Madrigal Pharmaceuticals stock (NASDAQ:MDGL) has been skyrocketing. Why is Madrigal Pharmaceuticals stock moving with such gusto, and just how great is the rise? Take a look at the chart of Madrigal Pharmaceuticals stock:
The stock has been in rally mode because there is a real possibility that the company will receive approval for an upcoming drug. However, there are more trial data expected. Based on the data that was announced in December, investors are pushing the stock up up up. Was the data really that good?
Well, based on results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH), the short answer is YES. NASH is a common liver disease in the United States, with a growing prevalence, for which no FDA approved treatment is yet available. A highly selective liver-directed, thyroid hormone receptor-β agonist may be able to effectively and safely treat patients with NASH.
In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β -selective agonist, demonstrated statistically significant results for the primary endpoint, the percent change in hepatic fat versus placebo as measured by MRI-PDFF, a non-invasive imaging test. Recent published data have shown a high correlation of the reduction of liver fat of 30% or more as measured by MRI-PDFF to improvement in NASH on liver biopsy.
Here are the results. Take a look at how significant the p-values are here. Anything less than .05 is considered statistically significant:
|ALL MGL-3196||HIGH MGL-3196**||Placebo|
|Numbers of patients||78||44||38|
|Relative change in MRI-PDFF (% change from baseline, median)
Significance relative to placebo
|Percentage of patients attaining ≥30% liver fat reduction
Significance relative to placebo
**Prespecified group of patients (44/78) with relatively higher MGL-3196 drug levels
Statistically significant reductions in ALT and AST were observed in MGL-3196 treated patients; greater reductions in ALT and AST, statistically significant relative to placebo, were observed in the prespecified group of 44/78 patients with relatively higher MGL-3196 drug levels. In drug-treated relative to placebo patients, statistically significant improvements were also seen in multiple secondary endpoints considered to be potentially clinically relevant in patients with NASH including LDL-C, triglycerides, apolipoprotein B (ApoB), and Lp(a).
MGL-3196 has been well-tolerated with mostly mild AEs, and a few moderate AEs, the numbers of which are balanced between placebo and drug-treatment groups. There are no adverse effects of MGL-3196 on safety laboratory or vital sign parameters. There have been three serious adverse effects in the study, all considered unrelated to MGL-3196.
The on-going study remains blinded. Safety, efficacy of NASH resolution by biopsy, and repeat MRI-PDFF will be assessed at 36 weeks. Multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks are being and will be assessed.
Results from this study confirm what preclinical and earlier clinical studies showed and give us confidence in the safety and potential therapeutic value of MGL-3196.
We fully expect data at 36 weeks to confirm results seen at 12 weeks. We look forward to the presentation of the 12-week, Phase 2 results to the scientific and clinical community, and further development of MGL-3196 for treatment of patients with NASH.
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