Convergence Pharmaceuticals Announces Start of Phase II Study for Cav2.2 Selective Blocker, CNV2197944 in Pain Associated with Diabetic Peripheral Neuropathy (DPN)

CAMBRIDGE, England, July 8, 2013 /PRNewswire/ --

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 has started a Phase II proof of concept study with CNV2197944 in pain associated with diabetic peripheral neuropathy (DPN).  Results from the study are expected in the second half of 2014.

The trial is a randomised double-blind, placebo controlled, Phase II, two period, two treatment crossover study to compare the efficacy and safety of a dose regime of CNV2197944 75mg tid versus placebo in patients with DPN. The primary endpoint of the trial is the effect of repeat oral dosing of CNV2197944 on the pain experienced in DPN, as measured by the Pain Intensity Numeric Rating Scale (PI-NRS), after three weeks, compared to baseline.  

Diabetic peripheral neuropathy (DPN) is defined as peripheral somatic or autonomic nerve damage attributable to diabetes mellitus. DPN is characterised by numbness and paraesthesia, typically of a burning quality with nocturnal worsening, most frequently in the feet and ankles and to a lesser extent in the upper extremities.  Symptoms may also include spontaneous deep aching pain and/or shooting pain, thermal hyperalgesia, and tactile allodynia. It is estimated that up to a quarter of all diabetic patients will suffer from peripheral neuropathic pain and with only a third of diagnosed patients achieving greater than 50% pain relief, DPN presents a huge unmet clinical need.

CNV2197944 is a novel, small molecule, state-dependent calcium channel blocker, designed to selectively inhibit highly active Cav2.2 channels. Based on positive pre-clinical and clinical data already reported, it is believed that CNV2197944 will be an effective treatment for neuropathic pain with 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. CNV2197944 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.

Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, commented: "We have begun running a second proof of concept trial with CNV2197944 in neuropathic pain and are already excited about potential results.  Based on the known pre-clinical and clinical profile of CNV2197944, and the data we have seen so far, we believe it will be a safer, more effective treatment for chronic pain, with a potentially better tolerability profile and wider therapeutic index than currently available treatments."

About the pain therapeutic area

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]

About Calchan

As part of a restructuring of Convergence in 2011, CNV2197944 was subsequently transferred into Calchan Ltd, a sister company of Convergence Pharmaceuticals in which the proprietary rights to CNV2197944 are held. 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-Jane Elliott/ Amber Bielecka/ Matthew Neal
T: +44(0)20-7920-2330
E: convergence@mcomgroup.com