Melbourne, Australia (06 June 2012). Verva Pharmaceuticals Ltd. (“Verva” or the “Company”) announced the top-line results of the recently-completed VVP808-002 Phase 2 clinical proof-of-concept study with the Company’s insulin sensitizer VVP808 (methazolamide). The clinical study achieved its protocol-specified primary efficacy endpoint, a reduction in the diabetes marker HbA1c compared to placebo after 24 weeks of treatment. The drug was safe and well-tolerated and the study identified potential additional clinical benefits of VVP808 beyond HbA1c reduction. Complete clinical data remain confidential and will be presented at a major diabetes conference in due course.
Verva also announced the results of its Annual General Meeting, held at the offices of Middletons Lawyers in Melbourne on 28 May 2012. Verva financial statements were noted and the current status, progress and strategy of the Company were elaborated in presentations by Verva’s Board chair Dr. Ian Nisbet and CEO Dr. Vince Wacher. Shareholders elected Dr. Peter Devine and Dr. Steve Gourlay to Verva’s Board of Directors and re-elected Professor Michael Cowley. There were no other resolutions for shareholder approval.
Further details from the AGM, including the Chairman’s address and CEO’s report (including more clinical details), are available on the Verva Pharmaceuticals website http://www.vervapharma.com/investors/notices-and-reports/
Verva's lead clinical product VVP808 is a non-thiazolidinedione, non-PPAR-modulating insulin sensitizer. The active ingredient of VVP808 (methazolamide) was originally approved in North America over 50 years ago as a treatment for glaucoma. Its unexpected anti-diabetic activity was identified using Verva's proprietary Gene Expression Signature (GES) discovery platform. In preclinical studies, VVP808 also demonstrated additional benefits such as weight and fat loss and increased glucose-lowering efficacy in combination with metformin (Konstantopoulos N et al. (2012) Methazolamide is a New Hepatic Insulin Sensitizer that Lowers Blood Glucose In Vivo. Diabetes published ahead of print May 14, 2012, doi:10.2337/db11-0578).
The VVP808-002 clinical trial was a multi-centre, randomized, double-blinded, placebo-controlled clinical proof-of-concept study evaluating the safety and efficacy of VVP808 (methazolamide) in patients with Type 2 diabetes. The VV808-002 clinical trial initially enrolled participants who were not treated with any diabetes medication (naïve) but was expanded to include participants who had been treated with first-line therapy metformin for at least 3 months and had been stable on their current metformin dose for at least 8 weeks prior to study entry.
Study participants received a single dose level of VVP808 (40 mg twice daily) or placebo in identical product presentations for 24 weeks. The primary efficacy endpoint of the clinical trial was a reduction in HbA1c from baseline in the pooled (naïve + metformin) VVP808 group vs. pooled placebo group after 24 weeks of treatment. The primary safety endpoint was the incidence of acidosis based on venous blood gas parameters. Secondary endpoints included the proportion of participants achieving HbA1c targets of =6.5% and =7.0% after 24 weeks, along with changes from baseline in fasting blood glucose, bodyweight, lipids, blood pressure, eGFR, microalbumin and hematology, biochemistry and urinalysis parameters. The study was powered to demonstrate superiority of pooled (naive + metformin) VV808 over pooled placebo for the primary efficacy endpoint.
A total of 76 participants were randomized to the study. Mean ± SD baseline HbA1c was 7.1 ± 0.7 in the VVP808 group (n=37; 15 naïve and 22 metformin-treated) and 7.4 ± 0.6 in the placebo group (n = 39; 20 naïve and 19 metformin-treated). Five participants withdrew from each of the VVP808 and placebo treatment groups. The number of adverse events was not different between VVP808 and placebo treated participants and there were no drug-related serious adverse events.
Verva Pharmaceuticals Ltd. is a virtually-operating, clinical-stage pharmaceutical company developing novel therapies to treat diabetes and obesity. In addition to VVP808, Verva's pipeline includes: (i) a program to elucidate the molecular target responsible for the VVP808 glucose lowering effect; (ii) a drug discovery program (VVP100X) developing next-generation insulin sensitizers based on VVP808 structure and mode-of-action; (iii) preclinical proof-of-concept with two obesity-focused technologies that block de novo fat formation; and (iv) the GES diabetes discovery and diagnostic platform. Further information can be found on the company’s website www.vervapharma.com.
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