VVP808-002 Clinical Study
Verva’s leading product candidate, VVP808, is a non-thiazolidinedione insulin sensitizer for use in the treatment of type 2 diabetes mellitus (T2DM). Verva is currently undertaking a phase 2a clinical proof-of-concept study of VVP808 at multiple sites in Australia. Complete top-line clinical data are expected by the end of May, 2012.
The VVP808-002 clinical trial is a randomized, placebo-controlled, double-blinded study evaluating the safety and efficacy of VVP808 in T2DM patients who are (i) not taking any other glucose modulating medications; or (ii) currently stable on metformin alone. Participants will receive oral VVP808 or placebo daily for 24 weeks. The primary efficacy endpoint of the study will be a reduction in HbA1c levels in participants receiving VVP808 compared to those receving placebo. Secondary endpoints include fasting blood glucose; HOMA-IR index; and improvement in participant risk factors, including body weight, waist circumference, blood pressure and lipid profile. The main side-effect reported for VVP808 in its approved indication has been metabolic acidosis, which is dose-dependent and reversible. Participants in the VVP808-002 clinical study will be closely monitored for potential acidosis and other safety parameters.
Physicians and potential participants interested in learning more about the VVP808-002 clinical study may contact Verva’s clinical trial manager:
Ms Kathy Skoff
+61 (409) 596 088
kskoff@vervapharma.com
About VVP808
VVP808, is a non-thiazolidinedione insulin sensitizer for use in the treatment of type 2 diabetes mellitus (T2DM). VVP808 was identified from a library screening process using Verva’s proprietary Gene Expression Signature technology. VVP808 has a mode-of-action that appears to be different to existing diabetes medicines, providing an important new line of treatment for T2DM. Verva preclinical studies have demonstrated that VVP808 can reduce body weight and body fat in diabetic and obese mice. If this effect is reproduced in clinical testing, VVP808 will provide a value-added health benefit to diabetes patients beyond glucose control.
Diabetes Discovery Programs
Novel Insulin Sensitizing Target
Verva preclinical studies have determined that the mechanism by which VVP808 exerts its effect on blood glucose levels is different to its mode-of-action in its approved indication. Verva has a dedicated program to identify the biological target(s) through which VVP808 exerts its insulin sensitizing effects. Success in the VVP808-002 clinical trial will partially validate the relevance of this target in diabetes and its utility in diabetes drug development.
VVP100X
Verva is utilizing mechanistic and structural knowledge derived from studies with VVP808 and the target identification program to develop proprietary next-generation insulin sensitizers with improved efficacy and safety relative to current therapies. Preliminary in silico and in vitro studies identified 5 potential new development scaffolds and Verva has an on-going medicinal chemistry program to identify proprietary NCEs as potential insulin sensitizers.
GES Platform
Verva’s diabetes assets and technologies are the result of a decade of research acknowledging that type 2 diabetes is a multifactorial disease with different causes and diverse patient etiologies. Central to the diabetes effort is the Gene Expression Signature (GES) technology, which measures changes in expression of a critical selection of genes that are modulated when diabetic cells are rendered “normal” by treatment with anti-diabetic medications. Medium-to-longer term value-generation for Verva will be achieved by application of different GES types to identify medications that are optimised to groups of diabetic patients with different underlying diabetes pathologies. This “genomics-driven, personalised medicine” may lead to safer, more effective diabetes therapies.