2019165438+126 October, Aberdeen, Scotland and Singapore-In a paper published online in the Journal of Alzheimer's Disease today, TauRx reported the therapeutic dose, the blood concentration of 1000 patients with mild and moderate Alzheimer's disease and the level of methyl methionine. These results show that the drug has a concentration-dependent effect on cognitive decline and brain atrophy even at the lowest dose tested in two phase III global clinical trials.
As a tablet, hydroxymethylmethionine is the non-proprietary name of TauRx, formerly known as LMTM, and approved by WHO. The drug can block the abnormal aggregation of tau protein in the brain, and tau protein has been increasingly regarded as an important driving factor of clinical dementia. In the phase III global clinical trial of 20 12 to 20 12 and 1700 patients with mild and moderate Alzheimer's disease, the experimental dose of methyl methionine was 150-250mg/ day, while the low dose was 8mg/ day. This research design is based on the early experimental results, which used different variants of the drug. Surprisingly, there is no difference between high-dose and low-dose HMT in any clinical results of this trial. 4,5
In order to further explore these results, the researchers used the plasma concentration data of 1 and 162 patients who participated in either of the two completed phase 3 hydroxymethylmethionine trials, and conducted a new pharmacokinetic population analysis to measure the relationship between the blood level of the drug and its impact on the brain. Using a new determination method, the researchers found that the effect of methionine at a dose of 8 mg/day is determined by the blood concentration, and most patients have a high enough blood concentration at this dose, which may lead to a significant decline in cognitive ability. Decline and brain atrophy. They concluded that a slightly higher dose of methionine 16mg/ day can ensure that the blood drug concentration of all patients reaches the level needed to maximize the drug action, because its action reaches a steady state at a higher concentration and dose. They found that many drugs have typical pharmacokinetic characteristics, which can now explain why the pharmacological effect of high-dose hydroxymethylmethionine tested in the experiment is not better than that of 8 mg/day seen in hyperlipidemia patients.
The analysis also shows that although the concentration-response curve of HMM is similar in patients who take HMM as an adjuvant therapy for conventional symptomatic treatment of Alzheimer's disease, the maximum curative effect of these patients is reduced by half. This discovery supports the hypothesis that symptomatic drugs for this situation will interfere with hydroxymethylmethionine to improve the therapeutic effect of the disease. This hypothesis was originally put forward based on the results of phase 3 trials of the drug. 4,5
"Because we already have an important database to support the safety and tolerability of methionine in the clinical trials of patients with mild to moderate Alzheimer's disease, other results of this analysis give us confidence to expand the scope of the new TauRx sober clinical study, which confirms the potential efficacy of 16 mg of methionine per day for these types of patients," said Cod Weischik, a professor at Aberdeen University and executive chairman of TauRx Therapeutics Ltd
He pointed out that taking hydroxymethylmethionine in a convenient oral form at home is different from other treatments for Alzheimer's disease currently in clinical trials, and it does not require patients to go to the clinic for intravenous infusion or injection.
He added: In addition to reducing brain atrophy, we were surprised to find that in the patient population, the treatment of high concentration of hydroxymethylmethionine in 8 mg of blood every day has great cognitive effect. According to the score of ADAS-cog scale, its effect is about 7.5 points, which is three times that of the current conventional treatment for Alzheimer's disease, which is equivalent to an 85% decline in cognitive ability within 65 weeks. The cognitive subscale of the Alzheimer's disease assessment scale is a standard cognitive scale for measuring neuropsychological changes in clinical trials of Alzheimer's disease. It is generally believed that the four changes indicate clinically significant differences.
Professor George Perry, editor-in-chief of the Journal of Alzheimer's Harmo's Disease, commented: Extensive data, experience and current pharmacokinetics highlight the potential of hydroxymethylmethionine therapy as an important new method for Alzheimer's Harmo's disease. Brain atrophy greatly exceeds the reports of other treatment methods.
Professor Serge Gauthier, director of the Alzheimer's disease research group at McGill Aging Research Center, commented: The purpose of the researchers is to confirm the results found in the placebo-controlled trials currently under way. Methionine is the best hope. We now have a disease-relieving drug, which can treat the tau pathology associated with Alzheimer's disease.
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