Alkahest Announces Initiation of Phase 2 Clinical Trial of GRF6019 in Alzheimer’s Disease

First patient dosed with plasma-derived product GRF6019

SAN CARLOS, Calif.,  — Alkahest Inc. (“Alkahest”), a clinical-stage biotechnology company focused on developing innovative therapies to treat age-related diseases, today 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.

About GRF6019

GRF6019 is a plasma-derived product in clinical development for the treatment of neurodegenerative diseases. Research indicates that proteins in the circulatory system directly affect motor and cognitive function. Alkahest is developing a pipeline of novel products based on this growing body of evidence supporting the beneficial effects of factors present in healthy plasma.  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.

About Alkahest

Alkahest is a privately-held clinical-stage company based in the San Francisco Bay Area developing treatments for age-related diseases, with an emphasis on neurodegeneration — a key medical challenge for our generation. The company’s breakthrough research has elucidated changes in the plasma proteome in healthy aging and age-related diseases, and demonstrated that factors in the blood plasma can be augmented or inhibited in order to reverse detrimental effects of aging in both normal aging and disease models in animals. Alkahest is developing novel plasma-based therapies in collaboration with Barcelona, Spain-based Grifols, a global healthcare company and leading producer of plasma therapies.

Contact Information
Joe McCracken
Vice President Business Development
Alkahest, Inc.

Matthew Shinseki
Stern Investor Relations, Inc.