MDGL stock rose more than 5% in early trading on January 31, 2022, after the company announced blockbuster results of its clinical trial for people with non-alcoholic fatty liver disease.
Positive Topline Phase 3 MAESTRO-NAFLD-1 Data Demonstrate Resmetirom was Safe, Well-Tolerated and Provided Statistically Significant Improvements in Key Measures of Liver and Cardiovascular Health
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), today announced positive topline clinical data from the placebo-controlled, double-blind portion of its Phase 3 MAESTRO-NAFLD-1 (non-alcoholic fatty liver disease) safety study of resmetirom. The 52-week study demonstrated that resmetirom was safe and well-tolerated at 80 and 100 mg once a day dosing. Additionally, resmetirom helped patients with presumed non-alcoholic steatohepatitis (NASH) achieve significant, clinically relevant reductions in liver fat and atherogenic lipids.
“These positive results from the first of our two Phase 3 MAESTRO trials support our conviction that resmetirom has the potential to be the first medication approved for the treatment of patients with NASH and liver fibrosis. The blinded, placebo-controlled data from MAESTRO-NAFLD-1 reinforce previous positive Phase 2 and open-label Phase 3 safety findings in a much larger population of patients followed for 56 weeks. Rigorous safety evaluation is critical in NASH drug development because of the large numbers of patients with NASH that could be treated with a new medication once FDA approved. The large safety database we are generating through the MAESTRO trials supports our regulatory strategy under Subpart H and reflects our commitment to providing the data necessary for overall benefit-risk assessment,” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal.
Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal added, “These positive topline MAESTRO-NAFLD-1 placebo-controlled data are highly encouraging and increase our confidence in the pivotal serial liver biopsy Phase 3 trial, MAESTRO-NASH, that will deliver safety and efficacy data later this year. MAESTRO-NAFLD-1 was conducted during the height of the COVID-19 pandemic. COVID-related visits and blister pack manufacturing interruptions were observed in the study. Despite this, MRI-PDFF reductions were robust, with nearly half of patients in the resmetirom 100 mg arm achieving a 50% PDFF reduction. Importantly, COVID-related issues or patient withdrawals have not had a significant impact in the MAESTRO-NASH serial liver biopsy study.”
Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies commented, “This positive readout from MAESTRO-NAFLD-1 is a significant milestone for the field. As the first Phase 3 study in NASH that does not rely on liver biopsy to identify patients and measure treatment response, MAESTRO-NAFLD-1 will help accelerate the role of non-invasive imaging and biomarkers in NASH drug development. We see a safety and tolerability profile for resmetirom in this study of nearly one thousand patients treated for 52 weeks that, similar to earlier studies, leads to very low adverse event discontinuation rates. We look forward to presenting additional analyses of safety and efficacy data from MAESTRO-NAFLD-1 at future scientific congresses.”
A total of 972 patients were randomized in the double-blind arms of the MAESTRO-NAFLD-1 study: 969 patients were included in the safety population and 943 patients in a modified intent-to-treat population for evaluation of key secondary and other endpoints. Important inclusion criteria included the presence of three risk factors of Metabolic Syndrome, a level of liver fibrosis (measured by FibroScan) consistent with a range of stages of liver fibrosis, and >=8% liver fat (measured by MRI-PDFF). The study remains blinded to study personnel at the individual patient level. Any occurrence of <25 events of an individual safety measurement was also blinded by treatment group.
Resmetirom was safe and well-tolerated at the 80 mg dose and also importantly at the top dose of 100 mg in MAESTRO-NAFLD-1. Adverse events observed in the MAESTRO-NAFLD-1 trial were generally mild to moderate in severity. The frequency of serious adverse events was similar across treatment arms (Table 1) and discontinuation for adverse events was low. Serious adverse events occurred at expected rates based on the patient population.
📺 EASL 2021 – Phase 3 Development of Resmetirom – Q&A
📉 MDGL Stock Technical Analysis
Both the long and short-term trends are negative. It is better to avoid buying stocks with negative trends. MDGL is part of the Biotechnology industry. There are 640 other stocks in this industry, MDGL did better than 64% of them. MDGL is currently trading near the lower end of its 52-week range, which is not a good sign. MDGL is lagging the S&P500 Index which is trading in the middle of its 52-week range. Prices have been falling strongly lately, it is better to avoid new long positions here.
There is a support zone ranging from 55.88 to 56.40. This zone is formed by a combination of multiple trend lines in multiple time frames.
There is resistance at 80.08 from a trend line in the weekly time frame. There is also resistance at 83.13 from a trend line in the weekly time frame.
The technical rating of MDGL is bad and it also does not present a quality setup at the moment. MDGL stock has a Setup Rating of 3 out of 10. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when MDGL stock consolidates and has a Setup Rating of 8 or higher.