Singapore (Commonwealth Union)_ Singapore’s TauRx Pharmaceuticals, which claims to be the world leader in tau-based research for Alzheimer’s disease, has revealed encouraging results for their primary oral investigational medication, hydromethylthionine mesylate (HMTM). The medicine was proven to be beneficial in enhancing cognition in early Alzheimer’s disease patients (AD). TauRx currently aims to submit HMTM for regulatory clearance in the United States and Canada in 2023, with additional countries to follow, based on its overall intentions to market HMTM and conduct clinical studies for other neurodegenerative illnesses.
According to Pippa Salter, senior neurology analyst at pharma analytic firm GlobalData, a major unmet need in the AD industry is the discovery of disease-modifying treatments (DMTs) that can stop or even reverse the illness. The amyloid hypothesis has historically dominated the Alzheimer’s disease (AD) field; however, due to the many failures of amyloid-targeting treatment candidates, the focus has shifted to include anti-tau medicines. She highlighted that if approved, TauRx’s HMTM has the capacity to become the first DMT targeting tau to be authorized for AD, with GlobalData predicting that global (8MM: USA, France, Germany, Italy, Spain, UK, Japan, and China) sales for HMTM will hit $127 million by 2030.
If authorized, HMTM would have a significant advantage over the other DMT on the market, Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (MAb) Aduhelm (aducanumab), because it is not linked with amyloid-related imaging abnormalities (ARIAs). Additionally, as an oral medication, HMTM is more comfortable for patients than the intravenous infusions necessary for the majority of anti-Aβ MAbs.
Aduhelm’s debut has been extremely disappointing since the US Food and Drug Administration (FDA) granted its contentious fast clearance in June of last year. Ms Salter said: “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.”
