PharmaKure announces that the UK Medicines and Healthcare Regulatory Agency (MHRA) has granted Clinical Trial Authorisation (CTA) for PharmaKure to commence a muti-ascending dose Phase IIa study to evaluate safety and tolerability of PK051 intended for the treatment of mild cognitive impairment (MCI).
PK051 is an oral combined drug that targets disaggregation 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 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,” said Dr Farid Khan, CEO, 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 ALZmetrix 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 IIa 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 related 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.”