PharmaKure, a clinical stage pharmaceutical company developing precision medicines for Alzheimer’s Disease and other neurodegenerative diseases, announces that the company has filed a Clinical Trial Application (CTA) with the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom to evaluate PK051.

PK051 is a combined drug that targets disaggregates of amyloid-β proteins. There is increasing scientific acceptance that overproduction and/or deposition of amyloid-β is the initial event in Alzheimer’s Disease pathology. 

The CTA submission includes comprehensive data from pre-clinical studies, rigorous safety assessments, and the robust clinical trial protocol that will be followed during the trial. PharmaKure is committed to the highest standards of scientific and ethical conduct throughout the clinical trial process.

"We are dedicated to advancing the science of Alzheimer’s Disease, and we believe that PK051 has the potential to bring quality of life to patients,” said Dr Farid Khan, CEO of PharmaKure. "Our team has worked tirelessly to reach this milestone, and we are eager to collaborate with the MHRA and other stakeholders to bring PK051 one step closer to those in need."

“The MHRA trial is a strong next step in the development of PK051. Upon MHRA approval, the company plans to initiate a phase 2a clinical trial to evaluate the multi ascending dose, safety and tolerability of PK051,” said Dr Bob Smith, Clinical Director at PharmaKure. “The trial will involve 40 patients at a single site located in Motherwell, UK. The first patient is expected to be dosed in early 2024, with clinical data emerging within 12 months of first dose.”

This CTA submission follows successful study results recently announced by PharmaKure for a novel whole blood test to quantify Alzheimer’s Disease biomarkers. PharmaKure’s proprietary ALZmetrix^TM blood test can identify blood-based biomarkers in patients with Alzheimer’s Disease to provide early warning of cognitive decline. Used as a companion diagnostic, this could enable treatments such as PK051 to be offered earlier to provide better population-based health outcomes.