Diabetes mellitus is a metabolic disorder characterized by abnormally high blood glucose levels due to inappropriate levels or action of insulin. The health consequences of uncontrolled diabetes are dramatic, including blindness, kidney dysfunction, and deteriorating leg/foot sores that may ultimately lead to amputation. Type 2 diabetes mellitus (T2DM) is the most common form of diabetes and current estimates project that 221 million adults worldwide will suffer T2DM by 2010. Current anti-diabetic drugs constitute a USD 16 billion global market; however, many marketed products suffer from limited long-term efficacy and/or significant side-effects. As such, there remains a compelling need for new T2DM therapies with improved safety and efficacy.
VVP808 Clinical Program
Verva’s leading product candidate, VVP808, is an insulin sensitizer for use in the treatment of 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 that may be used to complement – and hopefully supplant – existing drug therapies. Moreover, Verva preclinical studies have found that VVP808 reduces food intake and body weight in diabetic and obese mice. If this effect is reproduced in clinical testing, VVP808 will have a significant advantage over current and developmental T2DM drugs which are, at best, weight neutral and more commonly cause weight gain.
Verva is currently undertaking a phase 2a clinical proof-of-concept study of VVP808 at 3-sites in Victoria, Australia. 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 otherwise drug naive. 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.
Potential participants interested in learning more about the VVP808-002 clinical study may call the study coordinator in their area:
Barwon Health/Geelong Hospital: (03) 5226 7884
Eastern Health/Box Hill Hospital: (03) 9094 9523
Austin Health/Heidelberg Repatriation Hospital: (03) 9496 4026
Diabetes Discovery Programs
Verva is utilizing mechanistic and structural knowledge derived from studies with VVP808 to develop proprietary next-generation insulin sensitizers with improved efficacy and safety relative to current therapies.
To diversify our portfolio and expand our therapeutic range, we are developing screens to identify novel small molecule insulin secretion modulators for use in diabetes patients whose pancreatic cells do not produce sufficient insulin.
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.