PharmaKure Ltd.

The company developing precision medicines for Alzheimer’s and other neurodegenerative diseases has announced that the company has filed a Clinical Trial Application (CTA) with the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom to evaluate PK051. PK051 is a combined drug that targets disaggregates 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 CTA submission includes comprehensive data from pre-clinical studies, rigorous safety assessments, and the robust clinical trial protocol that will be followed during the trial. PharmaKure is committed to the highest standards of scientific and ethical conduct throughout the clinical trial process. “We are dedicated to advancing the science of Alzheimer’s Disease, and we believe that PK051 has the potential to bring quality of life to patients,” said Farid Khan, CEO of PharmaKure. “Our team has worked tirelessly to reach this milestone, and we are eager to collaborate with the MHRA and other stakeholders to bring PK051 one step closer to those in need.” Bob Smith, clinical director at PharmaKure: “The MHRA trial is a strong next step in the development of PK051. Upon MHRA approval, the company plans to initiate a phase 2a clinical trial to evaluate the multi ascending dose, safety and tolerability of PK051. “The trial will involve 40 patients at a single site located in Motherwell, UK. The first patient is expected to be dosed in early 2024, with clinical data emerging within 12 months of first dose.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); This CTA submission follows successful study results recently announced by PharmaKure for a 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.

APIS Assay Technologies and PharmaKure will jointly develop Clickmers, the single-stranded DNA oligonucleotides modified using Click chemistry, for the detection of biomarkers associated with Alzheimer's disease (AD) PharmaKure and APIS enter collaboration. (Credit: The University of Manchester) UK-based speciality biopharmaceutical company PharmaKure has teamed with APIS Assay Technologies to develop Clickmers related to neurodegenerative diseases. APIS Assay Technologies is a diagnostic company with scientific expertise in biomarker translation, molecular diagnostics and bioinformatics. PharmaKure, a spin-out from the University of Manchester, is specialised in companion diagnostics for the treatment of neurological diseases. Under the collaboration, APIS and PharmaKure will jointly develop Clickmers, used for highly selective detection of biomarkers associated with Alzheimer’s disease (AD). Clickmers are single-stranded DNA oligonucleotides, modified using Click chemistry, a class of simple, atom-economy reactions commonly used for joining two molecular entities of choice. APIS technology head Helen Fielder said: “It is a fantastic opportunity to support the development of novel diagnostic tests that detect biomarkers associated with neurodegenerative diseases, such as Alzheimer’s. “Using APIS’ novel Clickmer technology, we aim to deliver highly specific and high-affinity detection of Alzheimer’s biomarkers, to support earlier detection of the disease. “Earlier detection alongside PharmaKure’s lead drug candidate PK051 has the potential to significantly improve the treatment of AD patients.” The two companies will advance the development and clinical validation of specific Clickmers that target biomarkers associated with Alzheimer’s disease pathology. Certain blood biomarkers of amyloid-b, aggregated α-synuclein, aggregated Tau, NFL and DJ-1 have been associated with Alzheimer’s Disease pathology. The Clickmer technology facilitates the sensitive and accurate measurement of the levels of these biomarkers in blood. Alzheimer’s disease is a deadly disease that causes a progressive decline in memory and other aspects of cognition, including the most common form of dementia. PharmaKure said that it aims to precisely identify patients in the early stages of Alzheimer’s Disease, even before they have any symptoms. PharmaKure CEO Farid Khan said: “We are excited to collaborate with APIS on the possibility of using Clickmers for advancing increased binding affinity towards Alzheimer’s biomarkers such as amyloid-b. “This is one of the steps to bring to the market effective disease-modifying therapeutics in AD by combining our lead drug candidate PK051 with an early detection of disease-related biomarker assays.”