On 31 May, the company TauRx Therapeutics Ltd announced initial data from its Lucidity Phase III trial for the treatment of Alzheimer’s disease (AD). The Lucidity trial is a randomised, double-blind and placebo-controlled study evaluating the safety and efficacy of hydromethylthionine mesylate in people with AD encompassing mild cognitive impairment due to AD. Hydromethylthionine mesylate (which TauRx refer to under the chemical abbreviation, HMTM) acts by blocking abnormal accumulation of Tau protein in the brain. The study enrolled 598 people with AD who were randomly assigned to one of two doses of HMTM (8 or 16 mg/day), or a placebo, twice daily for one year. Participants have now move forward to an additional one-year open label phase. Initial data suggested that those receiving the experimental tau-targeting drug experienced a decline in cognitive and functional measures than would be expected based on published research.
The data analysis is ongoing and will be reported at a later date. In addition, the safety profile was favourable and consistent with prior studies of the experimental therapy. The company is planning to present an update at the 35th Global Conference of Alzheimer's Disease International (ADI) in June 2022. TauRx will now pursue regulatory submission and coverage for HMTM. On 18 May, prior to the LUCIDITY initial data being released, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted the company an Innovation Passport, which is the first stage of the Innovative Licensing and Access Pathway (ILAP). It is intended to speed up development and approval times. https://taurx.com/news-insights/initial-data-of-lucidity-study