Lexicon Pharma (LXRX) Realigns Business Around Research and Development Assets, with Focus on Phase 2 LX9211 Neuropathic Pain Program
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it is realigning its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development. In that regard:
- Initiation of Phase 2 Clinical Development of LX9211. Lexicon has initiated patient screening in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain that is expected to enroll approximately 300 patients at 30 U.S. sites. Lexicon is preparing for additional Phase 2 studies of LX9211, a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1), in other areas of neuropathic pain based on promising results in multiple preclinical models of neuropathic pain and a favorable Phase 1 clinical safety profile.
- Sale of XERMELO to TerSera. Lexicon entered into an asset purchase and sale agreement with TerSera Therapeutics LLC for the sale of Lexicon’s XERMELO® (telotristat ethyl) product and related assets for up to $224 million in upfront and milestone payments, consisting of approximately $159 million in cash at closing and up to $65 million in development, regulatory and sales milestones relating to biliary tract cancer, plus eligibility for mid-teens royalties on net sales of XERMELO in biliary tract cancer. As part of the transaction, TerSera has agreed to assume the currently ongoing TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to XERMELO. MTS Health Partners, L.P. served as financial advisor and WilmerHale served as legal counsel to Lexicon.
- Debt Reduction. Lexicon will use the upfront proceeds from the XERMELO sale to substantially reduce its debt, including full repayment of its $150 million secured term loan.
“We are implementing a strategic realignment of Lexicon around some truly compelling assets, with a focus on LX9211 for neuropathic pain and other early-stage research and development programs,” said Lonnel Coats, Lexicon’s president and chief executive officer. “The sale of our commercial product, XERMELO, to TerSera provides a home for an important treatment for patients with cancer as well as a number of our employees, allows us to use our resources more efficiently and dedicate appropriate investment to LX9211 development, and enables a substantial reduction of our debt.”
About the RELIEF-DPN-1 Study
RELIEF-DPN-1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of diabetic peripheral neuropathic pain. The study is designed to enroll approximately 300 patients at approximately 30 U.S. clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).