Lexicon Pharmaceuticals’ non-opioid-based therapy has outperformed placebo in 10mg doses in patients with severe diabetic peripheral neuropathic pain (DPNP).
The Phase II dose-finding, placebo-controlled Progress study (NCT06203002) enrolled 600 patients living with DPNP, demonstrating reductions in the mean average daily pain score (ADPS) from baseline through to week eight.
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Patients were split into separate arms to receive LX-9211 10mg, 20mg or an additional arm receiving both high and low doses sequentially. Results from the trial saw a mean reduction in pain score of 1.74, 1.38 and 1.70 respectively using the ADPS system. The trial also included a placebo arm which saw a reduction of 1.31. Now the company plans to move ahead to Phase III trials with the 10mg dose.
Jordan Schnitzer, lead investigator for the Progress trial, said: “DPNP is a complex and highly prevalent complication of diabetes which severely impacts quality of life. People with DPNP often cycle through multiple treatments without adequate relief, and they and their healthcare providers are in dire need of new, non-opioid treatment options.
“The results of the Progress IIb study provide further evidence that AAK1 inhibition may provide an alternative treatment option to opioid use, offering clinically meaningful reductions in pain and the potential for LX-9211 to fill a critical gap in DPNP care.”
LX-9211 is described by Lexicon as an investigational adaptor-associated kinase 1 (AAK1) inhibitor intended as a once-daily, orally delivered, selective alternative to opioid-based pain relief.
The results follow on from the company’s previous Phase II RELIEF-DPN-1 study (NCT04455633) that saw LX9211 achieving a reduction from baseline in ADPS of 1.39 in the low dose arm and 1.27 in the high dose arm against the placebo arm’s 0.72 points. In both trials, there were some mild or moderate adverse events (AEs), more frequently in the 20mg arms, with dizziness and nausea being the most frequently reported events.
Research published in the journal Springer Nature Link in 2019 found that diabetic peripheral neuropathy eventually affects nearly 50% of adults with diabetes during their lifetime. Of those, more than 40% will experience some form of neuropathic pain.
In the event LX-9211 makes it to market, GlobalData’s Pharmaceutical Intelligence Centre estimates that by the end of 2028, the non-opioid therapy could bring in as much as $23m for Lexicon, with that figure estimated to grow to $56m by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Mike Exton, director of Lexicon, said: “We are very encouraged by the topline results from the Progress Phase IIb study, which gives us great confidence in Phase III development of the 10mg dose for DPNP.”
“The neuropathic pain market represents a multibillion-dollar opportunity that is primed for innovative treatments. With these results, we firmly believe that LX-9211 has the opportunity to become the first oral non-opioid treatment approved in neuropathic pain in 20 years. The enormous potential of this investigational medicine has generated significant interest from potential partners, and we intend to accelerate these discussions while we plan for Phase III development,” Exton added.
Elsewhere in the field of non-opioid alternatives, Taiwanese pharmaceutical company Xgene Pharmaceutical has announced that its analgesic drug, XG005, has reduced acute pain in patients after surgery in a Phase IIb study. Meanwhile, Vertex Pharmaceuticals stock has taken a hit after its non-opioid pain therapy wasn’t able to outperform placebo enough.
