Convergence Pharmaceuticals Announces Successful Interim Data From Ground-Breaking Phase II Trigeminal Neuralgia Study
Novel sodium channel blocker with excellent pharmacokinetic and safety profile could fill treatment gap for severe pain condition
Convergence Pharmaceuticals Limited (“Convergence”), the company focused on the development of novel analgesic medicines for the treatment of chronic pain, today announces positive interim data from the ongoing Phase II clinical trial of novel sodium channel blocker CNV1014802 in patients with trigeminal neuralgia (TN), a very severe form of facial pain.
CNV1014802 is a novel small molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav 1.7 sodium channel. The Phase II study utilises a novel design, whereby eligible patients are entered into a 3-week open-label treatment period with CNV1014802 at a dose of 150mg three times a day (tid). If a successful response is observed in the final week of this period, patients are then randomised to a 4-week double-blind treatment period with either CNV1014802 150mg tid or placebo.
A planned interim analysis was performed once a pre-defined number of patients had completed the 3-week open-label treatment period. Success criteria for individual patient response was defined as a 30% or more reduction in numbers of paroxysms, or severity of paroxysms, relative to the run-in period. A total of 70% patients showed a successful response and were subsequently randomised into the double-blind treatment period. CNV1014802 was well tolerated in these patients. A Data Monitoring Committee (including medical experts in the treatment of trigeminal neuralgia) reviewed all available efficacy and safety data from the open-label treatment period and agreed that the study should continue to completion as defined in the protocol, using the dose regimen of 150mg tid for CNV1014802.
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.
Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, added: “These interim data are very encouraging. Based on its preclinical and clinical profile, CNV1014802 offers the potential as an effective treatment for neuropathic pain, with a potentially better tolerability profile and wider therapeutic index than currently available treatments. We look forward to reporting full clinical results by the end of 2013.”
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 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.
Source: Convergence Pharmaceuticals