Lexicon enrolls first patient in Phase 2b Progress study of LX9211

Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS studying LX9211, a potent, orally-delivered, selective, investigational small molecule inhibitor of adaptor-associated kinase 1. PROGRESS will enroll adult patients with a diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus with moderate to severe DPNP. The primary endpoint of PROGRESS is a reduction of Average Daily Pain Score, 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. The open-label extension is expected to run in parallel with planned next-stage Phase 3 studies, supporting long-term safety requirements for regulatory approval. Topline data from PROGRESS is expected to be announced in Q2 2025.