THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ:LXRX) shared new findings from its Phase 3 SCORED clinical trial, indicating that its drug sotagliflozin may offer renal protection for patients with diabetic kidney disease (DKD). The results are scheduled for presentation at the upcoming Kidney Week 2024, hosted by the American Society of Nephrology in San Diego, California.
The recent post hoc analysis of the SCORED trial focused on the effect of sotagliflozin versus placebo on the estimated glomerular filtration rate (eGFR) slope, a measure of kidney function over time, and its impact based on baseline kidney function and glycemic control. The study found a significant placebo-adjusted acute decline in eGFR among participants, with sotagliflozin showing a greater benefit on the chronic slope with increasing baseline albuminuria.
Sotagliflozin, a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2), has been previously recognized for reducing the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes and DKD. The drug works by targeting glucose regulation through the inhibition of SGLT2, which is responsible for glucose and sodium reabsorption in the kidneys, and SGLT1, which controls absorption in the gastrointestinal tract.
Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer, stated that the study contributes significantly to understanding the clinical benefits of sotagliflozin for individuals with DKD. Lexicon has launched INPEFA® (sotagliflozin) in the United States and continues to explore its potential in various patient populations across heart failure, diabetes, and chronic kidney disease.
Lexicon's commitment to pioneering medicines through its Genome5000™ program is evident in its pipeline of drug candidates in various stages of development, targeting diseases such as neuropathic pain, diabetes, metabolism, and others.
The company's press release also includes forward-looking statements regarding its financial position, product commercialization, and the therapeutic potential of its drug candidates. However, these statements are subject to risks and uncertainties, including the company's ability to secure necessary capital, regulatory approvals, and achieve its operational objectives.
The information presented is based on a press release statement from Lexicon Pharmaceuticals, Inc.
In other recent news, Lexicon Pharmaceuticals has witnessed several significant developments. The firm has entered into an exclusive licensing agreement with Viatris for the commercialization of the diabetes drug sotagliflozin outside of the United States and Europe. This strategic partnership is expected to enhance the global reach of the drug, with Lexicon receiving a $25 million upfront payment from Viatris, along with potential for additional milestone payments.
Financially, Lexicon reported a net loss of $53.4 million in Q2 2024, with revenues of $1.6 million, primarily from sales of INPEFA, the marketed form of sotagliflozin. Analyst firms Piper Sandler and H.C. Wainwright have maintained positive ratings for Lexicon, underscoring the potential of the company's drugs.
Changes in the executive team have also been noted, with Jeffrey L. Wade ending his tenure as president and COO, and Kristen L. Alexander stepping into the role of principal financial officer. Lexicon is also preparing for an FDA review of Zynquista and has initiated patient enrollment for the Phase 3 SONATA trial of sotagliflozin in hypertrophic cardiomyopathy. The company anticipates top-line data for the LX9211 study in diabetic peripheral neuropathic pain by Q2 2025.
InvestingPro Insights
Lexicon Pharmaceuticals' recent announcement about the potential renal protection benefits of sotagliflozin aligns with the company's strong revenue growth trajectory. According to InvestingPro data, Lexicon has experienced an impressive revenue growth of 794.59% over the last twelve months as of Q2 2024, with quarterly revenue growth of 419.56% in Q2 2024. This substantial increase in revenue could be indicative of growing market acceptance for Lexicon's innovative treatments, including INPEFA® (sotagliflozin).
Despite the promising clinical results and revenue growth, InvestingPro Tips highlight that Lexicon is "quickly burning through cash" and "not profitable over the last twelve months." This is reflected in the company's operating income margin of -5412.11% for the last twelve months as of Q2 2024. These financial metrics underscore the challenges faced by pharmaceutical companies during the drug development and commercialization phases.
On a positive note, an InvestingPro Tip indicates that Lexicon "holds more cash than debt on its balance sheet," which could provide some financial flexibility as the company continues to invest in its pipeline and the commercialization of INPEFA®. Additionally, the company has seen a "strong return over the last month," with a 22.78% price total return in the past month, suggesting investor optimism about Lexicon's recent developments.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Lexicon Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
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