Lexicon pharmaceutical company recently announced that has received the us food and drug administration (FDA) regulatory feedback, its phase 3 trials SOLOIST and SCORED results can support SGLT 1/2 inhibitor class sotagliflozin (Ontario column net) submit new drug applications (NDA) : used for associated with worsening heart failure or there are additional risk factors for heart failure of adults with type 2 diabetes, reduce the risk of cardiovascular death, heart failure, emergency hospital visits.
This regulatory feedback clears a key hurdle for partnership discussions surrounding sotagliflozin for heart failure and makes a potential 2021 NDA filing possible.
Sotagliflozin, an oral SGLT-1/SGLT-2 dual-effect inhibitor, was discovered through Lexicon's unique genetic science approach. SGLT is called sodium-glucose cotransporter, which is responsible for glucose regulation. There are two types of SGLT-1, which is mainly responsible for glucose absorption in the gastrointestinal tract, and SGLT-2, which is mainly responsible for glucose reabsorption in the kidney.
It is worth noting that Sanofi reached a $1.7 billion licensing agreement with Lexicon in November 2015, giving it exclusive rights to Sotagliflozin worldwide, except in Japan. However, in July 2019, Sanofi announced that it was terminating its collaboration with Lexicon on the sotagliflozin project. Sanofi cited two phase III studies (SOTA-CKD3 and SOTA-CKD4) in patients with type 2 diabetes with moderate (stage 3) and severe (stage 4) chronic kidney disease (CKD) as failing to meet Sanofi's expectations.
Sotagliflozin (Zynquista) is an adjutant to insulin for adults with type 1 diabetes (T1D) whose body mass index (BMI) ≥27kg/m2 is unable to achieve adequate glycemic control despite optimal insulin therapy. Zynquista is not currently available for sale. In the United States, approval for sotagliflozin for type 1 diabetes was denied in March 2019.
Clinical study of sotagliflozin in the treatment of heart failure:
SOLOIST is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study evaluating the cardiovascular efficacy of adding sotagliflozin or placebo to standard care in 1222 patients with type 2 diabetes who were recently hospitalized for worsening heart failure. The primary endpoint was the total number of cardiovascular deaths, hospitalizations for heart failure, and emergency visits for heart failure in patients treated with sotagliflozin compared to those treated with placebo.
MALICE is a multicenter, randomized, double-blind, placebo-controlled phase 3 study evaluating the cardiovascular efficacy of adding sotagliflozin or placebo to standard care in 10,584 patients with type 2 diabetes, chronic kidney disease (EGFR: 25-60 ml/min 1.73 m2) and cardiovascular risk. The primary endpoint was the total number of cardiovascular deaths, hospitalizations for heart failure, and emergency visits for heart failure in patients treated with sotagliflozin compared to those treated with placebo.
Both the Soloist study and the magician study reached their main end points. The results of these two studies were presented at the American Heart Association (AHA) Scientific Latest Sessions 2020 Scientific Sessions, and in two articles in the New England Journal of Medicine (NEJM) titled: Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure and Sotagliflozin in Patients with Diabetes and Chronic Kidney diseases.