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Lexicon’s Sunny Take Does Not Sway Investors About Phase IIb DPNP Miss

 
• By Joseph Haas

While Lexicon’s non-opioid pain candidate missed the primary endpoint in a diabetic peripheral neuropathic pain study, the company insisted the data revealed a path forward with a 10mg daily dose.

Lexicon hopes to move into Phase III in diabetic peripheral neuropathic pain despite mixed Phase IIb data

Lexicon Pharmaceuticals presented its Phase IIb data for pilavapadin (LX9211) on 3 March as a win that clarified the dosing regimen to take into Phase III in diabetic peripheral neuropathic pain (DPNP), but shareholders apparently had a different takeaway from the 496-patient PROGESS study, which Lexicon admitted had missed its primary endpoint.

Key Takeaways
  • Tough times continued for Lexicon, which slashed commercial operations last fall, as a Phase IIb study in diabetic peripheral neuropathic pain missed its primary endpoint.
  • The company, however, asserted that the study did show efficacy for a 10mg daily dose of pilavapadin, which it intends to take forward into Phase III

Lexicon previously reported data from the Phase IIa RELIEF-DPN-1 trial in November 2022 that showed the oral adaptor-associated kinase 1 (AAK1) inhibitor met the primary endpoint of improvement from baseline in average daily pain score (ADPS) at six weeks, but with significant safety and tolerability issues

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