Convergence Pharmaceuticals Announces Successful Completion of Phase I for CNV2197944 and Plans Phase II Studies in Neuropathic Pain

CAMBRIDGE, England, July 18, 2012 /PRNewswire/ --

Phase I study data indicates CNV2197944's optimal profile for a chronic pain medication

Convergence Pharmaceuticals Limited ("Convergence"), the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain, today announces that it is designing Phase II proof of concept studies with CNV2197944 in neuropathic pain, following successful completion of Phase I. This novel, small molecule, state-dependent calcium channel blocker, is designed to selectively inhibit highly active Cav2.2 channels. It is the only truly selective Cav2.2 blocker in clinical development and has the potential to be a first in class treatment for chronic pain. Convergence is conducting the development of CNV2197944 on behalf of Calchan Ltd.

Results of the Phase I, placebo-controlled, multiple ascending dose clinical study with orally administered CNV2197944, demonstrated that the drug was well tolerated in all subjects, with few adverse events reported at doses that are expected to fall within the predicted therapeutic range. The compound was also well absorbed following oral administration, with a pharmacokinetic profile that is predictable and consistent in both young and elderly subjects.  These characteristics indicate CNV2197944's optimal profile for a chronic pain medication.

In view of these favourable data, well powered Phase II proof of concept trials for CNV2197944 in neuropathic pain are now being planned.

CNV2197944 - a first in class molecule with potential to be a first in class treatment

CNV2197944 is a novel, small molecule, state-dependent calcium channel blocker, designed to selectively inhibit highly active Cav2.2 channels. Preclinical studies demonstrated that CNV2197944 could have analgesic potential for a broad range of chronic pain conditions. Extensive safety and toxicology studies to support the clinical development of CNV2197944 have also been completed, which suggest an excellent margin of safety and tolerability.

Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, added: "We are delighted to announce the successful completion of Phase I clinical studies with CNV2197944.  We now plan to shortly initiate Phase II clinical trials with CNV2197944.  This will be the second compound originating from the spin-out from GSK in October 2010 that has successfully progressed to proof of concept in the chronic pain area, which is in real need for efficacious and safe pain treatments."  

The need for new drug treatments for chronic pain

The Pain therapeutic area encompasses any disease where pain is a major symptom. The unmet medical need for patients in pain is enormous, with the greatest need being for a more effective therapy that is well tolerated and safe over a long period of time. Within the pain marketplace, current pain treatments are unsatisfactory; overall efficacy is poor (typically 1-2 point reductions on a 10 point scale) and satisfactory to less than 50% of patients. Whilst treatments, such as opioids and non-steroidal anti-inflammatory drugs, are available on the market, many patients obtain little or no relief from these existing analgesics and often such drugs are associated with adverse events, side effects and addiction concerns. This highlights the importance of Convergence Pharmaceuticals' goals to be a world leader in the development of novel, efficacious analgesics with improved pharmacology and safety profiles.

About chronic pain

Currently, more than 1.5 billion people worldwide suffer from chronic pain of varying degrees. Among all types of chronic pain, neuropathic pain stands out with approximately 3-4.5% of the global population affected, with incidence rate increasing in line with increased age of the population. With the unmet clinical need so high, the demand for better pain management therapies, addressing acute and chronic pain, is on the rise.

According to recent research the global pain management market is to reach US$60 Billion by 2015^[1].

As part of a restructuring of Convergence in 2011, CNV2197944 was subsequently transferred into Calchan Ltd. Calchan Ltd is developing its own portfolio of Calcium ion channel modulators and has contracted Convergence to undertake certain development activities with CNV2197944 on its behalf.

References:

1. Global Industry Analysts Inc. 2010, "Pain Management: A Global Strategic Business Report".

http://www.strategyr.com/Pain_Management_Market_Report.asp

About Convergence Pharmaceuticals

Convergence Pharmaceuticals is an independent biotechnology company focused on the development of novel analgesics with potentially commercially attractive efficacy, responder-rate and side effect profiles. The Company, led by CEO Clive Dix, was formed in October 2010 following the acquisition of certain neuroscience clinical assets from GlaxoSmithKline ("GSK"). The Company  has a pipeline of differentiated clinical-stage compounds targeting the points of convergence in chronic pain signalling through modulation of specific ion-channels.

Convergence Pharmaceuticals is well funded and raised US$35.4 million in Series A financing from a syndicate of leading European and US financial institutions. For more information please go to the Company's website at http://www.convergencepharma.com.

For more information about Convergence Pharmaceuticals, please contact:

Convergence Pharmaceuticals
Dr Clive Dix, Chief Executive Officer
Dr Simon Tate, Chief Scientific Officer
T: +44(0)1223-755-501
E: info@convergencepharma.com

M:Communications
Mary Clark/ Amber Bielecka/ Hollie Vile
T: +44(0)20-7920-2330
E: convergence@mcomgroup.com