Phase 2 Clinical Trial of GRF6019 in Alzheimer’s Disease initiated by Alkahest

Alkahest Inc. (“Alkahest”), a clinical-stage biotechnology company focused on developing innovative therapies to treat age-related diseases, announced the initiation of a Phase 2 randomized, double-blinded dose response study of GRF6019 in patients with mild to moderate Alzheimer’s Disease (ALK6019-201).

“The initiation of this study represents a significant milestone for Alkahest, and reflects our commitment to developing innovative therapies to treat this devastating disease,” said Karoly Nikolich, President and Chief Executive Officer of Alkahest. “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. We are excited to advance this lead plasma-derived product into the clinic, and we look forward to working with clinical experts, patients and their families as we continue to pursue this novel approach to the treatment of Alzheimer’s disease.”

“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,” said Sam Jackson, Alkahest’s Chief Medical Officer. “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.”

The ALK6019-201 study is designed to evaluate the safety, tolerability, and feasibility of GRF6019 infusions in patients with mild to moderate Alzheimer’s disease. A total of 40 patients will be enrolled and randomized to receive one of two doses of GRF6019 during the study.

GRF6019 is a plasma-derived product in clinical development for the treatment of neurodegenerative diseases. GRF6019 is a proprietary product manufactured by Grifols, a Barcelona-based global corporation marketing and developing human plasma protein therapeutics. GRF6019 does not require blood type-matching and is optimized for therapeutic uses.  Results from preclinical studies show improvements in motor and cognitive performance, and histological correlates, following various dosing regimens of GRF6019.

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News Source: Alkahest Website

Image Source: https://emedmultispecialtygroup.com/2018/03/20/alzheimers-disease-symptoms-care/