Convergence Pharmaceuticals Limited (Convergence), an independent biotechnology company focused on the development of novel and high value analgesic medicines, has initiated the multiple ascending dose phase I study of the novel, first in class calcium channel blocker CNV2197944, for the treatment of chronic pain.

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.

The trial is a randomised, placebo controlled phase I study to investigate the pharmacokinetics, safety and tolerability of orally administered multiple dose regimens of CNV2197944 in both young and elderly volunteers. CNV2197944 is proposed for development initially as a treatment for neuropathic pain and pain associated with osteoarthritis. The study is expected to conclude in 2Q 2012.
 
The first human single ascending dose phase I study with orally administered CNV2197944 was recently completed. CNV2197944 was shown to be well absorbed, with an ideal pharmacokinetic profile for the target indication of chronic pain. The compound was well tolerated, with an excellent safety profile.
 
Clive Dix, chief executive officer of Convergence Pharmaceuticals, commented: “We are really excited to be advancing on schedule to a multiple ascending dose study with this novel, first-in-class treatment for chronic pain. The data we have seen so far gives us great confidence that CNV2197944 will be a safe and effective long term treatment for chronic pain.”
 
Currently, more than 1.5 billion people worldwide suffer from chronic pain of varying degrees, with an estimated 116 million American adults affected by chronic pain – more than heart disease, cancer and diabetes combined.  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.