- Lexicon Pharmaceuticals Inc LXRX announced that full results from the RELIEF-DPN-1 trial of its investigational drug LX9211 were presented at the 16th Annual Pain Therapeutics Summit.
- The full data comes from the entire 11-week evaluation period, including a 5-week placebo run-off following the initial 6-week treatment period.
- The data exhibited consistent and statistically significant treatment-period benefits in measures of particular importance in painful diabetic neuropathy (also known as diabetic peripheral neuropathic pain) for both dose arms compared to placebo, such as reductions in burning pain and interference of pain in sleep.
- During the blinded 5-week placebo run-off period, there was a gradual tapering of efficacy in both treatment arms with no evidence of rebound pain or withdrawal symptoms.
- There were no observed differences in treatment-emergent adverse events between the treatment and placebo arms during the run-off period, and no drug-related serious adverse events or deaths were reported in the trial.
- In topline results reported in June, LX9211 achieved the trial's primary endpoint by demonstrating a statistically significant reduction from baseline in average daily pain score at week 6 compared to placebo in the low dose arm (100 mg initial single dose, followed by 10 mg daily doses).
- The study narrowly missed statistical significance in the high-dose arm (200 mg initial single dose, followed by 20 mg daily doses).
- Price Action: LXRX shares are 2.58% higher at $2.39 on the last check Tuesday.
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