Convergence initiates CNV2197944 Phase I study in chronic pain

Convergence Pharmaceuticals Limited ("Convergence"), the company focused on the development of novel and high value analgesic medicines, today announced that the first-time-in-man Phase I study of the novel, first in class calcium channel blocker CNV2197944, for the treatment of chronic pain has been initiated and dosing has begun.

The trial is a randomised, placebo controlled Phase I study to investigate the pharmacokinetics, safety and tolerability of single ascending orally administered doses of CNV2197944. CNV2197944 is proposed for development initially as a treatment for neuropathic pain and pain associated with osteoarthritis. The study is expected to conclude in Q3 2011.

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.

Commenting on the announcement, Dr Simon Tate, Chief Scientific Officer of Convergence Pharmaceuticals, said: "The start of the Phase I trial for CNV2197944 represents an exciting step forward in the extensive research the Convergence team has undertaken in the field of calcium channel blockers. We believe that the unique mode of action of CNV2197944 has the potential to increase the efficacy whilst minimising the unwanted side effects of current pain treatments and will have a significant effect on the quality of life of chronic pain sufferers."

Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, added: "We are delighted to announce the start of this trial and to have begun the first clinical trial in our Company's history ahead of schedule. Sufferers of chronic pain are in desperate need of new innovative treatments and at Convergence we believe we have unparalleled expertise to ensure the success of this exciting molecule. We look forward to reporting the results of this trial in Q3 and look forward with confidence to the next stage of the clinical programme for CNV2197944."

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 develop novel, efficacious analgesics with improved pharmacology and safety profiles.

SOURCE Convergence Pharmaceuticals