Following the news that TauRx Therapeutics’ oral anti-tau product, hydromethylthionine mesylate (HMTM), was found to be effective in improving cognition in patients with early Alzheimer’s disease (AD);

Pippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“A key unmet need in the AD market is for the development of disease-modifying therapies (DMTs) that can stop or even reverse the disease. Historically, the amyloid hypothesis has dominated the AD space, however, with multiple failures of amyloid-targeting drug candidates, the focus has widened to include anti-tau therapies.

“Following the trial results, TauRx’s HMTM has the potential to become the first DMT targeting tau to be approved for AD with GlobalData forecasting that global (8MM*) sales for HMTM will reach $127 million by 2030 if it’s approved.

“If approved, HMTM would have a key advantage over the other DMT on the market, Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Aduhelm (aducanumab), as it is not associated with the development of amyloid-related imaging abnormalities (ARIAs). Further, as an oral product, HMTM is more convenient for patients compared with the intravenous infusions required for most of the anti-Aβ mAbs.

“Despite the drug’s potential, there are still some concerns remaining. Due to HMTM’s properties, causing urinary discoloration, it is challenging to run a placebo controlled clinical trial in which the participants remain blind to their treatment arm. Although TauRx tried to mitigate this issue, it has been unsuccessful; as such the trial results are not placebo controlled, instead they have been compared with historical matched individuals with AD from the Alzheimer’s Neuroimaging Initiative. Additionally, previous Phase III trials of HMTM failed to meet their primary endpoints or showed mixed data, leading to a range of opinions of the drug from key opinion leaders previously interviewed by GlobalData.”

*8MM = US, France, Germany, Italy, Spain, UK, Japan, and China