484-P: Patient-Reported Burden of Disease in Diabetic Peripheral Neuropathic Pain-Learnings from In-depth Patient Interviews-Substudy of RELIEF-DPN 1

Background and Aims: Diabetic peripheral neuropathy often results in diabetic peripheral neuropathic pain (DPNP) which is difficult to manage effectively with the current standards of care. RELIEF-DPN 1, a Phase 2 study in adult patients with Type 1 or 2 diabetes and moderate to severe established DPNP, evaluated the safety and efficacy of LX9211, a potent non-opioid inhibitor of AP2-associated protein kinase 1 (AAK1). A sub-study of RELIEF-DPN 1, employed patient interviews with the objectives of characterizing pre-trial patient-reported disease burden and assessing unmet need in DPNP management. Methods: Sixty-two telephone interviews were conducted across 31 US clinical sites following a semi-structured interview guide to ensure consistent data capture. Data were analyzed using thematic qualitative data analysis. Dominant trends were compared across interviews to describe themes and relative importance of symptoms observed. Demographic and clinical information were summarized with descriptive statistics. Results: Of 62 patients interviewed, 39 (63%) were male. The average age was 59.7 years. Analyses revealed the most commonly reported symptoms were numbness (89%), tingling (84%), and burning (71%). The symptoms reported as "most bothersome" were burning (30%), numbness (26%), and tingling (26%). The aspects of daily living most impacted by patient's DPNP were sleep (81%), mood (66%), and mobility (66%). Over 40% of patients were "not at all satisfied" with prior treatments for DPNP, while 18% reported being "very satisfied." DPNP was at least "moderately difficult" to manage for 82% of patients; 37% reported it "very difficult." Conclusion: This sub-study demonstrates that, from patients' perspectives, symptoms and aspects of daily living impacted by DPNP are considerably burdensome to patients. This study highlights a pressing need for improved therapy and innovation in DPNP management.