Current medications for Alzheimer’s Disease are approved specifically for dementia-stage AD. In recent years, there has been a growing movement to develop drugs to target pre-dementia AD.
Identifying people who are at risk and treating them before they decline to dementia is important and will have a greater impact on quality of life for these people.
For treating Prodromal AD, the bar for safety is extremely high. MMFS has an excellent safety profile and is ideally suited for prevention.
In targeting Prodromal AD, we have focused on elderly who have a high risk for developing dementia – those with mild cognitive impairment, mild behavioral impairment, and sleep disorder.
Our active clinical trialis a Phase 2 trial, testing multiple doses of MMFS-205 (L-TAMS) for efficacy in cognition, mood, and sleep.
Early Alzheimer's Disease (Stage 3 & 4 AD)
Currently, most clinical trials for AD have failed. There has not been a new FDA-approved drug since 2003. One hypothesis as to why it is difficult to develop a drug for AD is that once the brain has degenerated, it cannot be treated. However, in preclinical animal models of AD, we found that MMFS is effective even at end-stage AD.
In human, two completed clinical trials show that MMFS (L-TAMS) administration effectively improves cognition in stage 3 and stage 4 AD.
Our active clinical trial is to confirm the positive results from our previous two trials, and its design satisfies regulatory requirements for an AD drug.
According to the Centers for Disease Control and Prevention, 11% of children in the US have ADHD. 60% of those maintain symptoms into adulthood.
The current treatment for Adult ADHD is focused on improving attention and reducing hyperactivity, but does not address cognitive impairment and executive dysfunction that frequently occurs in adult ADHD patients. MMFS has been show to improve cognition and executive function.
Our clinical trial was conducted at Harvard/MGH. Results were positive and future Adult ADHD clinical trials are being planned.
*L-TAMS is API of MMFS series of products under development