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LONDON, UK / ACCESSWIRE / June 12, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for The Woodlands, Texas based Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX). The Company announced on June 09, 2017, that the results from the Phase-3 InTandem3 clinical trials of sotagliflozin tested for the treatment of patients with type-1 diabetes and on any background insulin therapy showed positive top-line results. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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The results of the Phase-3 inTandem3 clinical trials

The study demonstrated that sotagliflozin 400 mg was superior to the placebo in the patients with A1C <7.0% at Week 24. The study also did not record any episode of severe hypoglycemia or diabetic ketoacidosis (DKA) after randomization. Severe hypoglycemia is a diabetic emergency where blood glucose level becomes so low that patients need help from another person for treatment. Diabetic ketoacidosis is a serious diabetes complication where the body produces excess blood acids (ketones).

The Company plans to publish the complete analysis and date of the Phase-3 InTandem3 clinical trails along with the safety data in a peer-reviewed journal.

During the 24-week trials and treatment of patients, Sotagliflozin demonstrated a generally well tolerated safety profile and were similar to those recorded during the earlier conducted InTandem1 and InTandem2 Phase-3 studies. Results showed that the rate of severe hypoglycaemia in the InTandem3 study was 3% compared to 2.4%f or placebo, while the rates of DKA in the two groups were 3% and 0.6%, respectively.

Commenting on the positive top-line results for sotagliflozin, Lonnel Coats, President and CEO of Lexicon said:

"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."

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 said:

"If approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type-1 diabetes."

Jorge Insuasty, Senior Vice President, Head of Global Development, Sanofi added:

"These compelling results speak to the potential long-term benefits that sotagliflozin may bring to people with type-1 diabetes. We look forward to pursuing regulatory submissions for the treatment of type-1 worldwide and to continuing to study the use of sotagliflozin in adults with type-2 diabetes."

About InTandem3 Phase-3 Clinical trails

InTandem3 clinical trial was a global randomized, double-blind, placebo-controlled, parallel-group, multicenter study. The InTandem3 trials was conducted on 1,402 patients with type-1 diabetes on continuous subcutaneous insulin infusion or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. These patients were diagnosed with type-1 diabetes and inadequate glycemic control on insulin therapy alone. These patients were treated with daily dosage of 400 mg of sotagliflozin taken before the first meal of the day, against placebo. The main objective of this trial was to prove the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with glycosylated A1C <7.0% and also that by the end of the 24-week study, there were no episode of severe hypoglycemia or DKA after randomization.

About Sotagliflozin and collaboration with Sanofi

Sotagliflozin is an investigational new first-in-class oral dual inhibitor of sodium-glucose cotransporters-1 and -2 (SGLT-1 and SGLT-2), the two proteins responsible for regulation of glucose absorption in the body. SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose re-absorption by the kidney. Sotagliflozin was developed by Lexicon and is being tested for the treatment of type-1 and type-2 diabetes. The Clinical trials for sotagliflozin, InTandem1 Phase-3 study met its endpoint in September 2016 and InTandem2 Phase-3 study met its endpoint in December 2016.

Lexicon joined hands with Pharma major Sanofi and signed a collaboration and license agreement in November 2015, wherein Sanofi was given the global royalty bearing right and license to develop, manufacture and commercialize sotagliflozin. The agreement does not cover Japan. As per the agreement, Lexicon was to handle all the clinical development activities relating to type-1 diabetes with exclusive option of co-promoting and commercialization of the treatment of type-1 diabetes in the US in collaboration with Sanofi. On the other hand, Sanofi was responsible for the clinical development and commercialization of sotagliflozin for the treatment of type-2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type-1 diabetes outside the US (excluding Japan).

About Lexicon Pharmaceuticals

Lexicon is a fully integrated biopharmaceutical Company that applies a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for people with serious, chronic conditions. The scientists at Lexicon have studied the role and function of nearly 5,000 genes under the Company's Genome5000? program. Under this program, in the last 20 years the scientists have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. The Company had recently launched XERMELO? (telotristat ethyl), a drug for the treatment of carcinoid syndrome diarrhea.

Last Close Stock Review

At the closing bell, on Friday, June 09, 2017, Lexicon Pharma's stock rose 6.77%, ending the trading session at $16.40. A total volume of 4.87 million shares have exchanged hands, which was higher than the 3-month average volume of 779.62 thousand shares. The Company's stock price surged 3.34% in the last three months, 4.13% in the past six months, and 13.49% in the previous twelve months. Moreover, the stock rallied 18.58% since the start of the year. The stock currently has a market cap of $1.71 billion.

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