|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
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 05:30 PM EDT Reads: 1,702
"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.
Jul. 23, 2016 05:30 PM EDT Reads: 1,518
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud. Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
Jul. 23, 2016 05:30 PM EDT Reads: 1,952
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
Jul. 23, 2016 05:15 PM EDT Reads: 634
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Jul. 23, 2016 05:00 PM EDT Reads: 924
"Operations is sort of the maturation of cloud utilization and the move to the cloud," explained Steve Anderson, Product Manager for BMC’s Cloud Lifecycle Management, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 05:00 PM EDT Reads: 1,778
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Jul. 23, 2016 04:45 PM EDT Reads: 888
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Jul. 23, 2016 04:30 PM EDT Reads: 662
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
Jul. 23, 2016 04:00 PM EDT Reads: 1,801
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Jul. 23, 2016 04:00 PM EDT Reads: 1,963
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
Jul. 23, 2016 04:00 PM EDT Reads: 2,292
What are the successful IoT innovations from emerging markets? What are the unique challenges and opportunities from these markets? How did the constraints in connectivity among others lead to groundbreaking insights? In her session at @ThingsExpo, Carmen Feliciano, a Principal at AMDG, will answer all these questions and share how you can apply IoT best practices and frameworks from the emerging markets to your own business.
Jul. 23, 2016 03:45 PM EDT Reads: 1,490
Basho Technologies has announced the latest release of Basho Riak TS, version 1.3. Riak TS is an enterprise-grade NoSQL database optimized for Internet of Things (IoT). The open source version enables developers to download the software for free and use it in production as well as make contributions to the code and develop applications around Riak TS. Enhancements to Riak TS make it quick, easy and cost-effective to spin up an instance to test new ideas and build IoT applications. In addition to...
Jul. 23, 2016 03:30 PM EDT Reads: 1,828
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 23, 2016 03:15 PM EDT Reads: 784
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, discussed how a cloud designed for production operations not only helps accelerate developer in...
Jul. 23, 2016 03:00 PM EDT Reads: 1,178