|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
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 5, 2016 04:15 PM EST Reads: 844
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Dec. 5, 2016 04:00 PM EST Reads: 2,546
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 03:45 PM EST Reads: 4,235
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 5, 2016 03:45 PM EST Reads: 255
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 5, 2016 03:45 PM EST Reads: 2,029
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Dec. 5, 2016 02:45 PM EST Reads: 3,274
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 5, 2016 02:45 PM EST Reads: 1,582
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 5, 2016 02:45 PM EST Reads: 665
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU's GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes. In...
Dec. 5, 2016 02:15 PM EST Reads: 1,095
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, 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.
Dec. 5, 2016 02:00 PM EST Reads: 2,198
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...
Dec. 5, 2016 01:45 PM EST Reads: 1,706
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Dec. 5, 2016 01:15 PM EST Reads: 2,161
"Coalfire is a cyber-risk, security and compliance assessment and advisory services firm. We do a lot of work with the cloud service provider community," explained Ryan McGowan, Vice President, Sales (West) at Coalfire Systems, Inc., in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 01:00 PM EST Reads: 841
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
Dec. 5, 2016 12:45 PM EST Reads: 680
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 @...
Dec. 5, 2016 12:34 PM EST Reads: 246