Lexicon stumbles on second batch of mixed results for pain drug
Lexicon Pharmaceuticals has announced topline results from its Phase 2b PROGRESS study evaluating pilavapadin (LX9211) for diabetic peripheral neuropathic pain (DPNP)15. Here are the key details:
Study Results
- The 10 mg dose of pilavapadin achieved meaningful pain reduction compared to placebo, meeting the company's objectives15.
- The 10 mg dose demonstrated a reduction of 1.74 in mean average daily pain score (ADPS) compared to 1.31 for placebo6.
- However, the primary endpoint did not reach statistical significance (p=0.11) for the 10 mg dose6.
- The 20 mg dose and the arm receiving both high and low doses sequentially showed reductions of 1.38 and 1.70 in ADPS, respectively7.
Tolerability and Safety
- Adverse events, primarily dizziness and nausea, were mild to moderate6.
- The 10 mg dose showed improved tolerability compared to higher doses and previous studies15.
Next Steps
- Lexicon plans to advance the 10 mg dose into Phase 3 development for DPNP15.
- This decision is supported by results from both the PROGRESS study and the previous RELIEF DPN-1 study, which collectively enrolled approximately 600 pilavapadin-treated patients15.
Significance
- Pilavapadin is an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor15.
- If successful, it could potentially become the first oral non-opioid treatment approved for neuropathic pain in 20 years6.
While the results are mixed, with the primary endpoint not reaching statistical significance, Lexicon sees the meaningful pain reduction and improved tolerability of the 10 mg dose as encouraging for further development in DPNP6.
Sources:
1. https://www.biospace.com/press-releases/lexicon-pharmaceuticals-announces-topline-results-from-phase-2b-progress-study-evaluating-pilavapadin-lx9211-in-adults-with-diabetic-peripheral-neuropathic-pain
5. https://investors.lexpharma.com/news-releases/news-release-details/lexicon-pharmaceuticals-announces-topline-results-phase-2b
6. https://www.stocktitan.net/news/LXRX/lexicon-pharmaceuticals-announces-topline-results-from-phase-2b-ixvuia6iekqk.html
7. https://www.clinicaltrialsarena.com/news/lexicons-non-opioid-therapy-for-dpnp-beats-placebo-in-pain-reduction/