PharmaKure submits MHRA CTA for Phase 2a Clinical Trial of PK051 in patients with mild cognitive impairment
Manchester, United Kingdom, 24 October 2023 – 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 ALZmetrixTM 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.
Editors’ notes
About Alzheimer’s Disease - Alzheimer’s disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer’s is the most common form of dementia, accounting for 60 to 80 percent of all cases. Every three seconds someone in the world develops dementia. 850,000 people (UK) and 44 million people (worldwide) are currently suffering from Alzheimer’s or dementia related illnesses. In 2020, the total cost of care for people in the UK was £34.7 billion. Globally, the cost was $360 billion and by 2050 it could reach $1 trillion (source Alzheimer’s Research UK), unless we find a way to slow the disease.
About PharmaKure - PharmaKure is a clinical stage pharmaceutical company, spun out from the University of Manchester. The company is actively researching, developing, commercialising and repositioning repurposed drugs for the treatment of Alzheimer’s, Parkinson’s and other neurodegenerative diseases, as well as developing its companion ALZmetrixTM diagnostic.
For more information, contact info@pharmakure.com or see PharmaKure’s website www.pharmakure.com
Company Contacts
CEO: Dr Farid Khan - farid.khan@pharmakure.com
Clinical Director – Dr Bob Smith - robert.smith@pharmakure.com
CCO: Dr Naz Bashir - naz.bashir@pharmakure.com
