Convergence initiates CNV1014802 Phase II study in trigeminal neuralgia

Convergence Pharmaceuticals Limited ("Convergence"), the company focused on the development of novel and high value analgesic medicines, today announced that the Phase II proof of concept study for CNV1014802 for the treatment of pain associated with trigeminal neuralgia (TN) has started. CNV1014802 is novel small molecule, state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav1.7 sodium channel.

TN is a very severe form of facial pain that is experienced in short bursts or attacks. The International Association for the Study of Pain (IASP) defines TN as sudden, severe, brief, stabbing, recurrent episodes of pain usually on one side of the face and can be provoked by light touch. The pain follows one or more branches of the trigeminal nerve which provides nerve sensation from the mouth, face and the front of the scalp.

TN currently affects approximately 50,000 people in the USA alone.  The majority of people affected are over 50 years of age, however many cases have been reported in young adults. TN is more prevalent in women than men, and for most sufferers, the condition is progressive and worsens over time. TN is commonly misdiagnosed and to date there is no guaranteed cure for the condition. Current therapies are centred on sodium channel blockers such as carbamazepine or oxcarbazepine as first-line treatments. However, these agents although providing relief, are often poorly tolerated, and require lengthy dose escalation, resulting in sub-optimal efficacy.

The Phase II trial is a randomised, double-blind, placebo-controlled withdrawal study designed to evaluate the efficacy and safety of orally administered CNV1014802 in patients with TN. The trial will run in six countries and the first results are expected in mid 2013.

Commenting on the announcement Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, said: "We are delighted to announce the start of this Phase II trial in trigeminal neuralgia, our second clinical trial of CNV1014802, following a Phase II proof of concept study initiated in July 2011 for treating pain associated with lumbosacral radiculopathy (LSR). CNV1014802 has already demonstrated an excellent pharmacokinetic and safety profile in over 160 healthy volunteers in Phase I trials. TN is a very debilitating disorder and we are confident that CNV1014802 will help fill the desperate need for innovative new treatments. We look forward to reporting results in 2013."

Prof Joanna Zakrzewska, Consultant and Facial Pain Unit Lead, Eastman Dental Hospital, UCLH NHS Foundation Trust, said: "It is very exciting to have a potential new drug to use in TN as this rare condition has to date had to rely on use of drugs previously developed for other purposes. Convergence has taken the bold step of testing it in a randomised control trial so that high quality evidence will be forthcoming very quickly. Designing studies for pain conditions where it would be unethical to use a placebo has been a challenge and we hope that this design will enable us to recruit the patients so that we can extend our drug therapies, so desperately needed."