Lexicon’s PROGRESS Data Shows Pilavapadin 10 mg Reduces Pain at Week 8, Supports Phase 3
Lexicon will present PROGRESS Phase 2b data showing pilavapadin 10 mg achieved nominally significant reductions in average diabetic peripheral neuropathic pain at Week 8 versus placebo with tolerability comparable to placebo. Preclinical spasticity data in multiple sclerosis and spinal cord injury models further validate the AAK1 pathway’s therapeutic potential.
1. PROGRESS Phase 2b Study Demonstrates Pilavapadin 10 mg Efficacy
The randomized, placebo-controlled PROGRESS trial enrolled 496 adults with moderate to severe diabetic peripheral neuropathic pain, comparing once-daily pilavapadin doses of 10 mg, 20 mg, and a 20 mg→10 mg transition. At Week 8, the 10 mg cohort achieved nominally significant reductions in average daily pain versus placebo, with consistent improvements in worst and least pain scores and tolerability comparable to placebo, supporting selection of the 10 mg dose for Phase 3 development.
2. AAN Presentation Highlights Preclinical Spasticity Findings
At the American Academy of Neurology annual meeting, Lexicon will present preclinical data showing pilavapadin reduced spasticity endpoints in multiple sclerosis and spinal cord injury models, underscoring the broader therapeutic potential of AAK1 inhibition beyond neuropathic pain and strengthening the case for further clinical exploration.