Clinical Trials

* On June 16, 2014, Convergence Pharmaceuticals, a UK company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain via a genetically defined approach, announced positive data from the Phase II clinical trial of novel sodium channel blocker CNV1014802 in patients with trigeminal neuralgia (TGN), a very severe form of facial pain.
Following an initial 21 day open-label treatment period with CNV1014802 at a dose of 150mg three times a day (tid), patients who showed a successful response in the final week of the period, defined as a 30% or more reduction in numbers of paroxysms, or severity of paroxysms, relative to the run-in period, were then randomised to a 28 day double-blind treatment period with either CNV1014802 150mg tid or placebo. All patients entering the study had to have a pre-specified number of paroxysmal attacks of at least moderate severity. A total of 67 patients were recruited into the study and 69% of those patients completing the open label period were randomised as clear responders into the double-blind phase of the study.
CNV1014802 was well tolerated and the study showed a consistent reduction of pain severity and number of paroxysms in all primary and secondary outcomes. In the primary endpoint of the study there was a treatment failure rate of just 33% for CNV1014802 vs 65% for placebo and a favourable separation from placebo on the Kaplan Meier time to relapse. CNV1014802 showed a 2.3 unit decrease in the NRS scale for pain intensity, 60% reduction in paroxysms vs. 12% in placebo and pain severity dropped by 55% vs. 18% placebo, by the end of the study. There were no serious adverse events related to the drug and the adverse event profile of the drug was similar to placebo in the double blind phase of the study.

The full study will be published at the International Association for the Study of Pain (IASP) World Congress of Pain, Buenos Aires in October 2014.CNV1014802 received orphan-drug designation from the US Food and Drug Administration in July 2013 and Convergence will utilise these data to design a pivotal clinical study to start in early 2015 with a view to commercialising an orphan drug as soon as possible.

* On March 28, 2013, Convergence Pharmaceuticals has announced 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. 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. Convergence Pharmaceuticals looks forward to reporting full clinical results by the end of the year.