After TauRx Pharmaceutics’ investigational Alzheimer’s treatment hydromethylthionine mesylate (HMTM) was found to slow the disease’s progression it could, if approved, become the first oral treatment targeting the tau protein.

Conventionally, targeted therapies for Alzheimer’s have focused on the amyloid protein rather than tau and TauRx’s treatment is the only tau protein to have completed phase 3 trials.

In research revealed at the recent Alzheimer’s and Parkinson’s Diseases Conference in Vienna, Austria HMTM was shown to slow the progression of Alzheimer’s disease over a period of at least 18 months with potentially clinically meaningful treatment benefits lasting up to two years.

The findings were drawn from a phase 3 trial and placebo data from closely matched subjects available from the Critical Path in AD (CPAD) Institute database, which contains information from nearly 10,000 patients that have taken part in 36 global trials.

The HMTM data demonstrated a slower progression of Alzheimer’s disease according to both the ADAS-cog scoring system and the clinical dementia rating (CDR) scale, which are used internationally to assess the severity and progression of the disease in patients.

Claude Wischik, TauRx chief executive officer and co-founder, said: “Although this is not a cure, the research suggests that starting HMTM treatment early in the disease process can substantially delay progression.

“The combination of a strong safety profile, as evidenced from trials involving more than 3,000 patients, and oral administration leads us to believe we have a drug that people would be able to take in the same way they take other prescription medication.

The Singaporean company has now applied for marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as well as feedback from the National Institute for Health and Care Excellence (NICE) on the suitability for the drug for use within the NHS.

If all goes to plan for TauRx it will be positioned to enter a market that is forecast to be worth $19.3bn across eight major markets, driven by an ageing global population and the entry of expensive disease-modifying therapies (DMTs).

Eisai/Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) were the first DMTs to be approved and are forecast to lead the pack, but analysts at GlobalData said earlier this year they expected TauRx’s HMTM – as well as Novo Nordisk’s NN6535 (semaglutide) – to stand out as late-stage candidates, thanks to their novel modes of action, convenient oral administration and improved safety profiles.