Home Medizin PharmaKure hat die MHRA Clinical Trial Authorization (CTA) für PK051 zur Behandlung leichter kognitiver Beeinträchtigungen aufgrund der Alzheimer-Krankheit erhalten

PharmaKure hat die MHRA Clinical Trial Authorization (CTA) für PK051 zur Behandlung leichter kognitiver Beeinträchtigungen aufgrund der Alzheimer-Krankheit erhalten

von NFI Redaktion

PharmaKure, a clinical-stage pharmaceutical company developing precision medicines for Alzheimer’s disease and other neurodegenerative disorders, has announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the company to conduct a phase 2a dose-escalation study to evaluate the safety and tolerability of PK051 for the treatment of mild cognitive impairment (MCI).

PK051 is an oral combination therapy targeting the desegregation of amyloid-β proteins. There is growing scientific acceptance that overproduction and/or deposition of amyloid-β is the initial event in the pathology of Alzheimer’s disease.

„The MHRA approval represents a major step forward in our mission to develop PK051 as a disease-modifying therapy for MCI due to Alzheimer’s disease.“

Dr. Farid Khan, CEO, PharmaKure.

„This approval follows successful study results recently announced by the company for a novel whole-blood test for quantifying biomarkers for Alzheimer’s disease. PharmaKure’s proprietary ALZmetrixTM A blood test can identify blood-based biomarkers in patients with Alzheimer’s disease to provide early warning of cognitive decline. As a companion diagnostic, this could lead to earlier offerings of treatments such as PK051 and achieve better population health outcomes.“

Dr. Farid Khan, CEO, PharmaKure.

„We are excited to receive approval to initiate clinical trials of PK051. This phase 2a study is intended to confirm safety and tolerability and help us determine an appropriate dose for future efficacy studies. The study will involve 40 patients with MCI due to Alzheimer’s disease at a single site in the United Kingdom. The first patient is expected to receive the dose by early to mid-2024, with preliminary clinical data expected within 12 months of the first dose.“

Dr. Bob Smith, Chief Clinical Director, PharmaKure

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