|By PR Newswire||
|June 22, 2013 11:00 AM EDT||
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
- 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
- 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
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and microservices. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your conta...
Oct. 28, 2016 08:00 AM EDT Reads: 1,640
Personalization has long been the holy grail of marketing. Simply stated, communicate the most relevant offer to the right person and you will increase sales. To achieve this, you must understand the individual. Consequently, digital marketers developed many ways to gather and leverage customer information to deliver targeted experiences. In his session at @ThingsExpo, Lou Casal, Founder and Principal Consultant at Practicala, discussed how the Internet of Things (IoT) has accelerated our abil...
Oct. 28, 2016 08:00 AM EDT Reads: 3,505
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Oct. 28, 2016 08:00 AM EDT Reads: 5,085
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, will discuss how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team a...
Oct. 28, 2016 08:00 AM EDT Reads: 907
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 28, 2016 08:00 AM EDT Reads: 1,066
SYS-CON Events announced today that Streamlyzer will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
Oct. 28, 2016 07:15 AM EDT Reads: 1,114
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Oct. 28, 2016 07:15 AM EDT Reads: 1,118
Intelligent machines are here. Robots, self-driving cars, drones, bots and many IoT devices are becoming smarter with Machine Learning. In her session at @ThingsExpo, Sudha Jamthe, CEO of IoTDisruptions.com, will discuss the next wave of business disruption at the junction of IoT and AI, impacting many industries and set to change our lives, work and world as we know it.
Oct. 28, 2016 07:00 AM EDT Reads: 590
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Oct. 28, 2016 07:00 AM EDT Reads: 3,753
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 28, 2016 07:00 AM EDT Reads: 1,171
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Oct. 28, 2016 06:45 AM EDT Reads: 1,263
DevOps theory promotes a culture of continuous improvement built on collaboration, empowerment, systems thinking, and feedback loops. But how do you collaborate effectively across the traditional silos? How can you make decisions without system-wide visibility? How can you see the whole system when it is spread across teams and locations? How do you close feedback loops across teams and activities delivering complex multi-tier, cloud, container, serverless, and/or API-based services?
Oct. 28, 2016 06:30 AM EDT Reads: 1,191
Today every business relies on software to drive the innovation necessary for a competitive edge in the Application Economy. This is why collaboration between development and operations, or DevOps, has become IT’s number one priority. Whether you are in Dev or Ops, understanding how to implement a DevOps strategy can deliver faster development cycles, improved software quality, reduced deployment times and overall better experiences for your customers.
Oct. 28, 2016 06:30 AM EDT Reads: 1,066
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...
Oct. 28, 2016 06:15 AM EDT Reads: 1,306
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 28, 2016 06:00 AM EDT Reads: 2,200