|By PR Newswire||
|April 14, 2014 06:00 AM EDT||
THE WOODLANDS, Texas, April 14, 2014 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose levels through two insulin-independent mechanisms of action.
In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo (p=0.007), while significantly improving glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo (p=0.002). This improvement was accompanied by significant improvement in the time spent in a glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events.
"The results from this study provide a clear demonstration of proof-of-concept of LX4211 as an oral, investigational new drug for type 1 diabetes complementing insulin therapy," said Arthur Sands, M.D., Ph.D., Lexicon's president and chief executive officer. "The magnitude of improved glycemic control by several measures, including HbA1c in only four weeks, and lower insulin requirements are highly encouraging and support the progression of LX4211 into late-stage development for type 1 diabetes."
In this multicenter study, 33 patients with poorly controlled type 1 diabetes on either an insulin pump or multiple insulin injection therapy were randomized 1:1 to receive either placebo or a 400 mg dose of LX4211 orally once per day before breakfast for four weeks. Patients adjusted their insulin as needed, recorded their blood sugars, and then were evaluated at the end of the study for amount of insulin used and glycemic control, as measured by HbA1c, continuous glucose monitors and serum blood glucose measures. Lexicon plans to present full results of the study at a scientific congress.
"An oral agent benefiting patients with type 1 diabetes through both substantial improvements in glucose control and significant reduction in the use of insulin with no increase in hypoglycemia is both new and clinically meaningful," said Pablo Lapuerta, M.D., Lexicon's chief medical officer. "These results provide a strong rationale for demonstrating the effectiveness of LX4211 as an adjunct to insulin in Type 1 diabetes in a longer-term Phase 3 program."
Type 1 diabetes is a serious condition affecting more than one million people in the United States, both children and adults. Type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body's immune system attacks and destroys the insulin-producing cells in the pancreas. Insulin is a required treatment, with few additional treatment options. The effectiveness of insulin is limited by concerns about potentially serious hypoglycemia; therefore, most patients with type 1 diabetes do not achieve their targets for glucose control. In addition, insulin therapy does not necessarily prevent the possibility of the disease's serious complications, which may include kidney failure, blindness, nerve damage, heart attack and stroke. As an oral agent, LX4211 is designed to delay the absorption of glucose in the gastrointestinal tract and enhance glucose excretion in the kidney, allowing glucose control to improve and insulin doses to be reduced.
Lexicon Conference Call
Lexicon management will hold a conference call and webcast to discuss the LX4211 Phase 2 top-line data at 8:30 a.m. Eastern Time on April 14, 2014.
The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international). The conference ID for all callers is 30215299. Investors can access a live webcast of the call at www.lexpharma.com. An archived version of the webcast will be available on Lexicon's corporate website through May 14, 2014.
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon's research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX4211, characterizations of the results of and projected timing of clinical trials of LX4211, and the potential therapeutic and commercial potential of LX4211. The press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Lexicon Pharmaceuticals, Inc.
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 19, 2017 09:00 PM EST Reads: 4,404
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
Jan. 19, 2017 08:45 PM EST Reads: 5,257
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus o...
Jan. 19, 2017 07:30 PM EST Reads: 4,231
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jan. 19, 2017 06:30 PM EST Reads: 6,317
Providing secure, mobile access to sensitive data sets is a critical element in realizing the full potential of cloud computing. However, large data caches remain inaccessible to edge devices for reasons of security, size, format or limited viewing capabilities. Medical imaging, computer aided design and seismic interpretation are just a few examples of industries facing this challenge. Rather than fighting for incremental gains by pulling these datasets to edge devices, we need to embrace the i...
Jan. 19, 2017 05:30 PM EST Reads: 3,630
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Jan. 19, 2017 05:15 PM EST Reads: 3,107
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 19, 2017 05:15 PM EST Reads: 1,314
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 19, 2017 04:45 PM EST Reads: 3,757
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Jan. 19, 2017 04:45 PM EST Reads: 3,478
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 19, 2017 04:15 PM EST Reads: 5,408
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Jan. 19, 2017 04:00 PM EST Reads: 5,434
SYS-CON Events announced today that Catchpoint, a leading digital experience intelligence company, has been named “Silver Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Catchpoint Systems is a leading Digital Performance Analytics company that provides unparalleled insight into your customer-critical services to help you consistently deliver an amazing customer experience. Designed for digital business, C...
Jan. 19, 2017 03:45 PM EST Reads: 1,796
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, will highlight the current challenges of these transformative technologies and share strategies for preparing your organization for these changes. This “view from the top” will outline the latest trends and developm...
Jan. 19, 2017 03:30 PM EST Reads: 1,040
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Jan. 19, 2017 02:15 PM EST Reads: 1,063
@ThingsExpo has been named the ‘Top WebRTC Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @ThingsExpo ranked as the number one ‘WebRTC Influencer' followed by @DevOpsSummit at 55th.
Jan. 19, 2017 02:00 PM EST Reads: 4,788