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TauRx shares phase 3 trial data for Alzheimer's drug

Those receiving the drug experienced a significantly slower decline than usual

Alzheimer's disease

A specialist in tau-based research into Alzheimer’s disease, TauRx Pharmaceuticals has shared initial data from LUCIDITY, a phase 3 clinical trial.

TauRx is focused on working with Alzheimer’s patients and their caregivers, in tandem with healthcare professionals, in order to provide safe and effective treatments. It is estimated that around 50 million people worldwide live with Alzheimer’s, a condition that also impacts families and primary care providers.

The trial assessed TauRx’s lead investigative oral drug, HMTM, which has been tested in 598 people diagnosed with Alzheimer’s. Initial data taken from the LUCIDITY trial suggests that those receiving HMTM experienced a decline at a rate significantly less than is usual in Alzheimer’s, based on published research.

Those involved in the trial have moved forward to an additional one year open label phase, following the 12-month blind phase of the study.

Professor Claude Wischik, executive chairman and co-founder of TauRx, said: “The output indicates that participants receiving HMTM decline at a rate substantially less than is typical in Alzheimer’s based on published research. This was seen for both cognitive and functional endpoints across a broad range of severity from mild cognitive impairment (MCI) to moderate Alzheimer’s. Importantly, the safety profile is favourable and consistent with previous studies.

He added: “Today with limited treatments for Alzheimer’s, the standard of care does not impact the underlying causes of symptom progression. HMTM aims to significantly slow disease progression, providing longer term benefits compared to medications brought to market almost twenty years ago.”

On 18 May 2022, prior to the LUCIDITY interim data being released, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the company an Innovation Passport, which is the first stage of the Innovative Licensing and Access Pathway (ILAP). It is intended to speed up development and approval times, thus allowing better access to new products and indications.

Professor Wischik concluded: “The ILAP designation represents a clear signal of regulatory support for a prospective treatment breakthrough in Alzheimer’s, which remains one of the world’s greatest unmet medical needs.

“Dementia is a leading cause of death around the world, and the Innovation Passport, as the first stage of the ILAP scheme, enables access to the collaborative approach of regulators and associated health technology assessment bodies to both drug licencing and access throughout the UK.”

Article by
Fleur Jeffries

1st June 2022

From: Research, Healthcare



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