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news.TorreyPines Therapeutics, a biopharmaceutical company, has announced positive results from a 26 patient Phase II trial evaluating three doses of NGX267 as a treatment for xerostomia in patients with Sjogren's syndrome.
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According to the company, NGX267 met the primary endpoint of a statistically significant increase in salivary flow production compared to placebo at all three doses: 10mg, 15mg, and 20mg. These doses were safe and well tolerated with few reports of excessive sweating and gastrointestinal complaints.
The randomized, double-blind, placebo-controlled, in-clinic trial used a cross-over design to evaluate the efficacy, safety and tolerability of three doses of NGX267. A total of 26 patients with xerostomia associated with primary or secondary Sjogren’s syndrome were enrolled at three sites in the US. In four distinct treatment periods, each patient was randomized to receive a single dose of 10mg, 15mg and 20mg of NGX267 and placebo. Patients remained in the clinic and serial efficacy assessments were taken at scheduled time points through 24 hours post dosing.
The 10mg, 15mg and 20mg doses of NGX267 produced statistically significant increases in salivary flow compared to placebo across a number of time points, including the mean salivary flow production over the 24 hour post-dosing period (p=0.025, 0.001, and 0.001, respectively). In addition, the maximum change in salivary flow was statistically significant compared to placebo for each of the three doses of NGX267.
Results of the eight-item patient self-assessment correlated with the quantitative results of salivary production. At the 15mg and 20mg doses, statistically significant differences compared to placebo were demonstrated in a variety of domains including items that rated improvement in speaking and swallowing, dryness of mouth and level of thirst, the company said.
Safety was monitored throughout the evaluation period and NGX267 was shown to be safe and well-tolerated. All patients completed all treatment periods.
Ev Graham, CEO of TorreyPines, said: “The findings from this study are very promising given the demonstrated efficacy and low incidence of adverse events for the three doses of NGX267. Moving forward, we now have data that suggests this well-tolerated product candidate could be effective in treating dry mouth associated with Sjogren’s syndrome, and possibly other conditions in which a reduction in salivary flow has been observed such as the effects of head and neck radiation, diabetes and aging.”