New Drug in Development for Neuropathic Pain

Lexicon Pharmaceuticals and Bristol-Myers Squibb launch drug discovery alliance.

Lexicon Pharmaceuticals recently announced that they have acquired the rights to develop and commercialize a development candidate for a neuropathic pain drug.

Neuropathic pain is a chronic condition that is typically associated with tissue injury, and is characterized by nerve fibers that are damaged, dysfunctional, or injured that then signal pain centers.

The drug, LX9211 (BMS-986176), was developed as a part of the neuroscience drug discovery alliance between Lexicon and Bristol-Myers Squibb Company, according to a press release.

LX9211 is a small molecule compound that is orally administered. The drug has shown efficacy in preclinical studies in models of neuropathic pain, Lexicon reported in the press release. The drug is also well-tolerated in animal models included in these studies.

The drug is currently finishing investigational new drug-enabling studies. Phase 1 clinical trials are expected to start in 2017.

Also included in the agreement are other small molecule compounds that affect the same target as LX9211.

“In our alliance with Bristol-Myers Squibb, we jointly discovered and extensively characterized a promising new target and novel compounds for neuropathic pain, ultimately selecting LX9211 as a development candidate,” said Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer, Lexicon Pharmaceuticals. “This program demonstrates the utility of Lexicon’s science and the value that we have been able to create through our strategic alliance with Bristol-Myers Squibb. Our acquisition of full development and commercialization rights to this program furthers our strategy of developing drug candidates with the potential for changing the standard of care in areas of high unmet medical need.”

The drug discovery alliance was created in 2003 to create small molecule drugs associated with neuroscience. Lexicon started the alliance with numerous drug discovery programs, and utilized its gene knockout techniques to find additional targets within the neuroscience field, according to the press release.

Small molecule compounds that were validated and selected under the alliance, the 2 companies worked together to conduct the nonclinical development of these small molecule drug candidates.

Under the acquisition, Lexicon will pay Bristol-Myers Squibb development and regulatory milestones at the start of phase 2 clinical trials of the drug. Lexicon will pay additional milestones for any other indications that LX9211 receives.

Lexicon will also pay royalties to Bristol-Myers Squibb on the net sales of related small molecules that act through the same target in addition to sales performance milestones, according to the press release.

“Working together with Bristol-Myers Squibb, we have accumulated an extensive amount of data supporting the potential of LX9211 for neuropathic pain and other chronic pain indications,” said Praveen Tyle, PhD, Lexicon’s executive vice president of research and development. “With the nearing completion of IND-enabling studies, we are planning to advance LX9211 into the clinic next year so that patients in an area of high unmet need can benefit from this innovation.”