SAN CARLOS, Calif., Dec. 09, 2019 (GLOBE NEWSWIRE) — Alkahest Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, presented data this weekend from its phase 2a study, AKST6019-201, in mild-to-moderate Alzheimer’s Disease (AD). The study met its primary endpoint of safety and tolerability and key secondary endpoints measuring cognitive and functional performance indicated limited-to-no declines over the six-month treatment period. The clinical results were presented in a podium presentation Saturday, December 7th at the 12th Annual Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in San Diego, California.
“These data are encouraging and indicate that the GRF6019 plasma fraction is safe and well-tolerated, and that it may slow the progression of mild-to-moderate AD in patients who would have otherwise been expected to experience cognitive and functional decline over this period,” said Dr. Karoly Nikolich, chief executive officer of Alkahest. “The results of this trial support the continued study of plasma fractions in Alzheimer’s disease in a larger, placebo-controlled clinical trial, in collaboration with our partner, Grifols.”
The primary endpoint of the study was safety and tolerability, and the drug was found to be safe and well-tolerated in all subjects randomized to dosing with 100ml or 250ml of study drug GRF6019. There was no significant difference between 100 mL (n=21) and 250 mL (n=22) arms in adverse events. Most adverse events experienced by subjects were mild, and consisted of headaches, transient lab changes, infusion site extravasations, and transient blood pressure changes.
Secondary endpoints included measures of cognition and function, with no significant difference between the two dose levels. Subjects experienced no clinically detectable decline in cognition as measured by the 11-item AD assessment scale-cognitive subscale (ADAS-Cog11) and the Mini-Mental State Examination (MMSE) over the six-month study period. Additionally, subjects demonstrated only a small decline in function as measured 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.
All data below are presented for both treatment arms combined. Data are presented for evaluable subjects (those receiving at least 5 doses of GRF6019, n=43) and for completers (those receiving all 10 doses of GRF6019 and completing visit 19; n=39).
ADAS-COG11 measures memory, language, praxis and orientation on a scale of 0 to 70, where higher scores indicate worse cognition:
|ADAS-COG11||Evaluable||Baseline: 21.6 Final visit: 21.8|
|ADAS-COG11||Completers||Baseline: 22.2 Final visit: 21.8|
MMSE measures cognitive function on a scale of 1 to 30, where lower scores indicate worse cognition:
|MMSE||Evaluable||Baseline: 20.0 Final visit: 20.0|
|MMSE||Completers||Baseline: 19.8 Final visit: 20.0|
ADCS-ADL23 Measures the competence in performing basic and instrumental activities of daily living on a scale of 0 to 78, where lower scores indicate worse function:
|ADCS-ADL23||Evaluable||Baseline: 61.8 Final visit: 59.8|
|ADCS-ADL23||Completers||Baseline: 60.8 Final visit: 59.8|
CDR-SB measures a composite of a range of functional tests on a scale of 0 to 18, where higher scores indicate worse function:
|CDR-SOB||Evaluable||Baseline: 5.6 Final visit: 5.8|
|CDR-SOB||Completers||Baseline: 5.7 Final visit: 5.8|
About the study (ALK6019-201)
The Phase 2a ALK6019-201 trial 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 to either 100 mL or 250 mL of GRF6019 given by IV 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.
About GRF6019 and GRF6021
Alkahest and clinical and development partner Grifols are studying GRF6019 and GRF6021 for the treatment of age-related diseases. GRF6019 and GRF6021, proprietary plasma fractions, are manufactured 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 severe Alzheimer’s disease, Parkinson’s disease with cognitive impairment, and post-operative recovery, with other indications being explored.
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. 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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