GlobalData : TauRx’s HMTM could become first oral DMT targeting Tau for Alzheimer’s disease, says GlobalData

Following the Phase III LUCIDITY trial (NCT03446001) results announced by TauRx at the AD/PD 2024 International Conference on Alzheimer's and Parkinson's Diseases, for hydromethylthionine mesylate (HMTM);

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

"At AD/PD 2024, TauRx announced that it has initiated regulatory discussions with both the UK MHRA and the US FDA, meaning that HMTM has the potential to become the first disease-modifying therapy (DMT) approved for AD to target tau, as well as the first orally available DMT. As an oral therapeutic, HMTM could easily be incorporated into current standard clinical care pathways making it an attractive treatment option.

"A key theme at the AD/PD 2024 conference is the concept of the meaningful benefits of treatment for patients and caregivers. Relating to this, in the mild cognitive impairment (MCI) subpopulation, HMTM treatment resulted in a 48% reduction in progression from MCI to AD compared to the control arm at 12 months. Delaying disease progression is ultimately what patient and caregivers want, so this is a very important outcome for the potential success of HMTM.

"Key opinion leaders (KOLs) previously interviewed by GlobalData agreed that wider availability and access to DMTs for AD was the most important unmet need in the space. The risk of amyloid-related imaging abnormalities (ARIA) seen in the anti-amyloid beta monoclonal antibody drug class was highlighted as an important barrier to meeting the need for DMTs in patients who are at higher risk of ARIA or are ApoE4 carriers. HMTM is unlikely to face this type of barrier in terms of patient exclusion due to safety concerns, given its benign safety profile, with 95% of trial participants choosing to continue for the 12-month extension period, showing a high willingness to continue taking the drug.

"Despite showing some promise, it remains to be seen if regulators will require further data for the approval of HMTM given the lack of a placebo comparator and the lack of meaningful primary endpoint data at both 12-months and 24-months. GlobalData's Drugs Database shows that currently there are only three other oral tau specific-targeting drugs in clinical development for AD: reMYND's ReS-19T, Lilly's ACI-3024, and Oligomerix's OLX-07010, which could be potential competitors for HMTM; however, they are still in the earlier (Phase I and II) stages of development."