Alkahest has commenced a Phase ll trial of GRF6019 to treat patients with mild to moderate Alzheimer’s disease.
The randomised double-blinded response study has also dosed its first patient with GRF6019, a plasma-derived product currently under investigation for the treatment of neurodegenerative diseases.
Safety, tolerability, and feasibility of GRF6019 infusions in patients with mild to moderate Alzheimer’s disease will be analysed during the new ALK6019-201 trial.
The trial expects to enrol 40 patients, who will be randomised to receive one of two GRF6019 doses.
Alkahest president and CEO Karoly Nikolich said: “Based on the promising data from our PLasma for Alzheimer SymptoM Amelioration (PLASMA) study last year, we have progressed the development of GRF6019, a proprietary plasma fraction developed and provided by Grifols, our development and clinical partner.”
GRF6019 has been manufactured by Spain-based human plasma protein therapeutics solution provider Grifols.
In various preclinical studies, the product has reportedly demonstrated its ability to improve patient’s motor and cognitive performance, as well as histological correlates.
Alkahest chief medical officer Sam Jackson said: “As the population ages, the number of people with Alzheimer’s disease and other neurodegenerative diseases will increase sharply, precipitating an urgent need for innovative therapies.
“GRF6019 has demonstrated encouraging preclinical results, including improvements in cognitive and histological measures compared to previously evaluated whole plasma, and has the potential to address this growing unmet need for an effective treatment for Alzheimer’s disease.”
Alkahest is primarily involved in developing treatments for age-related diseases, with an emphasis on neurodegeneration.