- Lexicon Pharmaceuticals Inc LXRX announced the topline results of RELIEF-PHN-1 Phase 2 proof-of-concept study of LX9211 in postherpetic neuralgia, a lasting pain in the areas of the skin that had shingles.
- LX9211 achieved a reduction in average daily pain score (ADPS) of 2.42 from baseline at week six compared to a reduction of 1.62 in the placebo arm, with a placebo-adjusted difference of 0.80 (p=0.12).
- Although these results did not reach statistical significance on the study's primary endpoint, overall study results demonstrated clear evidence of an effect.
- Separation of LX9211 from placebo on ADPS was seen at week 1 and maintained consistently after that, with an average placebo-adjusted reduction over the 6 Week dosing period of 0.80 (p=0.03).
- The company says the study included only the higher doses evaluated in RELIEF-DPN-1. The lower dose arm (100 mg on Day 1 and 10 mg after that) in RELIEF-DPN-1 demonstrated statistically significant results on ADPS and meaningfully better tolerability than the higher (200 mg on Day 1 and 20 mg after that) dose.
- Adverse events were consistent with previous studies, with dizziness as the most commonly reported and the most frequently associated with patient dropouts. There were no serious adverse events or deaths reported in the study.
- LX9211 achieved significant and consistent benefits in painful diabetic neuropathy in the RELIEF-DPN-1 study.
- Price Action: LXRX shares are down 8.42 at $1.74 premarket on the last check Thursday.
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