Click here to close now.




















Welcome!

News Feed Item

Elcelyx Therapeutics Reports Positive Data for NewMet in Type 2 Diabetes at 2013 American Diabetes Association Scientific Sessions

Study Reveals Groundbreaking Understanding of Metformin Mechanism of Action

SAN DIEGO, June 22, 2013 /PRNewswire/ -- Elcelyx Therapeutics announced today that clinical study results confirm that the primary site of action of Type 2 diabetes medicine metformin is in the lower bowel rather than in the circulation. The study revealed that contrary to popular belief, greater exposure in the plasma of metformin does not improve efficacy of the most prescribed diabetes medicine in the world. Elcelyx's Phase 2a study demonstrated this by comparing the glucose-lowering effects of NewMet™, the company's proprietary delayed-release formulation of metformin, to generic metformin in patients with Type 2 diabetes.

NewMet is formulated to target the entire dose to the lower bowel and limit absorption into the blood. In the crossover study, 5-day treatment with NewMet had similar fasting and post-meal glucose reductions from baseline as 5-day treatment with generic metformin despite greater than 45% reductions in metformin plasma concentrations. In addition, NewMet had less gastrointestinal (GI) side effects than generic metformin. Results of the clinical trial will be presented at ADA on Sunday by Dr. Ralph DeFronzo, Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and the Audie L. Murphy Memorial Veterans Administration Hospital in San Antonio, Texas.

The significantly lower metformin plasma concentration observed with NewMet suggests that it might be safely used by patients with moderate and severe renal impairment, a population of patients that is unable to use currently available metformin formulations due to the risk of lactic acidosis caused by too much metformin in the blood. Mark Fineman, Ph.D., Senior Vice President of Research & Development at Elcelyx will present a second poster, accepted as a late-breaker that describes a model designed to predict concentrations of metformin in the blood that would occur if patients with Type 2 diabetes and mild, moderate or severe renal impairment were to take NewMet. The results of the model suggest that patients with renal impairment taking effective doses of NewMet would not have an increased risk of lactic acidosis caused by accumulation of metformin in the blood. Elcelyx will be initiating a pharmacokinetic study this summer in Type 2 diabetes patients with mild, moderate and severe renal impairment to confirm the predictions of the model.

"Metformin is the preferred initial pharmacological agent for Type 2 diabetes, but in the U.S., 40% of patients with diabetes are not taking it primarily due to issues of GI tolerability or due to the contraindication of their renal impairment. Moreover, of the 60% who are taking metformin, only about 40% are able to titrate to fully effective doses due to tolerability issues," said John Buse, M.D., Professor of Medicine and Director, Diabetes Care Center, Chief, Division of Endocrinology, Executive Associate Dean for Clinical Research at University of North Carolina School of Medicine, Chapel Hill, North Carolina. "The NewMet results to date hold the promise of addressing all these patient segments. This is very encouraging news for physicians who would like to be in compliance with ADA treatment guidelines and have their patients benefit from metformin therapy." Dr. Buse was an advisor on the Phase 2a NewMet clinical study.

To confirm results observed to date, a multicenter, double-blind dose-finding Phase 2b trial evaluating NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo is underway.  There are also two comparator arms with generic extended-release metformin dosed once-daily at 1,000 and 2,000 milligrams. The primary endpoint of the study is fasting plasma glucose at four weeks of treatment. Secondary endpoints through 12 weeks include changes in fasting plasma glucose, hemoglobin A1c, body weight and measures of safety and tolerability. The study is fully enrolled with 240 patients with Type 2 diabetes.

Phase 2a Study Details
The randomized, double-blind, three-way crossover study compared the pharmacokinetics and pharmacodynamics of NewMet to generic metformin in patients with Type 2 diabetes. Twenty-four patients were randomized to receive twice-daily oral dosing of metformin HCl immediate release (1,000 mg), low dose NewMet (500 mg), and high dose NewMet (1,000 mg) for five days each separated by a one week washout. All treatments demonstrated similar reductions from baseline values in fasting plasma glucose (16-22 mg/dL, p<0.01 for all) and postprandial glucose (8%-12%, p<0.001 for all) despite a 45%-57% reduction in circulating metformin in the high and low dose NewMet arms, respectively. Gut hormones (GLP-1 and PYY) were increased similarly by more than 50% across all treatments. No safety concerns were noted for either NewMet or metformin.

Elcelyx Therapeutics' Posters at ADA: Links to Abstracts

Dissociation between metformin plasma exposure and its glucose-lowering effect: A novel gut-mediated mechanism of action

  • Date and Time: Sunday, June 23, 2013, 12:00 p.m. to 2:00 p.m. CT
  • Poster #, Category:  1087-P, 01-D Clinical Therapeutics/New Technology – Oral Agents

Delayed-release metformin may be suitable for use in diabetes patients with renal impairment that are contraindicated for currently available metformin formulations

  • Date and Time: Sunday, June 23, 2013, 12:00 p.m. to 2:00 p.m. CT
  • Poster #, Category:  75-LB, 01-D Clinical Therapeutics/New Technology – Oral Agents

About Elcelyx Therapeutics
Elcelyx Therapeutics develops pharmaceutical and consumer healthcare products based on its proprietary Gut Sensory Modulation (GSM) platform. Pharmaceutical product candidate NewMet™ is being developed for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated for its use. In the consumer health area, Elcelyx is developing Lovidia™ as a dietary supplement for weight management. These product candidates are backed by rigorous science and clinical data and present near-term, blockbuster commercial opportunities.  Elcelyx is based in San Diego, CA. For more information, visit www.Elcelyx.com.

SOURCE Elcelyx Therapeutics

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
A producer of the first smartphones and tablets, presenter Lee M. Williams will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. In his session at @ThingsExpo, Lee Williams, COO of ETwater, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ET...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
Cloud and datacenter migration innovator AppZero has joined the Microsoft Enterprise Cloud Alliance Program. AppZero is a fast, flexible way to move Windows Server applications from any source machine – physical or virtual – to any destination server, in any cloud or datacenter, using its patented container technology. AppZero’s container is also called a Virtual Application Appliance (VAA). To facilitate Microsoft Azure onboarding, AppZero has two purpose-built offerings: AppZero SP for Azure,...
WSM International, the pioneer and leader in server migration services, has announced an agreement with WHOA.com, a leader in providing secure public, private and hybrid cloud computing services. Under terms of the agreement, WSM will provide migration services to WHOA.com customers to relocate some or all of their applications, digital assets, and other computing workloads to WHOA.com enterprise-class, secure cloud infrastructure. The migration services include detailed evaluation and planning...
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
IBM’s Blue Box Cloud, powered by OpenStack, is now available in any of IBM’s globally integrated cloud data centers running SoftLayer infrastructure. Less than 90 days after its acquisition of Blue Box, IBM has integrated its Blue Box Cloud Dedicated private-cloud-as-a-service into its broader portfolio of OpenStack® based solutions. The announcement, made today at the OpenStack Silicon Valley event, further highlights IBM’s continued support to deliver OpenStack solutions across all cloud depl...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
SYS-CON Events announced today the Containers & Microservices Bootcamp, being held November 3-4, 2015, in conjunction with 17th Cloud Expo, @ThingsExpo, and @DevOpsSummit at the Santa Clara Convention Center in Santa Clara, CA. This is your chance to get started with the latest technology in the industry. Combined with real-world scenarios and use cases, the Containers and Microservices Bootcamp, led by Janakiram MSV, a Microsoft Regional Director, will include presentations as well as hands-on...
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes ab...