapeutic efficacy of AX-5006, a small molecule, gut-restricted amyloid inhibitor for symptomatic treatment and modification of disease in Parkinson’s disease (PD). IND-enabling studies of AX-5006 are ongoing to support initiation of a Phase 1 clinical trial in 2024."

Financing • New P1 trial • CNS Disorders • Parkinson's Disease