Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain

Summary

Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.

Timeline

Start

2020-09-03

Primary completion

2022-05-23

Completion

2022-06-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs LX9211 100 mg/10 mg; p = 0.007; LS Mean Difference -0.67 (95% CI -1.16 to -0.18); MMRM model NCT04455633 ↗

registry analysis (superiority test); Placebo vs LX9211 200 mg/20 mg; p = 0.030; LS Mean Difference -0.55 (95% CI -1.06 to -0.05); MMRM model NCT04455633 ↗

Publications

• Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PILAVAPADIN	Small molecule	10 mg	Oral
Subject	PILAVAPADIN	Small molecule	20 mg	Oral

Indications