Wired News – Madrigal Pharma Reported Encouraging Top-line Data at 36 Weeks from Phase-2 Clinical Trial of MGL-3196 in Patients with NASH

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LONDON, UK / ACCESSWIRE / June 4, 2018 / If you want access to our free research report on Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=MDGL as the Company’s latest news hit the wire. On May 31, 2018, the Company announced positive top-line, 36-week results from a Phase-2 clinical trial assessing MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β-selective agonist, in patients with biopsy-proven non-alcoholic steatohepatitis (NASH). Register today and get access to over 1,000 Free Research Reports by joining our site below:

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MGL-3196 Demonstrated Statistical Significance in the Primary Endpoint

In this trial, MGL-3196 demonstrated statistical significance in the primary endpoint, relative reduction of liver fat on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12 Weeks in December 2017 and reported statistically significant results in multiple Week 36 endpoints including key secondary endpoints, reduction and resolution of NASH. The study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included 25 clinical sites in the United States.

MGL-3196 treated patients with ≥ 30% fat reduction on MRI-PDFF at Week 12 demonstrated a higher percentage of NAS reduction and NASH resolution. In patients with NASH Resolution, 35% of MGL-3196 treated and no placebo patients had baseline NAS ≥5. In MGL-3196 patients with NASH resolution, fibrosis also resolved in 50% of patients and was decreased statistically significantly. Sustained, highly statistically significant reduction in liver fat compared with placebo on Week 36 MRI-PDFF was observed. MGL-3196 was well-tolerated with mostly mild and a few moderate adverse effects (AEs) and seven severe adverse effects (SAEs).

Madrigal to Advance MGL-3196 in a Phase-3 Clinical Trial in Patients with NASH

Commenting on the announcement, Becky Taub, M.D., CMO and Executive VP – Research & Development of Madrigal, stated that the Company is pleased with the results of this study that demonstrate that MGL-3196 has the potential to show a clear benefit in patients with NASH, including both reduction and resolution of NASH and improvement in multiple atherogenic lipids.

Becky added that cardiovascular disease is the primary reason for death in patients with NASH. Madrigal looks forward to advancing MGL-3196 in a Phase-3 clinical trial in patients with NASH.

Post announcement of the news, shares of the Company surged in pre-market trade.

About Non-Alcoholic Steatohepatitis

NASH is a common liver disease in the United States and worldwide, unrelated to alcohol use, that is characterized by a build-up of fat in the liver, inflammation, damage (ballooning) of hepatocytes and increasing fibrosis. Although people with NASH may feel well and often do not know they have the disease, NASH can lead to permanent damage, including cirrhosis and impaired liver function in a high percentage of patients.

About MGL-3196

MGL-3196 is a first-in-class, orally administered, small-molecule, liver-directed, THR β-selective agonist. Preclinical, toxicology and Phase-1 clinical data suggest MGL-3196 has an attractive, differentiated profile as a potential treatment for NASH and dyslipidemias. THR-β selectivity also enhances the safety profile of MGL-3196, compared to non-selective agents. MGL-3196 has shown no suppression of the central thyroid axis, no THR-α effects on heart rate or bone, and no elevation of liver enzymes. These characteristics make MGL-3196 among the most promising molecules in development in this therapeutic area.

About Madrigal Pharmaceuticals, Inc.

Founded in 2011 and headquartered in Fort Washington, Pennsylvania, Madrigal Pharma is developing novel, high-quality small-molecule drugs addressing major unmet needs in cardiovascular and metabolic diseases. The Company is targeting treatment of both niche and prevalent indications, including fatty liver disease and NASH, diabetes, dyslipidemia, and cardiovascular disease.

Stock Performance Snapshot

June 01, 2018 – At Friday’s closing bell, Madrigal Pharma’s stock climbed 3.32%, ending the trading session at $274.42.

Volume traded for the day: 1.37 million shares, which was above the 3-month average volume of 337.09 thousand shares.

Stock performance in the last month – up 143.00%; previous three-month period – up 109.67%; past twelve-month period – up 1695.94%; and year-to-date – up 198.97%

After last Friday’s close, Madrigal Pharma’s market cap was at $3.78 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.0% at the end of the session.

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