Promising Phase 3 Trial LUCIDITY Interim Data for new Alzheimer’s Drug Released

Research into new pharmacological agents aiming to improve on existing treatments of Alzheimer’s disease with a new drug, hydromethylthionine or HMTM, has shown slower cognitive decline in those receiving treatment compared to controls. The basis for this drug is to reduce the development of neurofibrillary tangles comprised of misfolded tau protein, one of the characteristic changes seen in the brain of patients with Alzheimer’s, as well as associations with other dementias (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3090074/), and the cognitive decline associated with normal ageing (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6596650/). Currently, the monoclonal antibody, aducanumab, is only one disease-modifying treatment for Alzheimer’s disease, and this works by targeting another misfolded protein plaque pathway associated with Alzheimer’s disease, reducing amyloid plaque formation in the brain (https://www.nia.nih.gov/health/how-alzheimers-disease-treated#:~:text=Aducanumab%20is%20the%20only%20disease,brain%20lesions%20associated%20with%20Alzheimer’s.). The hope is that by reducing the formation of the tau neurofibrillary tangles, disease advancement will slow, enhancing the quality of life of those with Alzheimer’s disease, hopefully improving longevity, and providing another avenue to efficacious treatment to patients.
The study recruited 598 patients with memory loss, diagnosed Mild Cognitive Impairment (MCI or MCI-AD), probable/early Alzheimer’s disease, or mild-moderate Alzheimer’s disease, across over 100 centres in the United States, Canada, UK, France, Belgium, Italy, Spain, and Poland. Patients were required to take 2 tablets orally, twice a day, and were randomised into one of three experimental groups that neither the patient nor their doctor were aware of:
• 2 tablets of 4 mg of HMTM twice daily (16 mg per day)
• 1 tablet of 4 mg HMTM and 1 placebo tablet twice daily (8 mg per day)
• 2 placebo tablets twice daily
Throughout the trial, disease progression was assessed using MRI scans to measure neurological changes seen in Alzheimer’s disease, regular medical check-ups to look for off-target health effects, and cognitive assessments comprising of both oral and written tests. Currently the trial has progressed from a year-long blind phase of the trial where patients are unaware of whether they are receiving treatment or control, and they are now undergoing a further year in an open-label phase of the study, where both participants and healthcare providers are aware of the treatment status of the individuals. Interim data released this year shows both cognitive and functional improvements in the treatment group compared to the controls in patients across the different groups representing different degrees of cognitive impairment. Furthermore, the safety profile of HMTM is considered favourable and in-line with previous phases of the trial.
These results are so promising that the trial has been issued an Innovation Passport in May of this year by the Medicines and Healthcare products Regulatory Agency (MHRA), which comprises the first step in the Innovative Licensing and Access Pathway (ILAP), which in turn facilitates quicker product development and delivery with the help of multiple collaborators. This is extremely promising and indicates support from external regulatory bodies for making HMTM available to Alzheimer’s patients currently receiving traditional treatment.

https://www.pmlive.com/pharma_news/taurx_shares_phase_3_trial_data_for_alzheimers_drug_1449477
https://www.luciditytrial.com/
https://www.alzheimer-europe.org/news/taurx-reaches-new-milestone-its-lucidity-phase-iii-trial-ad
https://www.prnewswire.com/in/news-releases/tau-targeting-alzheimer-s-treatment-hmtm-moving-toward-regulatory-submission-based-on-initial-data-from-taurx-s-lucidity-trial-880447354.html
https://www.alzheimer-europe.org/research/clinical-trials/lucidity