Alkahest Announces Initiation of Phase 2 Study AKST1210-201 Exploring Treatment of Cognitive Impairment in End Stage Renal Disease PatientsStudy to explore extracorporeal removal of Beta-2 microglobulin
SAN CARLOS, Calif., June 01, 2020 (GLOBE NEWSWIRE) -- Alkahest Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today announced the initiation of a clinical study to explore the use of an extracorporeal medical device to remove excess Beta-2 microglobulin (B2M) from circulation for the treatment of cognitive impairment in patients undergoing hemodialysis for end stage renal disease (ESRD).
“A large proportion of individuals with end-stage renal disease who receive hemodialysis have cognitive impairment, which may be associated with reduced ability for self-care, poor adherence to dietary and fluid restrictions, and poor outcomes,” said Karoly Nikolich, Ph.D., chief executive officer of Alkahest. “Alkahest’s preclinical research has demonstrated that Beta-2 microglobulin, which is present at higher levels in older individuals, is drastically elevated in patients undergoing dialysis and may contribute to the high prevalence of cognitive impairment in these individuals. By reducing the amount of B2M in the plasma, we hope to introduce an effective way to lessen this impairment and allow patients on hemodialysis for ESRD to achieve improved treatment outcomes and quality of life.”
AKST1210-201 is a randomized, double-blind, feasibility and tolerability study investigating the use of the AKST1210 device connected to the dialysis circuit in 20 subjects with ESRD and cognitive impairment over a period of 20 weeks. Key objectives are safety and tolerability, as well as feasibility of conducting clinical trials with AKST1210 in this setting. Secondary objectives include measurement of removal of B2M, as well as improvements in clinical measures of cognitive, functional and quality of life assessments.
AKST1210 is an extracorporeal device which is connected in series with a standard hemodialysis circuit to remove B2M from the blood. B2M is an immune-associated protein that has been demonstrated to impair cognition in animals and may contribute to cognitive decline and other morbidities in patients undergoing hemodialysis for end stage renal disease. AKST1210 is manufactured via an exclusive supply agreement with a well-established device manufacturer.
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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