Shares in Vernalis closed up more than 2.5% yesterday as investors welcomed news that the group’s V3381 performed well in a mid-stage trial assessing its potential in neuropathic pain resulting from long-standing diabetes.
Results from the randomised, double-blind, placebo-controlled, Phase IIa study – conducted in five specialist centres in the USA and Canada – showed that the agent was generally well-tolerated and met its efficacy endpoints, thereby warranting its progression into the next stage of clinical development, the group said.
In terms of tolerability, out of the 46 patients starting the trial, 10 withdrew because of side effects, of which three were on placebo and seven were taking V3381 (four in the higher dose arm and three in the lower). But, as Tony Weir, Chief Financial Officer of Vernalis, told PharmaTimes UK News, withdrawal from the study may not be related to the treatment itself. As he explained, the patients taking part in the study are suffering from intense pain, which may cause them to drop out of the trial. In any case, the group had hoped that 30 patients would complete the trials, so were pleased that 35 made it through to the end, he said.
Good safety profile
Neuropathic pain is a chronic form of pain related to damage to nerves and their signalling processes and, unlike other forms of pain, is generally non-responsive to current analgesics, does not diminish over time and can increase in both intensity and area.
The problem with existing therapies to treat the condition, such as Pfizer’s Lyrica (pregabalin), is that they come with very serious side effects, Weir explained, and this significantly affects patients’ ability to take them long-term. Pharmaceutical companies are working very hard to develop a treatment for the condition that can meet this urgent unmet medical need, he said.
Although similar side effects have been recorded with V3381, they are not as significant as those associated with rival drugs on the market, according to Weir. The most common adverse events reported by patients were consistent with previous experience with the drug in Phase I studies, with dizziness and nausea being the most frequent.
After a full analysis of the results have been carried out, Vernalis will be talking to regulators about its plans for a Phase IIb dose-ranging study, which could involve 150-200 patients and start early next year, Weir told PharmaTimes UK News.