Alkahest reveals positive outcomes from Phase 2 study of GRF6019

By Mateen Dalal

The study cites that dosing with GRF6019 were harmless and well-tolerated in patients with Alzheimer’s disease dementia (AD).

Alkahest, Inc., a clinical-stage biopharmaceutical company focused on researching and creating transformative therapies to cure age-related diseases, recently shared top-line data from its Phase 2 clinical trial of GRF6019 in mild to moderate Alzheimer’s disease dementia (AD).

According to sources, the study was developed to evaluate the tolerability, safety and potential therapeutic effects of multiple doses of GRF6019 in patients with mild to moderate AD over six months. Subjects for this study were randomly selected and treated intravenously with a dose of 100mL or 250mL of GRF6019 for five days for first week and once more for five continuous days during Week 13, with an interval of 12 weeks following each dose.

Sources cite that patients receiving GRF6019 in the secondary endpoint showed no deterioration in cognition, as measured by the Mini-Mental State Examination (MMSE) and the 11-item ADAS-Cog11 (AD Assessment Scale-cognitive subscale), and slight decline in function by the Clinical Dementia Rating scale Sum-of-Boxes (CDR-SB) score and the AD Cooperative Study Activities of Daily Living scale 23-item version (ADCS-ADL23).

Speaking on the move, Dr. Karoly Nikolich, Chief Executive Officer, Alkahest, said that these results show potential benefit of this plasma protein fraction in reducing the progression of cognitive decline in patients with mild to moderate AD.

He added that development of impactful treatments for Alzheimer and other neurodegenerative diseases of aging have failed for decades, however, GRF6019 displays an innovative approach to successfully treating Alzheimer’s disease by focusing on multiple underlying mechanisms of disease and the data fuels the development of GRF6019 and more therapies for AD.  

For the uninitiated, Alkahest focuses on treating age-related diseases and neurodegenerative with advanced therapies targeting the aging plasma proteome. The company’s pipeline contains numerous therapeutic candidates like protein-targeted interventions which intends to reduce the biological processes of aging.

Source Credit: https://www.alkahest.com/alkahest-announces-positive-top-line-data-from-phase-2-study-in-mild-to-moderate-alzheimers-disease/