Alkahest Doses First Subject in Phase 2 Clinical Trial of Lead Candidate in Patients with Severe Alzheimer's Disease
- Category: Proteins and Peptides
- Published on Tuesday, 19 March 2019 10:46
- Hits: 572
Study will evaluate safety, tolerability and functional improvement in subjects with severe Alzheimer's disease
Results expected in the second half of 2020
SAN CARLOS, CA, USA I March 18, 2019 I Alkahest, Inc., a clinical-stage biotechnology company focused on developing transformative therapies to treat age-related diseases, today announced the dosing of the first subject with severe Alzheimer's disease in a Phase 2 clinical trial of GRF6019 in collaboration with development partner Grifols. The Company is also conducting a Phase 2 study of GRF6019 in mild to moderate Alzheimer's disease with data expected in 2019, and a second selected fraction GRF6021, in Parkinson's with cognitive impairment.
"In recent years, it has become evident that there is a complex, multifactorial pathology underlying Alzheimer's disease that available drugs and those currently in development fail to fully address," said Karoly Nikolich, Ph.D., chairman and chief executive officer of Alkahest. "Using our deep understanding of the plasma proteome, we have identified specific proteomic factors as the basis for this potential treatment for Alzheimer's disease. Patients at more advanced stages of Alzheimer's disease are rarely included in clinical trials, and this novel approach could provide a novel treatment option for these individuals."
This study will evaluate the safety, tolerability and potential functional benefit of GRF6019 infusions in subjects with severe Alzheimer's disease, defined as those with a Mini-Mental State Examination (MMSE) score between 0 and 10. Alkahest plans to enroll and randomize approximately 20 subjects who will receive GRF6019 or placebo for five consecutive days and be monitored over the course of 9 weeks. The trial's primary outcome will examine safety and tolerability with secondary endpoints measuring changes in cognition, function, and behavior in these patients.
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 developed and provided by Grifols. In animal models, GRF6019 and GRF6021 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, with other indications being further explored. Please see clinicaltrials.gov for more information about the Severe Alzheimer's study.
Alkahest is a clinical stage biopharmaceutical company dedicated to treating 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.