|By Marketwired .||
|November 6, 2012 12:30 PM EST||
FORT WASHINGTON, PA -- (Marketwire) -- 11/06/12 -- Madrigal Pharmaceuticals, a development company focused on novel small-molecule drugs addressing major unmet needs in cardiovascular and metabolic diseases, today announced that results from single and multiple dose Phase I clinical trials of the Company's lead product candidate, MGL-3196, were presented at the American Heart Association 2012 Scientific Sessions, taking place November 3-7 in Los Angeles, California.
In the single dose study, MGL-3196 appeared safe and was well-tolerated at all doses tested. The Phase I multiple dose, proof of concept study enrolled 48 healthy volunteers with mildly elevated LDL cholesterol to evaluate the safety, pharmacokinetics and pharmacodynamics of MGL-3196 after two weeks of daily dosing. Results showed that MGL-3196 was well tolerated and appeared safe at all doses tested. Few adverse events were reported and were generally mild, unrelated to study drug and not dose-related. Daily doses of 50-200 mg showed highly statistically significant reductions, relative to placebo, in LDL-cholesterol of up to 30% (p=.05- < .0001); 28% for non-HDL cholesterol (p=.027-.0001); and 24% for Apolipoprotein B (p=.008-.0004), in addition to strong trends for an up to 60% reduction in triglycerides (p=.13-.016).
MGL-3196 is a liver-directed thyroid hormone receptor-beta (THR-ß) agonist for the treatment of hypercholesterolemia, or high blood cholesterol levels, other dyslipidemias and high triglycerides. It is designed to specifically target receptors in the liver involved in triglyceride metabolism and cholesterol regulation, delivering the validated benefits of THR-ß agonism, which include a lowering of LDL cholesterol, liver triglycerides and triglycerides, while avoiding the side effects associated with receptor activation outside the liver. MGL-3196 has excellent safety in comparative studies with other THR agonists tested previously because of its high liver uptake and high ß-selectivity, with nearly complete lack of THR-a activity.
"These results suggest that MGL-3196 has a unique lipid lowering profile as compared with other agents, with the potential to significantly reduce cholesterol, triglycerides and liver triglycerides. And unlike other thyroid hormone ß-agonists, MGL-3196 is also well tolerated," said Rebecca Taub, M.D., Chief Executive Officer of Madrigal Pharmaceuticals. "Elevated cholesterol, triglycerides and fatty liver are an underlying cause of many metabolic and cardiovascular diseases, which, themselves, are associated with increased mortality. Our next step is to move into disease directed studies where control of these lipid levels in the blood and liver, particularly triglycerides, is clinically important and measurable -- areas such as diabetes with associated fatty liver disease or patients whose very high triglyceride levels put them at elevated risk for pancreatitis and heart disease. We are considering clinical development paths in which large cardiovascular outcome studies may not be required for drug approval."
MGL-3196 is an orally administered, small-molecule ß-selective THR agonist designed to specifically target receptors in the liver involved in metabolism and cholesterol regulation, and avoid side effects associated with thyroid hormone receptor activation outside the liver, including those mediated by THR-a receptors. Based on preclinical studies, MGL-3196 is a potent regulator of hepatic triglyceride metabolism and cholesterol lowering. Preclinical studies demonstrated a rapid reduction of non-HDL cholesterol and the drug was shown to be synergistic with statins in animal studies. THR-ß agonists are believed to promote reverse cholesterol metabolism by causing increased uptake of cholesterol into the liver and increased cholesterol elimination from the body through excretion into the bile. The compound also reduces triglycerides in the plasma and liver by increasing fat metabolism and shows an anti-diabetic action.
About Madrigal Pharmaceuticals, Inc.
Madrigal Pharmaceuticals, Inc. is a company focused on the development of novel compounds for the treatment of cardiovascular and metabolic diseases. Madrigal's drug candidates include MGL-3196 and other compounds that address the underlying causes of metabolic and cardiovascular disease: high cholesterol, triglycerides and diabetes. For more information, visit: http://www.madrigalpharma.com.
Madrigal Pharmaceuticals, Inc.
Rebecca Taub, M.D.
Chief Executive Officer
As businesses adopt functionalities in cloud computing, it’s imperative that IT operations consistently ensure cloud systems work correctly – all of the time, and to their best capabilities. In his session at @BigDataExpo, Bernd Harzog, CEO and founder of OpsDataStore, will present an industry answer to the common question, “Are you running IT operations as efficiently and as cost effectively as you need to?” He will expound on the industry issues he frequently came up against as an analyst, and...
Feb. 23, 2017 12:00 AM EST Reads: 1,585
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Feb. 22, 2017 10:45 PM EST Reads: 564
"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.
Feb. 22, 2017 09:45 PM EST Reads: 6,662
SYS-CON Events announced today that CA Technologies has been named "Platinum 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, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Feb. 22, 2017 08:45 PM EST Reads: 1,816
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 22, 2017 08:45 PM EST Reads: 1,358
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...
Feb. 22, 2017 08:45 PM EST Reads: 1,289
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Feb. 22, 2017 07:45 PM EST Reads: 7,789
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 22, 2017 07:30 PM EST Reads: 1,182
WebRTC sits at the intersection between VoIP and the Web. As such, it poses some interesting challenges for those developing services on top of it, but also for those who need to test and monitor these services. In his session at WebRTC Summit, Tsahi Levent-Levi, co-founder of testRTC, reviewed the various challenges posed by WebRTC when it comes to testing and monitoring and on ways to overcome them.
Feb. 22, 2017 06:30 PM EST Reads: 7,489
Every successful software product evolves from an idea to an enterprise system. Notably, the same way is passed by the product owner's company. In his session at 20th Cloud Expo, Oleg Lola, CEO of MobiDev, will provide a generalized overview of the evolution of a software product, the product owner, the needs that arise at various stages of this process, and the value brought by a software development partner to the product owner as a response to these needs.
Feb. 22, 2017 06:15 PM EST Reads: 1,537
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 22, 2017 05:45 PM EST Reads: 1,384
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
Feb. 22, 2017 04:45 PM EST Reads: 960
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Feb. 22, 2017 04:30 PM EST Reads: 1,088
In the first article of this three-part series on hybrid cloud security, we discussed the Shared Responsibility Model and examined how the most common attack strategies persist, are amplified, or are mitigated as assets move from data centers to the cloud. Today, we’ll look at some of the unique security challenges that are introduced by public cloud environments. While cloud computing delivers many operational, cost-saving and security benefits, it takes place in a public, shared and on-demand ...
Feb. 22, 2017 04:00 PM EST Reads: 1,511
In his session at @ThingsExpo, Sudarshan Krishnamurthi, a Senior Manager, Business Strategy, at Cisco Systems, will discuss how IT and operational technology (OT) work together, as opposed to being in separate siloes as once was traditional. Attendees will learn how to fully leverage the power of IoT in their organization by bringing the two sides together and bridging the communication gap. He will also look at what good leadership must entail in order to accomplish this, and how IT managers ca...
Feb. 22, 2017 03:45 PM EST Reads: 1,535