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Alzheimer's disease (AD) has been listed as one of the three most expensive diseases.
multinational pharmaceutical companies such as Lilly and Yan Jian invest billions of dollars a year in research into the disease, but efforts to effectively treat the disease and hopes of a cure have been dashed time and time again.
week, another biopharmaceutical company announced the disappointing news that their trials had not had an impact on AD's devastating progress.
third generation of Biohaven pharmaticals is expected to regulate the body's most abundant excitable neurotransmitter glutamate.
the drugmaker hopes to find positive effects on troriluzole in a variety of adaptations, so it has conducted extensive evaluation studies of GAD, obsessive compulsive disorder, spinal small brain disorders and AD.
Unfortunately, in the focused analysis of completed troriluzole as the primary and critical secondary data for phase 2/3 clinical trials for the treatment of mild and moderate AD symptoms, there was no statistical improvement in the use of trorilule at 48 weeks in patients using the Alzheimer's Assessment Scale Cognitive Subscale 11 (ADAS cog) and the Total Clinical Dementia Assessment Scale Box (CDR-SB) compared to the placebo group.
primary secondary endpoint, the sea mass was assessed by magnetic resonance imaging (MRI) throughout the population, and troriluzole was no different from the placebo group.
But a subgroup analysis of only mild AD patients showed that troriluzole showed no significant numerical differences in potential benefits on ADAS cog and hema volume MRI at week 48.
in patients with mild AD treated with Troriluzole (n-48), the average deformation change was -1.1% compared to the baseline value in the 48th week, and the deformation change in the placebo group patients (n-49) was -1.6% (difference -0.5%, p-value was 0.2).
Although the numerical effects of ADAS cog and haima MRI in mild AD patients suggest that troriluzole has potential biological effects in patients with early-stage diseases, additional analytical and biomarker data will provide information and help determine whether further research on early AD is needed.
complete results, including additional secondary and exploratory results, biomarkers and subgroup analysis, such as neural filament light chains (NfL), neuroparticle proteins, tau and amyloid proteins, are expected to be published in the coming months.
about safety and toerability, the 280 mg dose of troriluzole treatment once a day is relatively good and has been shown to be consistent with previous studies.
Biohaven plans to collect more clinical and biomarker data by revising the ongoing long-term expansion of the troriluzole treatment AD to enable patients with mild AD to continue treatment.
, the company's vice president of neurology, believes that the top-line data released today represents only the early analysis available, and that several analyses, including important biomarker data, are expected to take place in the near future.
additional planned analysis of clinical outcome scales and biomarkers will help us develop a long-term development plan for the treatment of AD at troriluzole.
Troriluzole is a pre-drug formulation for the anti-glutamate drug Riluzole, which suppresses synapse levels of glutamate.
glutamate dysfunction is a feature of AD, the pre-drug formula Billy Rutte is easier to take.
twice a day on an empty stomach, while troriluzole only takes once a day, regardless of food.
as a pre-drug, it also reduces the burden on the liver.
past 12 months, troriluzole has been reporting disappointing news.
, Biohaven announced that the drug showed no better results in treating GAD than a placebo.
June, the company published the results of phase 2/3 clinical trials of obsessive compulsive disorder, which did not reach the primary clinical endpoint by week 12, although they had a numerically consistent improvement over placebo.
this, the company plans to push troriluzole for obsessive compulsive disorder treatment into a complete Phase 3 clinical program with a larger sample size and a higher dose group.
source: 1.Biohaven's Prodrug Strikes Out Again, This Time Against Alzheimer's 2.Biohaven Provides Update On Phase 2/3 Trial And Alzheimer's Disease Program