SGL1/2 inhibitor Zynquista clinical success compared to Englenet

This is a multicenter, 2:2:1 randomized, double-blind, placebo-controlled and positive drug control, parallel group study, in about 700 patients with type 2 diabetes treated with DPP4 inhibitors (co-or non-conometridonta), but with poor blood sugar level control, compared sotagflozzzin (400 mg), empaglizzin (25 mg), placebo efficacy and safetyThe main endpoint of the study was the superiority of the treatment in the 26th week of sotagliflozin relative to placebo in reducing blood glucose levels (A1C levels from baseline) and the key secondary endpoint was the ineffectocity of solitagflozzin in reducing blood sugar levels (A1C levels from baseline) in week 26Empagliflozzin is a heavy-duty SGLT2 inhibitor class of sugar-lowering drug launched by the Bollinger Ingeheim-Lilly Diabetes Alliance under the brand name Jardiance, with global sales of $2.12 billion in 2018, accounting for more than 50% of the SGLT2 inhibitor marketresults showed that the study reached a major end point: in the 26th week of treatment for patients with type 2 diabetes treated with DPP4 inhibitors, sotagliflozin (400 mg) showed superiority in reducing A1C compared to placeboIn addition, the study reached a key secondary endpoint: in the 26th week of treatment, sotagliflozzin (400mg) showed no poor efficacy in reducing A1C compared to empagliflozin (25mg)In the study, sotagliflozin was well tolerated and the safety results were consistent with previously reported resultsSOTA-EMPA study is the fourth of nine core PHASE III studies in the Sotagliflozin Program for the Treatment of Type 2 Diabetes, and the full results of the study will be presented at an upcoming medical conference"We are pleased that today's results show that sotagliflozin's clinical performance is comparable to that of empagliflozin and is consistent with previous safety," said Pablo Lapuerta, executive vice president and chief medical officer ofLexicon PharmaceuticalsWe look forward to publishing top-line data for the remaining core Phase III studies of the sotagliflozin treatment of type 2 diabetes in early 2020Zquistynquista's active pharmaceutical ingredient is sotagliflozin, a sGLT-1/SGLT-2 dual-acting inhibitor that is being developed for the treatment of type 1 and type 2 diabetesSGLT is called sodium-glucose co-transportprotein, there are 2 types, SGLT-1 is mainly responsible for glucose absorption in the gastrointestinal tract, SGLT-2 is mainly responsible for the reabsorption of glucose in the kidneyssotagliflozin was developed by Lexicon, and Sanofi reached a $1.7 billion licensing agreement with Lexicon in November 2015 to acquire exclusive global rights to the drug outside JapanHowever, in July this year, Sanofi announced that it was ending its partnership with Lexicon on the sotagliflozin projectSanofi's reasoning is that in two Phase III studies (SOTA-CKD3, SOTA-CKD4) conducted in patients with type 2 diabetes with moderate (stage 3) and severe (stage 4) chronic kidney disease (CKD), the data did not meet Sanofi's intended goalsregulatory aspect, Zynquista received EU approval at the end of April this year as an insulin-assisted drug for adult patients with a body mass index of 27kg/m2 and the best insulin therapy that still does not achieve adequate blood sugar control for type 1 diabetes (T1D)Zynquista is administered by oral dose at 200 mg and 400 mg once dailyBut in the U.S., Zynquista was rejected by the FDA in late MarchIn addition to type 1 diabetes, Zynquista is currently in Phase III clinical development for the treatment of type 2 diabetesThe drug's type 2 diabetes development program has 11 clinical studies, including 2 studies in people with type 2 diabetes with kidney damage, and two large cardiovascular outcome studiesSGLT inhibitors are a new class of sugar-lowering drugs that have been a great success in the treatment of type 2 diabetesSeveral pharmaceutical companies are currently developing SGLT inhibitors to treat type 1 diabetes (T1D) and heart failureFor type 1 diabetes, three SGLT drugs have been approved so far, including Astellas Suglat (Iglesias, approved in Japan), AstraZeneca Forxiga (Daglenet, approved by the European Union, Japan), Lexicon's Zynquista (Sogrenet, or EU)Although several SGLT inhibitors have been approved for the treatment of type 1 diabetes (T1D) in the European Union and Japan, no SGLT inhibitors have been approved in the United StatesIn March and July of this year, Zynquista and Farxiga were rejected by the FDA for T1D treatment for the higher proportion of patients in the study group who had ketoacidosis (DKA) than the placebo groupDKA is a common diabetes complication with a higher incidence in Patients with T1D than in Patients with T2Din mid-November, the FDA's Advisory Committee on Endocrinology and Metabolic Drugs (EMDAC) issued a high-vote recommendation against the Bollinger Ingeheim-Lilly Diabetes Alliance's empagliflozin 2.5mg treatment of type 1 diabetes indicationsDuring the drug review process, the Advisory Committee provides the FDA with independent advice and recommendations from outside medical expertsThe FDA is under no obligation to follow the advisory board's recommendations, but often does soThis also means that a new application for a new indication of 2.5mg of empagliflozin to treat type 1 diabetes is likely to eventually be rejected by the FDAAt present, the FDA has not yet made a final decision on whether empagliflozin can defuse the danger, break the spell, achieve zero breakthrough, let us wait and see!original origin: LEXICON PHARMACEUTICALS ANNOUNCES TOPLINE PHASE 3 DATA FOR SOTAGLIFLOZIN IN TYPE 2 DIABETES