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LONDON, UK / ACCESSWIRE / December 22, 2016 / Active Wall St. blog coverage looks at the headline from Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) as the Company announced on December 21, 2016, that its pivotal in Tandem2 Phase 3 clinical trial of sotagliflozin met its primary endpoint of a statistically significant reduction in A1C (A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past 3 months) which is used at 24 weeks in patients with type 1 diabetes on optimized insulin therapy. The results confirmed the outcome in the first Phase 3, Tandem1, reported in September. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of Lexicon Pharma's competitors within the Biotechnology space, Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), reported on December 12, 2016, its financial results for the second quarter of FY17 ended October 31, 2016. AWS will be initiating a research report on Peregrine Pharma in the coming days.

Today, AWS is promoting its blog coverage on LXRX; touching on PPHM. Get all of our free blog coverage and more by clicking on the links below:

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The Results

Lexicon stated that the top-line results from the Phase 3 study demonstrated that patients treated with sotagliflozin had mean A1C reductions from baseline of 0.39% on 200mg once daily sotagliflozin dose (p

"These top-line results confirm the results we announced earlier this year from our first pivotal Phase 3 study of sotagliflozin," said Lexicon President and Chief Executive Officer, Lonnel Coats, "We are extremely pleased with the results in both of these Phase 3 studies and are enthusiastic about the potential benefits that sotagliflozin may bring to people with type 1 diabetes."

The Tandem2 Study

The Tandem2 study randomized 782 adult patients in Europe and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy and who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo.

Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C levels after the six-week optimization period were 7.80%, 7.74%, and 7.71% for patients randomized to the placebo, 200mg and 400mg arms, respectively.

The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with total treatment duration of 52 weeks. There were 257 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p

Lexicon stated that it is conducting a third Phase 3 clinical trial in type 1 diabetes patients, inTandem3, which studies approximately 1,400 patients treated with sotagliflozin 400mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization. The company stated that Sanofi (NYSE:SNY) is responsible for conducting the Phase 3 clinical trials for sotagliflozin in patients with type 2 diabetes.

What is Sotagliflozin?

Lexicon's sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is the primary transporter for absorption of glucose and galactose in the gastrointestinal tract, and SGLT2 is primarily responsible for glucose reabsorption by the kidney. Sotagliflozin has been shown in a Phase 2 study to improve glycemic control in people with type 1 diabetes while reducing their need for mealtime insulin.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, royalty-bearing right and license to develop, manufacture, and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes in the licensed territory and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the US.

Stock Performance

Lexicon Pharma's share price finished yesterday's trading session at $15.23, declining 6.74%. A total volume of 1.69 million shares exchanged hands, which was higher than the 3 months average volume of 595.59 thousand shares. The stock has rallied 9.33% and 12.90% in the last six months and past twelve months, respectively. Furthermore, since the start of the year, shares of the company have surged 14.43%. The stock currently has a market cap of $1.58 billion.

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SOURCE: Active Wall Street