PharmaKure receives UK MHRA nod to begin phase 2a study of PK051 to treat mild cognitive impairment due to Alzheimers disease

PharmaKure, a clinical stage pharmaceutical company developing precision medicines for Alzheimer’s disease and other neurodegenerative diseases, 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 2a 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-ß proteins. There is increasing scientific acceptance that overproduction and/or deposition of amyloid-ß 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 2a 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.”

Alzheimer’s disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer’s is the most common form of dementia, accounting for 60 to 80 percent of all cases. Every three seconds someone in the world develops dementia. 850,000 people (UK) and 44 million people (worldwide) are currently suffering from Alzheimer’s or dementia related illnesses. In 2020, the total cost of care for people in the UK was £34.7 billion. Globally, the cost was $360 billion and by 2050 it could reach $1 trillion (source Alzheimer’s Research UK), unless we find a way to slow the disease.

PharmaKure is a clinical stage pharmaceutical company, spun out from the University of Manchester. The company is actively researching, developing, commercialising and repositioning repurposed drugs for the treatment of Alzheimer’s, Parkinson’s and other neurodegenerative diseases, as well as developing its companion ALZmetrix diagnostic.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!