MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.
Clinical-stage UK-based pharmaceutical company, PharmaKure, has been granted Clinical Trial Authorization (CTA) from the United Kingdom’s regulatory body, the Medicines and Healthcare Regulatory Agency, to start a Phase IIa study to assess an oral combined drug for the treatment of mild cognitive impairment (MCI) as a result of Alzheimer’s Disease.
According to a Jan. 4, 2024 press release, the CTA has been granted for PharmaKure’s PK051 oral combined drug that has been designed to target disaggregation of amyloid-β proteins—overproduction of which is being increasingly accepted as the initial event in Alzheimer’s Disease pathology. In the multi-ascending dose Phase IIa study, the company will evaluate the safety and tolerability of PK051 in patients.
“The MHRA authorization 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, in the press release. “This authorization 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.”
“We are delighted to have approval to begin clinical testing of PK051,” added Dr. Bob Smith, chief clinical director, PharmaKure, in the press release. “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 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.”