2022-10-06| Trials & Approvals

Though Alzheimer’s Treatment Fails Presenting Primary Endpoints, TauRx is Still Seeking Approval

by Max Heirich
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Despite their Alzheimer’s treatment failing to present the primary endpoints in the Phase 3 LUCIDITY study, TauRx intends to push Hydromethylthionine mesylate (HMTM) for approval. However, researchers still gathered valuable data on the potential Alzheimer’s treatment. 

Related Article: Biogen Concludes $900 Million Settlement Before Posting Positive Data From Alzheimer’s Trial

Unable to Certify Primary Endpoints

HMTM treats Alzheimer’s through inhibiting abnormal tau aggregate accumulation, a recognized and important pathological signature in various neurodegenerative disorders. 

TauRx enrolled HMTM in the Phase 3 LUCIDITY study, comparing twice weekly HMTM with the placebo methylthioninium chloride (MTC). Researchers chose MTC, a dye, in order to protect the blindness of the study as a side effect of HMTM is urine discoloration. 

However, issues arose as researchers found that participants administered MTC had blood levels of an active drug above the threshold needed to produce a clinical effect. Without a true placebo, the clinical trial could not determine primary clinical endpoints. In addition, after reviewing new data, TauRx now believes any valid blinded placebo-controlled trials are not “technically feasible.”

TauRx gathered some valuable data from the LUCIDITY study. For one, after the 52-week-long study, researchers saw patients treated with HMTM had a minimal decline along the ADAS-cog11 and ADCS-ADL23 scales. A typical decline is around five units on both scales. However, HMTM-treated patients declined by 1.3 ADAS-cog11 units and -1.0 ADCS-ADL23 units. In addition, HMTM’s safety profile remained “strong and consistent with earlier published HMTM trial data.”

On what data was gathered from the study, TauRx’s newly appointed Chief Medical Officer, Dr. Richard Stefanacci, said, “These data support our ability to pursue regulatory submissions. We look forward to making a significant difference addressing this global unmet need with a medication that is affordable, easy to administer, and safe.”

Following the study, TauRx intends to submit HMTM for regulatory approval in the US and Canada in 2023. The company then asserted that it would make additional submissions in other territories. Though unable to meet the study’s primary endpoints, the data gathered from the study does show effectiveness. However, whether HMTM will win approval remains to be seen. 

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