Positive Results for V158866 in Phase I Study

Vernalis plc today announces positive results from its Phase I trial of V158866, its fatty acid amide hydrolase (FAAH) inhibitor, a novel target with potential application in a wide range of pain and other indications.

 

The double-blind, placebo controlled study investigated single and multiple ascending doses and was conducted in healthy male volunteers. Both single dose and repeated administration for 7 days across a wide range of doses were found to be well tolerated with no safety concerns identified. There were few adverse events at any dose, including the highest dose studied, 500 mg once daily for 7 days. The pharmacokinetics of the compound were found to be straightforward, with good exposures that increased in an approximately linear fashion with oral dosing. There were clear changes in the pharmacodynamic markers (plasma FAAH activity and endocannabinoid concentrations) at all doses studied, including even the lowest single dose (5 mg).

 

The study has confirmed that V158866 is a potent inhibitor of human FAAH and has identified once daily doses to be tested in future studies in pain and/or other indications.

 

Ian Garland, CEO of Vernalis commented "We are delighted with the excellent results of this Phase I study and will continue to progress V158866 through the clinic, moving into a Phase II proof-of-concept study over the next 12 months."

 

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Enquiries:

 

Vernalis Contacts

 

 

Ian Garland, Chief Executive Officer

+44 (0) 118 989 9360

David Mackney, Chief Financial Officer

 

 

Brunswick Group

 

 

Jon Coles

+44 (0) 20 7404 5959

Kristin Shine

 

 

Taylor Rafferty

 

 

Rob Newman

+44 (0) 20 7614 2900

Faisal Kanth

 

 

Notes to Editors

 

About Vernalis

Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in taking promising product candidates along a commercially-focused path to market.  The Group has one marketed product, frovatriptan for the acute treatment of migraine, and eight candidates in development, seven of which are designated priority programmes.  Four of these priority development programmes are currently unpartnered and three are partnered. Pipeline programmes are derived from both our own research activities where we have significant expertise in fragment and structure based drug discovery, as well as from collaborations.  Our technologies, capabilities and products are endorsed by collaborations with Endo, GSK, Lundbeck, Menarini, Novartis and Servier.

 

 

Product

Indication

Pre-Clinical

Phase I

Phase II

Phase III

Marketed

Marketing Rights

PRIORITY PROGRAMMES

CNS Programmes

Frovatriptan

Acute Migraine

 

 

 

 

X

Menarini & Endo Pharma

V158866

Pain

 

X

 

 

 

Worldwide

V81444

Parkinson's Disease

 

X

 

 

 

Worldwide

 

Oncology Programmes

AUY922

Cancer

 

 

X

 

 

Novartis

CHR2797

Cancer

 

 

X

 

 

Chroma Therapeutics

HSP990

Cancer

 

X

 

 

 

Novartis

V158411

Cancer

X

 

 

 

 

Worldwide

 

Other Therapeutic Areas

V85546

Inflammatory Disease

 

X

 

 

 

Worldwide

 

LEGACY PROGRAMMES

RPL554

Asthma/ Allergic Rhinitis

 

 

X

 

 

Verona Pharma

 

 

For further information about Vernalis, please visit www.vernalis.com

 

Vernalis Forward-Looking Statement

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.

 

Posted: September 2011

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