The clinical stage pharma firm PharmaKure has been given the green light for a potentially pivotal trail of an emerging treatment for mild cognitive impairment in Alzheimer’s disease.
Regulatory body, the MHRA, has granted clinical trial authorisation for a Phase 2a study to evaluate safety and tolerability of PK051.
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 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.”
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.
