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Biotech / Medical : momo-T/FIF

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To: Miljenko Zuanic who wrote (11569)6/1/2018 9:07:00 AM
From: Biotech Jim  Read Replies (2) of 12215
 
Thanks, Rick and Miljenko for the comments. I became aware of MDGL in the March/April 2017 time frame, and bought my first shares in mid April 2017. Low volume trading, very few understood what MDGL and Becky Taub had discovered at Roche.

Note that patent life for MGL-3196 is somewhat limited.

Miljenko, do you have a value in mind for VKTX? I sold all my VKTX yesterday, but will come back at some point.

Thanks also to Karo Bio for their pioneering work on THbeta agonists for obesity, a company I followed in the distant past. The following was from a KOL in the NASH field.

"Eprotirome, or KB2115. Among all thyromimetics, eprotirome is the only drug candidate that reached Phase III testing. The compound is thyroid hormone receptor ß-selective and demonstrated liver targeting properties. In a randomized, double-blind Phase I study with 24 obese subjects, treatment with eprotirome for two weeks was shown to reduce serum cholesterol up to 40% and apolipoprotein B, which is a component of many lipoproteins and could be a biomarker for the risk of atherosclerosis, without negative cardiac effects. With the encouraging data, Karo Bio initiated two Phase II studies focused on monotherapy and in combination with statins in hypercholesterolemia. The 189-patient Phase II statin combination study mostly mirrored the results from the Phase I monotherapy study in efficacy (reduced cholesterol and apolipoprotein B levels) and safety (no observed cardiotoxicity) in 12 weeks. However, a mild transient elevation in alanine aminotransferase levels was detected.


In the 98-patient, 12-week Phase II monotherapy trial, serum LDL cholesterol was reduced by 23% in the lower 100 µg dose group and by 30% in the higher 200 µg dose cohort, which relative to the Phase I study were smaller in magnitude. Similar to the combination trial, low-grade liver enzyme elevation was noted in the majority of enrolled patients, which in our view is signi??icant because it demonstrated that eprotirome alone is suf??icient to cause potential liver damage. Eventually, the Phase III AKKA trial, a double-blind, placebo-controlled study that enrolled 236 patients, was initiated to con??irm previous ??indings. From the ef??icacy side, LDL cholesterol was reduced by 22% for the higher 100 µg dose, a performance that closely matched the Phase II monotherapy study, and by 12% for the lower 50 µg dose. Lipid measurements such as apolipoprotein B, triglycerides, and lipoprotein(a) all experienced signi??icant reductions following eprotirome treatment. Unfortunately, the liver enzyme elevation observed in the Phase II studies reappeared in the AKKA trial as aspartate aminotransferase and alanine aminotransferase levels spiked significantly by 114% and 189%, respectively. In addition, a canine safety study suggested eprotirome could cause cartilage damage. As a result, the AKKA study was terminated and Karo Bio decided to cease any further clinical development of eprotirome."
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