Alkahest Announces Peer-Reviewed Publication Demonstrating Safety and Tolerability of GRF6019 in Patients with Mild-to-Moderate Alzheimer’s Disease

January 28, 2021, SAN CARLOS, Calif. – Alkahest, Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases and a subsidiary of Grifols, today announced the publication of a peer-reviewed article in the journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions. The publication titled, “Safety and tolerability of GRF6019 in mild-to-moderate Alzheimer’s disease dementia,” describes Alkahest’s Phase 2 clinical trial investigating GRF6019 as a potential treatment for patients with Alzheimer’s disease (AD) and is available online here.

 “With a rapidly growing elderly population, the rates of chronic age-related diseases are on track to skyrocket in the coming years,” said Karoly Nikolich, chief executive officer and co-founder of Alkahest.  “The publication of GRF6019’s safety and tolerability data in Alzheimer’s and Dementia reflects the potential of Alkahest’s novel approach to tackle Alzheimer’s disease, an indication that has seen little meaningful clinical progress in the past few decades. We look forward to further studying its potential as a more effective therapeutic option for this drastically underserved patient population.”

Study highlights:

• The trial met its primary endpoint, demonstrating that both dose levels were safe and well tolerated, with no clear difference in adverse events between the 100 and the 250 milliliter dose arms.
• Patients treated with GRF6019 showed a lack of cognitive decline and limited functional decline over the 24-week study period.

Alkahest is studying GRF6019 as a potential treatment for age-related diseases in collaboration with clinical development partner and parent company, Grifols. GRF6019 is a proprietary plasma fraction that has enhanced neurogenesis, improved age-related deficits in learning and memory and reduced neuroinflammation in preclinical animal models. Having completed human studies with GRF6019 in patients with both mild-to-moderate and severe Alzheimer’s disease, Alkahest plans to advance GRF6019 to further study its efficacy in these patient populations.

About ALK6019-201

The Phase 2a ALK6019-201 trial was designed to evaluate the safety, tolerability, and potential therapeutic effects of two doses of GRF6019 in patients with mild-to-moderate Alzheimer’s disease over six months. Subjects were randomized to receive either 100 mL or 250 mL of GRF6019 given by intravenous administration daily for five consecutive days during week 1 and again for five consecutive days during week 13, with a treatment-free interval of 11 weeks following each dose.