The Woodlands, TX – December 18, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced positive topline results from its Phase 1a study of LX9211, a potent oral small molecule inhibitor of adaptor associated kinase 1, or AAK1, in development for the treatment of neuropathic pain.
"We are pleased that the initial clinical data for LX9211 confirms the drug candidate’s preclinical profile," said Praveen Tyle, Ph.D., executive vice president of Research and Development at Lexicon. "LX9211 was well tolerated with predictable pharmacokinetics. At doses tested, drug levels of LX9211 were at biologically relevant concentrations and support the therapeutic potential of this highly selective inhibitor of AAK1. We look forward to initiating a multiple ascending dose study for LX9211 in the first quarter of 2019.”
The Phase 1a study met its primary objectives, demonstrating a favorable safety and tolerability profile in healthy human subjects and identifying the maximum tolerated dose.
The randomized, double-blind, placebo-controlled, ascending single dose Phase 1a study was performed to evaluate the safety, tolerability and pharmacokinetics of orally administered LX9211 in healthy volunteers. The study was comprised of 10 cohorts over a wide daily dose range of 5 mg to 200 mg. LX9211 demonstrated a favorable safety and pharmacokinetics profile supportive of once-daily, or less frequent, dosing. Pharmacokinetics were dose proportional over virtually all of the dose range and exhibited a minimal food effect. The most common adverse event was headache, and there were no drug-related serious adverse events.
LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical data demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain. Lexicon has exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of and regulatory filings for LX9211 and the potential therapeutic and commercial potential of LX9211. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of LX9211 may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of LX9211 in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of LX9211. As a result, LX9211 may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX2761 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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