Nash lost another point, galectin shares fell 30%

Source: U.S - China drug source December 6, 2017 [news event]: today, the Nash drug and galectin inhibitor gr-md-02 of galectin therapeutics, a biotechnology company, failed to reach the primary end point in a phase II clinic called nash-cx In this study, 161 patients with Nash were enrolled and treated with two doses of gr-md-02 The primary end point was hepatic venous pressure gradient (HVPG, caused by portal hypertension) Gr-md-02 did not reach the primary end point in the whole population, but reached this end point in the esophageal varices subgroup (about 50% of patients) In addition, the low-dose group reached a secondary end point related to fibrosis, but the high-dose group did not reach this end point Although the manufacturer claims that this is the first time that Nash drug shows improvement in fibrosis and portal hypertension in large-scale controlled trials, investors did not buy it because the former has no dose-response relationship and the latter is the result of subgroup analysis Galt fell 50% at one point and ended down 30% [news event]: Nash is one of the hottest new drug research and development fields, but the progress is very slow With the spread of obesity and diabetes, fatty liver also appears in large numbers It is estimated that 25% of the population in the United States has fatty liver Although fatty liver itself is not a good thing, it is the expression of metabolic syndrome in the liver, but Nash is a much more serious subtype About a quarter of fatty liver patients are Nash, which is the most important risk factor for cirrhosis and liver cancer after hepatitis C is gradually cured In the United States alone, it causes a loss of 100 billion US dollars every year Although all patients with Nash have fatty liver, there are no other indicators to predict which quarter of patients with fatty liver will become Nash except for fibrosis, while some patients with Nash can self heal Triglyceride (TG) itself may be very toxic, because its synthetic precursor or metabolite is the real inducing factor of Nash, but these toxic substances have not been found Of course, TG is only one of the factors that induce Nash, and only other factors that have not been understood now can be converted into Nash So although Nash is in the background of fatty liver, how much mechanism between TG and Nash is unknown It is also likely to be a highly heterogeneous disease, and our understanding of it is still very early This is also the core reason why Nash new drug research and development is struggling Galectin is a kind of protein with complex functions, which is related to fibrosis, cell proliferation and inflammation Gr-md-02 is a galectin-3 inhibitor, which can alleviate the disease in the chemical induced liver fibrosis animal model, and the fibrosis in galectin knockout mice is less than that in the wild type Despite the support of genetics and animal experiments, gr-md-02 failed in a phase II clinical trial with fibrosis as the main end point last year Today's failure not only evaporates the market value of GALT, but also their cash reserves are said to be only $2 million Survival has become a problem Another biotech company based on galectin is galecto in Denmark A few years ago, galectin inhibitor td139 was jointly developed with Squibb for pulmonary fibrosis Because the pathogenesis of Nash is complex and there are many unknown factors, the development of new drugs is blind The most advanced is ocept's OCA, and now the third phase is in progress Although OCA improved fibrosis in the second phase, it increased LDL level A while ago, it was found that high dose caused severe liver injury in PBC patients Gs-0976, the allosteric ACC2 inhibitor of Gilead, also alleviates liver fibrosis, but causes the rise of blood triglycerides Therefore, MSD has given up the development of similar drugs in NASH Genfit's gft505 failed in a phase II clinical trial the year before Gilead also terminated the LOXL2 inhibitor simtuzumab last year, but its ASK1 inhibitor selonsertib is considered to be the most promising Nash drug Nash new drug development is like changing a part of a huge and unknown Rube Goldberg machine, hoping to change the output of the machine, and the success rate can be imagined.