Alkahest has dosed the first patient in a Phase II clinical trial of GRF6019 in collaboration with clinical and development partner Grifols to treat Alzheimer's disease.
The company is also conducting a Phase II study of GRF6019 in mild to moderate Alzheimer's disease and a second selected fraction, GRF6021, in Parkinson's with cognitive impairment.
Alkahest dosed the first subject in the Phase II trial of GRF6021 in December last year. Data from the study is expected this year.
Alkahest chairman and CEO Karoly Nikolich said: “In recent years, it has become evident that there is a complex, multifactorial pathology underlying Alzheimer's disease that available drugs and those currently in development fail to fully address.
“Using our deep understanding of the plasma proteome, we have identified specific proteomic factors as the basis for this potential treatment for Alzheimer's disease.”
As part of the Phase II trial, the safety, tolerability and potential functional benefit of GRF6019 infusions will be evaluated in patients with severe Alzheimer's disease.
Approximately 20 subjects will be enrolled and randomised for the trial and will receive GRF6019 or placebo for five consecutive days.
After that, they will be monitored over the course of nine weeks.
The primary outcome of the trial will examine the safety and tolerability with secondary endpoints measuring changes in cognition, function, and behaviour in these patients.
Nikolich further added: “Patients at more advanced stages of Alzheimer's disease are rarely included in clinical trials, and this novel approach could provide a novel treatment option for these individuals.”
Alkahest and Grifols are studying GRF6019 and GRF6021 for the treatment of age-related diseases.
The proprietary plasma fractions are developed and provided by Grifols.