Lexicon Completes SONATA-HCM Enrollment, Eyes 2027 Sotagliflozin Data

Lexicon completed enrollment in its Phase III SONATA-HCM trial of sotagliflozin, enrolling more than the planned 500 patients across obstructive and non-obstructive hypertrophic cardiomyopathy. Topline results are expected in the first quarter of 2027. The company has begun pre-launch planning for HCM, including adding commercial and medical-affairs staff, and sees potential for an oral, once-daily treatment—particularly for non-obstructive HCM, where Lexicon says approved options are limited. Lexicon plans to resubmit sotagliflozin for type 1 diabetes in the fourth quarter after supportive STENO1 data, with a possible FDA decision in 2027. It also reported milestone payments from Novo Nordisk and is preparing a potential Phase III program for pilavapadin in diabetic neuropathic pain.

Lexicon Pharmaceuticals NASDAQ: LXRX said it has completed enrollment in its Phase III SONATA-HCM study of sotagliflozin in hypertrophic cardiomyopathy, with topline data expected in the first quarter of 2027. Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Chief Executive Officer Dr. Mike Exton said the company is continuing its transition toward a cardiometabolic focus, with sotagliflozin programs in hypertrophic cardiomyopathy, or HCM, and type 1 diabetes among its principal near-term priorities.

Exton said SONATA-HCM was designed to enroll 500 patients across obstructive and non-obstructive forms of HCM, but the trial ultimately “substantially over-enrolled” that target. Enrollment was completed at the end of July, and the 26-week study uses the Kansas City Cardiomyopathy Questionnaire, or KCCQ, as an endpoint. The company expects to present baseline demographic information from the trial at an HCM-focused medical meeting after the data are cleaned, Exton said.

Lexicon executives emphasized their view that obstructive and non-obstructive HCM represent a continuum rather than wholly separate diseases. Exton said diastolic dysfunction and left ventricular hypertrophy are central features across the condition, while the distinction between obstructive and non-obstructive disease primarily reflects the location of heart-muscle thickening. Chief Medical Officer Dr. Craig Granowitz said HCM has historically been defined in part by available treatments, including surgery and therapies that reduce cardiac contractility. He said sotagliflozin is intended to act through multiple mechanisms, including SGLT2-related cardiorenal and decongestion effects as well as potential direct effects on myocardial energetics through SGLT1. According to Granowitz, SONATA-HCM has broad inclusion criteria, including patients with ejection fractions as low as 50%. The study also permits certain patients using cardiac myosin inhibitors, or CMIs, subject to entry criteria. He contrasted that approach with CMI use in patients with more hyperdynamic heart function.

Exton said Lexicon has begun pre-launch planning for a potential HCM commercialization effort. The company promoted Rachel Martens, previously responsible for partnership and strategy activities, to chief commercial officer. Lexicon also hired a head of marketing, a head of access and five medical science liaisons, he said. The company is conducting market research on the potential positioning of sotagliflozin. Exton said physicians have identified an unmet need in non-obstructive HCM, where he said there are currently no approved treatment options. He said the company believes sotagliflozin could provide an oral, once-daily treatment option with potential use across both obstructive an...