On 5 August, Alkahest, a clinical stage biopharmaceutical company developing treatments for neurodegenerative and age-related diseases with transformative therapies, announced top-line data from its Phase II clinical trial assessing the safety and tolerability of GRF6019 infusions in people with mild-to-moderate Alzheimer’s disease (AD). 40 US participants were randomised to receive 100ml or 250ml of GRF6019, a plasma-derived product, by intravenous infusion for five consecutive days during week 1 and then for five consecutive days during week 13.
The primary outcome measure included the incidence of treatment-emergent adverse effects. The company reported that the experimental drug was safe and well-tolerated in participants with mild-to-moderate AD. Secondary outcome measures included six-month change on some widely used cognitive and clinical batteries. Data showed that participants receiving GRF6019 maintained cognitive and functional status throughout the six-month period. Alkahest is conducting another Phase II clinical trial with GRF6019 in people with severe AD. The company announced the dosing of the first participant in March 2019 and plans to enrol and randomise 20 US participants.
“These top-line results indicate a potential benefit of this plasma protein fraction in slowing the progression of cognitive decline in patients with mild to moderate Alzheimer’s disease,” said Dr Karoly Nikolich, chief executive officer of Alkahest.
