Alkahest Announces Positive Top-line Data From Phase 2 Study In Mild To Moderate Alzheimer's Disease

San Carlos, CA (GLOBE NEWSWIRE) - Alkahest, Inc., a clinical-stage biotechnology company focused on developing transformative therapies to treat age-related diseases, today announced top-line data from its phase 2 clinical trial of its candidate GRF6019 in mild-to-moderate Alzheimer’s disease dementia (AD). The study was designed to evaluate the safety, tolerability, and potential therapeutic effects of multiple doses of GRF6019 in patients with mild-to-moderate AD over six months. Subjects were randomized and treated intravenously with 100mL or 250mL of GRF6019 for five consecutive days during Week 1 and again for five consecutive days during Week 13, with a treatment-free interval of 12 weeks following each dose. Dosing with GRF6019 was safe and well-tolerated in subjects with AD.

Secondary endpoints showed that subjects receiving GRF6019 had no decline in cognition, as measured by the 11-item AD Assessment Scale-cognitive subscale (ADAS-Cog11) and the Mini-Mental State Examination (MMSE), and negligible decline in function by the AD Cooperative Study Activities of Daily Living scale 23-item version (ADCS-ADL23), and the Clinical Dementia Rating scale Sum-of-Boxes (CDR-SB) score. These data demonstrated a maintenance of cognitive and functional status over a period of 6 months in patients who would be expected to decline in this timeframe.

“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. “Developing impactful treatments for this disease and other neurodegenerative diseases of aging has proven unsuccessful for decades. GRF6019 represents an innovative approach to effectively treating Alzheimer’s disease by targeting multiple underlying mechanisms of disease, and these data support the continued development of GRF6019 and other plasma protein fractions in Alzheimer’s disease.”

About GRF6019 and GRF6021
Alkahest, and clinical development partner Grifols, are studying GRF6019 and GRF6021 for the treatment of age-related diseases.  GRF6019 and GRF6021, proprietary plasma fractions, are developed and provided by Grifols.  In animal models, these plasma fractions enhance neurogenesis, improve age-related deficits in learning and memory, and reduce neuroinflammation.   Phase 2 clinical trials with GRF6019 and GRF6021 are ongoing in Alzheimer’s disease and Parkinson’s disease, respectively, with other age-related indications being explored.

About Alkahest
Alkahest is a clinical stage biopharmaceutical company developing treatments for neurodegenerative and age-related diseases with transformative therapies targeting the aging plasma proteome. The Alkahest pipeline includes multiple therapeutic candidates ranging from selected plasma fractions to protein-targeted interventions which aim to slow the detrimental biological processes of aging. Alkahest is developing novel plasma-based therapies in collaboration with Grifols, a global healthcare company and leading producer of plasma therapies. For further information, see www.alkahest.com or follow us on Twitter @AlkahestInc.

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