News & Articles

Verva Pharmaceuticals - Biotech Australia

Verva Announces Results of Annual General Meeting

Melbourne, Australia (06 June, 2014).  Verva Pharmaceuticals Ltd. (“Verva” or the “Company”) is pleased to announce the results of its Annual General Meeting (AGM), held at the offices of K&L Gates in Melbourne, Australia, on 30 May 2014.

Verva’s current status, progress, challenges and strategy were elaborated in a presentation by Verva’s Board chair Dr. Ian Nisbet. Verva shareholders approved all resolutions presented at the AGM, electing Dr. Cherrell Hirst, Dr. Joshua Funder and Professor Michael Cowley to Verva’s Board of Directors and approving the appointment of Hock C. Ching as the Company’s auditor to replace previous auditors Ernst & Young.

About Verva
Verva Pharmaceuticals Ltd. is a clinical-stage pharmaceutical company developing novel therapies to treat diabetes and related complications. Verva’s lead clinical molecule, VVP808, has completed a successful clinical proof-of-concept study in type 2 diabetes, where twice-daily dosing of VVP808 for 24 weeks reduced HbA1c relative to placebo and provided additional clinical benefits including weight loss and improved markers of liver function (ALT reduction).  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 GES discovery platform.

Mechanistic studies have determined that VVP808 is a new type of insulin sensitizer with a mode-of-action distinct from other diabetes therapies and different to its mode-of-action in glaucoma. VVP808 also reduced liver fat in animal models of diabetes, highlighting a potential application of VVP808 in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Verva’s pipeline includes a focused program to elucidate the molecular target responsible for the VVP808 effect in diabetes and a drug discovery program developing next-generation insulin sensitizers (termed VVP100X) based on VVP808 structure and mode-of-action.

Contact
Vince Wacher, CEO
vwacher@vervapharma.com
Australia: +61 (448) 871 479
USA:      +1 (760) 271-4783

Verva Announces 2014 Annual General Meeting

Melbourne, Australia (08 May 2014). Verva Pharmaceuticals Ltd. (”Verva”; ACN 074 636 847) is pleased to announce that the Annual General Meeting of Verva shareholders will be held on Friday 30 May, 2014 at 10:30 am in the offices of K&L Gates LLP, Level 25, 525 Collins Street, Melbourne, Victoria, Australia.

The Notice of Meeting and Proxy form for the AGM have been mailed to shareholders and are available on-line. Verva’s Annual Report for the year ending 31 December 2013, including audited financial statements, is also available on the Verva website (Verva 2013 Annual Report). A hard copy is available upon request.

In response to enquiries from a number of shareholders, Verva has also implemented a system by which Verva ordinary shareholders may surrender their shares for no consideration, thereby removing themselves as Verva shareholders.  Details and the required form are available at Verva Share Surrender Facility.

Verva Announces Grant of United States Patent for Type 2 Diabetes Therapy VVP808 and Results of Annual General Meeting

Melbourne, Australia (04 June, 2013).  Verva Pharmaceuticals Ltd. (“Verva” or the “Company”) is pleased to announce the grant of United States patent No. 8,455,432, entitled “Insulin Sensitizers and Methods of Treatment”, incorporating claims for the use of VVP808 (methazolamide) - alone or in combination with metformin - as a treatment for type 2 diabetes.

”The grant of a US patent is a significant achievement for the Company”, said Verva’s Board chair, Dr. Ian Nisbet.  “We are delighted to add a US patent to our growing portfolio of diabetes assets.“

Verva also announced the results of its Annual General Meeting (AGM), held at the offices of K&L Gates in Melbourne, Australia, on 31 May 2013.  Verva’s current status, progress, challenges and strategy were elaborated in presentations by Verva’s Board chair Dr. Ian Nisbet and CEO Dr. Vince Wacher.  Highlights of the last 12 months include:

• Completion of a sophisticated metabolomic study supporting Verva’s proposed VVP808 diabetes target and initiation of focused technical programs to confirm the VVP808 target hypothesis;

• Clinical and preclinical data supporting a potential application of VVP808 and analogues (VVP100X) in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) - a significant and growing unmet medical need and potentially multi-billion dollar market; and

• Positive feedback on Verva diabetes programs from discussions with potential partners worldwide.

Verva Shareholders approved all three resolutions presented at the AGM, re-electing Dr. Katherine Nielsen and Dr. Ian Nisbet to Verva’s Board of Directors and approving a Convertible Note financing of up to AUD 500,000.  Participation in the Convertible Note financing is available to all current Verva shareholders who meet the definition of “Wholesale Investor” (a person for whom the Company is not required to provide a disclosure document under Chapter 6D of the Corporations Act 2001) and is offered on a pro rata basis to the participants’ current Verva shareholding.  A description of Convertible Note terms and an Expression of Interest form were included with the AGM Notice of Meeting mailed to shareholders and are also available on-line.  Expressions of Interest must be returned to the Company by 07 June 2013.

Further details of these resolutions, along with the Chairman’s address and the CEO’s report, are available on the Verva Pharmaceuticals website.

About Verva:
Verva Pharmaceuticals Ltd. is a clinical-stage pharmaceutical company developing novel therapies to treat diabetes and related complications.  Verva’s lead clinical molecule, VVP808, has completed a successful clinical proof-of-concept study in type 2 diabetes, where twice-daily dosing of VVP808 for 24 weeks reduced HbA1c relative to placebo and provided additional clinical benefits including weight loss and improved markers of liver function (ALT reduction).  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 GES discovery platform.  Preclinical studies have determined that VVP808 is a new type of insulin sensitizer with a mode-of-action distinct from other diabetes therapies and different to its mode-of-action in glaucoma.  Recent preclinical data have also demonstrated that VVP808 reduces liver fat in animal models of diabetes, highlighting a potential application of VVP808 in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Verva’s pipeline includes a focused program to elucidate the molecular target responsible for the VVP808 effect in diabetes and a drug discovery program developing next-generation insulin sensitizers (termed VVP100X) based on VVP808 structure and mode-of-action.  Further information can be found on the Company’s website www.vervapharma.com.

Contact:
Vince Wacher, CEO
vwacher@vervapharma.com
Australia: +61 (448) 871 479
USA:      +1 (760) 271-4783

Verva Announces 2013 Annual General Meeting

Melbourne, Australia (10 May 2013). Verva Pharmaceuticals Ltd. (”Verva”; ACN 074 636 847) is pleased to announce that the Annual General Meeting of Verva shareholders will be held on Friday 31 May, 2013 at 9:00 am in the offices of K&L Gates LLP, Level 25, 525 Collins Street, Melbourne, Victoria, Australia.

The Notice of Meeting and Proxy form for the AGM have been mailed to shareholders and are available on-line. Verva’s Annual Report for the year ending 31 December 2012, including audited financial statements, is also available on the Verva website (Verva 2012 Annual Report). A hard copy is available upon request.

Verva Annual Report for 2012 Available On-line

Melbourne, Australia (30 April 2013).  Verva Pharmaceuticals Ltd. (“Verva” or the “Company”) is pleased to report that the annual report for 2012, including audited financials,  is available on the Company’s website at http://www.vervapharma.com/wp-content/uploads/2009/05/verva-2012-annual-report.pdf.  Verva’s financial year runs from 01 January to 31 December.

About Verva
Verva Pharmaceuticals Ltd. is a virtually-operating, clinical-stage pharmaceutical company developing novel therapies to treat diabetes and related complications.  Verva’s clinical molecule, VVP808, has completed a successful clinical proof-of-concept study in type 2 diabetes, where twice-daily dosing of VVP808 for 24 weeks reduced the key diabetes marker HbA1c and provided additional clinical benefits including weight loss and improved markers of liver function.  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.

Verva Announces Results of Successful VVP808-002 Phase 2 Clinical Trial in Type 2 Diabetes and Outcome of Annual General Meeting

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/

About VVP808

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.

About Verva
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.

Contact:
Vince Wacher
CEO
Australia:   +61 (448) 871 479
USA:           +1 (760) 271-4783
e-mail:  vwacher@vervapharma.com

VVP808 Preclinical Research Published in Premier International Journal Diabetes

Melbourne, Australia (15 May, 2012).  Verva Pharmaceuticals Ltd. is pleased to report that a manuscript describing research into the anti-diabetic effect of the Company’s clinical product VVP808 has been accepted for publication in the journal Diabetes; a publication of the American Diabetes Association.

The manuscript¹, entitled “Methazolamide is a New Hepatic Insulin Sensitiser that Lowers Blood Glucose In Vivo” reports detailed preclinical studies conducted by the Metabolic Research Unit of the Department of Medicine at Deakin University and collaborators at the Department of Medicine, University of Melbourne, Austin Hospital (Victoria, Australia).  The results demonstrate that VVP808 (methazolamide) acts as an insulin sensitizer that suppresses endogenous glucose production in rodent models of diabetes.  The anti-diabetic effect of methazolamide does not appear to be a function of its known activity as a carbonic anhydrase inhibitor, suggesting a novel mode-of-action in diabetes.  Importantly, the methazolamide-metformin combination has increased glucose-lowering efficacy relative to the individual components alone.

Verva CEO Vince Wacher commented: “The Diabetes publication represents a tremendous body of detailed and thoughtful work by Professor Ken Walder, Dr. Nicky Konstantopoulos and their team and collaborators.  We are very pleased that their work on this exciting discovery has achieved favourable peer review and has been published by a premier international journal such as Diabetes.

The article can be found on-line at http://diabetes.diabetesjournals.org/content/early/2012/05/08/db11-0578.abstract

¹ Konstantopoulos N, Molero JC, McGee SL, Spolding B, Connor T, de Vries M, Wanyonyi S, Fahey R, Morrison S, Swinton C, Jones S, Cooper A, Garcia-Guerra Lucia, Foletta VC, Krippner G, Andrikopoulos S and Walder KR.  (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

About VVP808
Verva’s lead clinical product VVP808 is a non-thiazolidinedione, non-PPAR-modulating insulin sensitizer that has recently completed clinical proof-of-concept testing in type 2 diabetes.  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 combination with metformin.

About Verva
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.

Verva Pharmaceuticals Announces 2012 Annual General Meeting

Melbourne, Australia (30 April 2012). Verva Pharmaceuticals Ltd. (”Verva”; ACN 074 636 847) is pleased to announce that the Annual General Meeting of Verva shareholders will be held on Monday 28 May, 2012 at 9:00 am in the offices of Middletons Lawyers, Level 25, 525 Collins Street, Melbourne, Victoria, Australia.

The Notice of Meeting and Proxy form for the AGM have been mailed to shareholders and are available on-line. Verva’s 2011 Annual Report, including audited financial statements, is also available on the Verva website (Verva 2011 Annual Report). A hard copy is available upon request.

Verva Reports Passing of Verva Director Dr. Andrew Rainsford Baker

Melbourne, Australia (23 March, 2012).  Verva Pharmaceuticals Ltd. regretfully reports the recent passing of Verva Director Dr. Andrew Baker after a battle with cancer.  Andrew was 50 years old.  He is survived by his wife Nancy, son Sam and daughter Clare.

Andrew was a Partner at GBS Venture Partners and one of Verva’s founding Directors.  Andrew drew on his extensive international industry experience (including work with industry leaders Genentech, Bayer and Johnson & Johnson) to provide essential guidance and strategic advice in advancing Verva’s corporate and product development programs.

Verva CEO Vince Wacher stated: “We are very saddened by Andrew’s untimely loss and express our heartfelt condolences to his family.”

A Memorial Service for Andrew will be held at St. Leonards Uniting Church, 2 Wolseley Ave, Brighton, Victoria on Monday 26 March 26, 2012 at 1.30 p.m.  In lieu of flowers, donations to the Australasian Sarcoma Study Group would be greatly appreciated.  http://www.australiansarcomagroup.org/support-sarcoma-research.html.  Please note Andrew Baker as the bequest.

Andrew’s seat on the Verva board will be assumed by Dr. Steve Gourlay, also a Partner at GBS Venture Partners.

Isis Initiates Phase 1 Clinical Trial of ISIS-FGFR4Rx a Peripherally Acting Drug to Treat Obesity

CARLSBAD, Calif., Dec. 20, 2011 /PRNewswire/ — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity.  ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body’s ability to store fat while simultaneously increasing fat burning and energy expenditure.   Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects.  Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects. 

 

“Obesity is an epidemic in the United States and much of the rest of the industrialized world.  Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers.  Severely obese patients make up the most rapidly growing part of the obese population.  In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients,” said Richard Geary, Ph.D., Senior Vice President of Development at Isis.  “Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles.  Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects.”

 

“We are developing ISIS-FGFR4Rx for patients who are severely obese and for the treatment of obesity in patients who are at high risk for cardiovascular and metabolic diseases.   In preclinical studies, inhibition of FGFR4 led to robust and sustained weight reduction in obese animals, accompanied by an improvement in insulin sensitivity,” said Sanjay Bhanot, M.D., Ph.D., Vice President of Clinical Development and Translational Medicine at Isis.  “In obese animals, antisense inhibition of FGFR4 enhanced weight loss when administered as a single agent or in combination with an appetite-suppressing drug, suggesting that peripheral inhibition of FGFR4 in combination with other types of anti-obesity drugs could be a novel therapeutic approach for the treatment of obesity.  Because ISIS-FGFR4Rx selectively alters fat metabolism in metabolically active tissues such as liver and fat without distributing to the brain or heart, we do not expect ISIS-FGFR4Rx to produce cardiac or CNS side effects.” 

 

ISIS-FGFR4Rx is the first drug in Isis’ metabolic franchise to treat obesity and utilizes technology Isis in-licensed from Verva Pharmaceuticals.

 

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis’ broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and cancer.  Isis’ partner, Genzyme, plans to commercialize Isis’ lead product, mipomersen, following regulatory approval, which is expected in 2012.  Isis’ patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

 

ISIS PHARMACEUTICALS’ FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding the discovery, development, activity, therapeutic potential and safety of ISIS-FGFR4Rx.  Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of mipomersen, is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2010 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

 

In this press release, unless the context requires otherwise, “Isis,” “Company,” “we,” “our,” and “us” refers to Isis Pharmaceuticals and its subsidiaries, including Regulus Therapeutics Inc., its jointly owned subsidiary.

 

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. 

 

SOURCE Isis Pharmaceuticals, Inc.

Kristina Lemonidis, Director, Investor Relations, +1-760-603-2490; or Amy Blackley, Ph.D., Assistant Director, Corporate Communications, +1-760-603-2772, both for Isis Pharmaceuticals, Inc.