Start Of Phase II Study For Cav2.2 Selective Blocker, CNV2197944 In Pain Associated With Post-Herpetic Neuralgia Announced
Convergence Pharmaceuticals Limited (“Convergence”), the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain, announced that it has started a Phase II proof of concept study with CNV2197944 in pain associated with post-herpetic neuralgia (PHN). Convergence is conducting the development of CNV2197944 on behalf of Calchan Ltd.
The trial is a randomised double-blind, placebo controlled, phase II study to evaluate the efficacy and safety of orally administered CNV2197944 in patients with PHN. The primary endpoint of the trial is the effect of repeat oral dosing of CNV2197944 on the pain experienced in PHN, as measured by the Pain Intensity Numeric Rating Scale (PI-NRS), after three weeks, compared to baseline. The study is expected to conclude in 1Q2014.
Post-herpetic neuralgia (PHN) is a nerve pain due to damage caused by the varicella zoster virus (Shingles or Chicken Pox). Typically, the neuralgia is confined to a dermatomic area of the skin and follows an outbreak of the virus in the same dermatomic area. Injury to sensory nerves can cause excruciating pain, sometimes persisting for months or years.
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.
Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, added: “We are very excited to be starting the first proof of concept trial with CNV2197944 in neuropathic pain. We strongly believe that CNV2197944 has the optimum profile for success in this neuropathic pain area, which is in real need for efficacious and safe pain treatments. CNV2197944 has the potential to have broad applications across the pain spectrum and we look forward to announcing further proof of concept trials with CNV2197944 beyond PHN.”
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.
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.
1) Global Industry Analysts Inc. 2010, “Pain Management: A Global StrategicBusiness Report”