Date: 2014-09-23
Type of information: Results
phase: 2
Announcement: results
Company: Convergence Pharmaceuticals
Product: CNV1014802
Action
mechanism: CNV1014802 is a novel small molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav 1.7 sodium channel.
Disease: pain associated with lumbosacral radiculopathy (sciatica)
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On September 23, 2014, Convergence Pharmaceuticals, a UK company focused on the development of analgesic medicines for the treatment of chronic pain, announced positive data from the Phase II proof of concept study with CNV1014802 for treating pain associated with lumbosacral radiculopathy (LSR), more commonly known as sciatica. The Phase II trial was a randomised, double-blind, placebo-controlled cross-over study designed to evaluate the efficacy and safety of orally administered CNV1014802 at a dose of 350mg twice per day, in 81 patients with pain associated with LSR. There was a statistically significant difference in the primary endpoint between CNV101802 and placebo (Pain Intensity-Numerical Rating Scale (PI-NRS) mean change at week 3, -0.43; p=0.0265). Additional exploratory analyses showed that for the subset treated by \'802 alone, comprising 60% of patients randomised, there was an enhanced statistically significant reduction in pain (PI-NRS mean change at week 3, -0.72; p=0.0039). Convergence Pharmaceuticalsrecently reported excellent efficacy and safety in a ground-breaking Phase II trigeminal neuralgia study, a severe form of facial pain. This is the second well powered, randomized and placebo controlled clinical trial to demonstrate clinical proof of concept of the selective state dependent Nav1.7 inhibitor, CNV1014802 in a chronic pain indication. The company will initially target the commercialisation of CNV1014802 in trigeminal neuralgia and other orphan drug conditions.
There were no serious adverse events related to the drug in this trial and as seen in all previous clinical studies, CNV1014802 was very well tolerated. Key to further clinical development and differentiation, CNV1014802 was delivered at an effective therapeutic dose without any requirement for dose titration.
