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RELIEF_DPN_1_supplemental.pdf (614.37 kB)

Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of a Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study

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posted on 2024-06-19, 00:10 authored by Rodica Pop-Busui, Anand Patel, Christine Nai-Mei Sang, Phillip L. Banks, Phillip F. Pierce, Franklin Sun, Craig Granowitz, Suma Gopinathan

Objective: To evaluate the efficacy of LX9211 in reducing pain related to diabetic peripheral neuropathy (DPN).

Research Design and Methods: This double-blind, multicenter, proof-of-concept trial randomized (1:1:1) 319 individuals with diabetic peripheral neuropathic pain (DPNP) to LX9211 10 mg (n=106), LX9211 20 mg (n=106), or matching placebo (n=107), administered once daily for 6 weeks. DPNP was rated daily using an 11-point numerical rating scale. The primary endpoint was change from baseline to week 6 in the average daily pain score. The difference between each LX9211 dose group and placebo was evaluated by mixed model repeated measures analysis.

Results: Low-dose LX9211 achieved the primary efficacy endpoint: -1.39 versus -0.72 points for placebo; LS mean (SE) difference: -0.67 (0.249), 95% CI: -1.16, -0.18, p=0.007; the high-dose LX9211 demonstrated improvement in pain severity versus placebo (-1.27 vs. -0.72 points, respectively), but the between-group difference did not reach the prespecified statistical significance (-0.55 (0.254), 95% CI: -1.06, -0.05, p=0.030). Treatment benefit was observed beginning at week 1 and maintained thereafter. LX9211 also demonstrated improvement in several patient-reported secondary outcomes. Most common adverse events were dizziness, nausea, and headache. More participants treated with LX9211 (20 mg: 28 [26.4%], 10 mg: 17 [16.0%]) than placebo (3 [2.8%]) discontinued study drug prematurely due to adverse events; serious adverse events were uncommon (2 [1.9%], 0, and 1 [0.9%], respectively).

Conclusions: These preliminary findings of improvement in DPNP with LX9211 support further investigation in larger trials.

Funding

This study was funded by Lexicon Pharmaceuticals, Inc., The Woodlands, TX. The study sponsor was involved in the design of the RELIEF-DPN 1 study, collected data from the study investigators, and performed statistical analyses of the data. Authors of this manuscript, including those employed by the Sponsor, interpreted the study data, wrote/revised the manuscript, and made the decision to submit the manuscript for publication.

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