Alkahest Announces Peer-Reviewed Publication Demonstrating Safety and Tolerability of GRF6019 in Patients with Mild-to-Moderate Alzheimer’s Disease
GRF6019 was safe and well-tolerated, and patients experienced no cognitive decline and minimal functional decline
SAN CARLOS, Calif., Jan. 28, 2021 (GLOBE NEWSWIRE) -- 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.”
- 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.
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.
Grifols is a global healthcare company that since its founding in Barcelona in 1909 has enhanced the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries.
As pioneers in the plasma industry, Grifols is one of the largest plasma companies, with a growing network of donation centers worldwide. It develops this plasma into essential medicines used to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion. And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.
In 2019, Grifols’ economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced.
The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
Alkahest is a clinical stage biopharmaceutical company dedicated to discovering and 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.
For more information, please visit www.grifols.com or www.alkahest.com.
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