Lexicon Pharmaceuticals, Inc. announced that it has enrolled the first patient in PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) studying LX9211, a potent, orally-delivered, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). PROGRESS will enroll adult patients with a diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with moderate to severe DPNP. The primary endpoint of PROGRESS is a reduction of Average Daily Pain Score (ADPS), consistent with the primary endpoint achieved in the successful RELIEF-DPN-1 Phase 2a proof-of-concept study and, informed by regulatory feedback, the primary endpoint planned for Phase 3 studies of LX9211 in DPNP.

The placebo-controlled treatment period of PROGRESS is intended to identify the optimal dosing for Phase 3 studies. Topline data from PROGRESS is expected to be announced in second quarter 2025. LX9211 has previously received Fast Track designation from the FDA for development in DPNP.