The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
PharmaKure has filed a Clinical Trial Application (CTA) with the UK’s Medicines and Healthcare Regulatory Agency (MHRA) to evaluate PK051, a combination drug targeting disaggregates of amyloid-β proteins.
The CTA is for a Phase IIa trial of PK051 in patients with mild cognitive impairment. The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted.
According to the company’s website, its lead candidate PK051 combines an antidepressant and antipsychotic. Its mechanism of action is through “dis-aggregation of previously formed toxic oligomers of amyloid proteins and prevention of the released monomers acting as seeds to catalyse formation of new oligomers”. Vitally, the treatment has potential “to become a prophylactic and/or first line of a cost-effective treatment against early Alzheimer’s”.
The Chief Executive Officer of PharmaKure, Dr Farid Khan, stated that the company believes that its combination drug PK051 “has the potential to bring quality of life to patients”.
CTA submission – progressing development of the amyloid-targeting drug PK051
“The MHRA trial is a strong next step in the development of PK051. Upon MHRA approval, the company plans to initiate a Phase IIa clinical trial to evaluate the multi ascending dose, safety and tolerability of PK051,” stated Dr Bob Smith, Clinical Director at PharmaKure. “The clinical 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.”
According to PharmaKure, there are 850,000 people in the UK, and 44 million people worldwide currently experiencing Alzheimer’s disease or dementia related illnesses. Overproduction and/or deposition of amyloid-β is now thought to be the initial event in Alzheimer’s pathology.
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.