Shares of Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) saw a hand gain early on Friday after the company reported top-line results from its late-stage trial in type-1 diabetes. Specifically, Lexicon announced top-line results from its Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, which ultimately met its primary endpoint.
Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events that were consistent with rates seen in two prior pivotal Phase 3 studies, inTandem1 and inTandem2. This included a similar rate of severe hypoglycemia for the sotagliflozin arm versus the placebo during the treatment period and a slightly higher rate of diabetic ketoacidosis for sotagliflozin than placebo.
Ultimately, these are compelling results for sotagliflozin and could have potential long-term benefits for people with type 1 diabetes. Currently, there are more than 1 million adults with type 1 diabetes in the United States alone.
Satish Garg, M.D., lead investigator of inTandem3 and Professor of Medicine and Pediatrics, and Director Adult Program at the Barbara Davis Center for Diabetes, University of Colorado Denver and Editor-in-Chief, Diabetes Technology and Therapeutics, commented:
The results achieved with sotagliflozin in the inTandem3 study are scientifically and clinically important and significant. If approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type 1 diabetes.
Lonnel Coats, Lexicon’s president and CEO, added:
These positive results represent an important milestone, further supporting sotagliflozin’s differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes. Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase 3 clinical trials in this population.
Shares of Lexicon were closed Thursday at $15.36, with a consensus analyst price target of $26.67 and a 52-week range of $13.01 to $19.62. Following the release, the stock was up about 3% at $15.80 in early indications Friday.