- Lexicon Pharmaceuticals Inc.'s diabetes drug hit all the secondary endpoints of a pivotal late-stage study, reinforcing the company's belief it has a differentiated product able to compete in the crowded therapeutic area.
- Compared to the type 1 diabetes patients on placebo treatment, those treated with Lexicon's sotagliflozin showed a significantly higher "net benefit" — defined as A1C, which reflects blood glucose levels, below 7% and no instances of severely low blood sugar and diabetic ketoacidosis — in the inTandem2 trial.
- What's more, the trial's experimental arm had significantly more positive changes to body weight, bolus insulin use and fasting plasma glucose, as well as better responses to two questionnaires about patient health as it relates to disease management.
Diabetes is a hard market to break into, largely because there are already so many approved treatments for the disease. The competition is so intense, in fact, that pharmacy benefit managers (PBMs) like CVS Health Corp. and Express Scripts Holding Corp. have been in a stronger position to negotiate more substantial rebates and discounts in recent years, which has crimped diabetes drugmakers' bottom lines.
Looking to clear those hurdles, pharmaceutical companies have tried to demonstrate their products are useful for more than just managing blood sugar.
Johnson & Johnson, AstraZeneca plc and the team of Boehringer Ingelheim and Eli Lilly & Co., for instance, all took on large and highly expensive clinical investigations assessing whether their respective diabetes medicines, Invokana (canagliflozin), Farxiga (dapagliflozin) and Jardiance (empagliflozin), also improved patients' cardiovascular health.
In sotagliflozin's case, meeting secondary endpoints such as weight loss may convince regulators or physicians of its potential in the cardiovascular space.
"The observation that sotagliflozin significantly lowers blood glucose and favorably affects body weight and blood pressure without an increase in hypoglycemia strengthens the potential of the drug to become a first-in-class therapy in the treatment paradigm for type 1 diabetes," Thomas Danne, head of the Diabetes Center at the Children’s Hospital on the Bult in Hannover, Germany, and primary investigator for inTandem2, said in an Aug. 15 statement.
In addition to meeting all secondary outcomes, sotagliflozin previously hit inTandem2's primary outcome of significantly improved A1C from baseline to week 24. Lexicon also disclosed on Aug. 15 that the A1C benefit from its drug was sustained across 52 weeks.
"Today’s results underscore sotagliflozin’s benefit/risk profile and highlight its differentiated profile in the type 1 diabetes landscape,” Lexicon's Chief Medical Officer Pablo Lapuerta said in the statement. His company plans to present more complete data from inTandem2 at a later medical conference.
Lexicon stock was largely unchanged by market's open on Tuesday, down three cents from the prior day's close to $14.86 apiece. Shares closed at $14.61 apiece, down about 1.7%.