PharmaKure gains authorisation for next stage testing on Alzheimer's treatment

Clinical stage pharmaceutical company PharmaKure gains permission from UK authorities to enter into further testing for PK051 for the treatment of patients with mild cognitive impairment associated with Alzheimer's disease. 

Now, PharmaKure, a UK-based company that focuses on developing precision medicines for Alzheimer’s and other neurodegenerative diseases, has received permission to enter Phase II testing of their therapy PK051. 

The UK Medicines and Healthcare Regulatory Agency (MHRA) granted Clinical Trial Authorisation to PharmaKure to progress with testing PK051, in an oral combined form, as a treatment for patients with mild cognitive impairment. PharmaKure plans to start a muti-ascending dose Phase IIa clinical trial to assess the safety and tolerability of the drug in respect to its intended use. 

The excessive production of amyloid-β proteins and build up of amyloid plaques in the brain are associated with the disease pathology of many neurodegenerative disorders, including Alzheimer's disease, in their early stages. In light of this, much research has been dedicated to the discovery and development of drugs that prevent or reduce the build up of plaques. PK051 works by targeting the disaggregation of amyloid-β proteins, and breaking down plaques, hopefully reducing the disease severity and progression of early-stage Alzheimer’s disease. 

"The MHRA authorisation marks a major step forward in our mission to develop PK051 as a disease modifying therapy for MCI due to Alzheimer’s Disease,” stated Dr Farid Khan, CEO of PharmaKure. “This authorisation follows successful study results recently announced by the Company 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.”

Dr Bob Smith, Chief Clinical Director, PharmaKure, commented: “We are delighted to have approval to begin clinical testing of PK051. This Phase 2a study is intended to confirm safety, tolerability and to help us determine an appropriate dose for future efficacy studies. The trial will involve 40 patients with MCI due to Alzheimer’s Disease at a single site in the UK. The first patient is expected to be dosed in early to mid 2024, with preliminary clinical data emerging within 12 months of first dose.”

Source: 

PharmaKure. Press Release 04/01/2024. https://pharmakure.com/category/press-releases/