SAN CARLOS, Calif., July 09, 2020 (GLOBE NEWSWIRE) — Alkahest, Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today provided a corporate update.
“Since early this year, we have continued to make great strides in advancing our clinical assets, including initiation of a pilot phase 2 for our newest clinical therapeutic, AKST1210,” said Karoly Nikolich, Ph.D., chief executive officer of Alkahest. “Whilst continually ensuring patient and site staff safety during the SARS-CoV-2 pandemic, enrollment and treatment continue for our studies. During this unprecedented time, we are proud to continue our work with our investigators and partners to improve the lives of patients with age-related diseases.”
Alkahest has successfully completed three Phase 1 and 2 studies to date in 2020 which further the mechanistic and clinical understanding of candidate therapeutics GRF6019 and AKST4290.
- ALK6019-202 (NCT03765762) a randomized Phase 2 pilot study in severe Alzheimer’s patients (n=26) has met its primary endpoint, demonstrating that treatment with GRF6019 is safe and well-tolerated in this difficult to treat population. Additional biomarker analyses for this study remain ongoing.
- AKST4290-206 (STEEL) (EudraCT-2019-002821-31), a Phase 2 mechanistic trial investigating the impact of AKST4290 on choroidal blood flow in patients (n=14) with bilateral age-related macular degeneration (AMD), has successfully completed with biomarker analysis ongoing. This first study of concomitant clinical use of AKST4290 with anti-VEGF agents showed safety and tolerability consistent with prior clinical studies.
- AKST4290-102, a drug-drug interaction study investigating the impact of AKST4290 on the pharmacokinetics of multiple probe substrates and their key metabolites, has successfully completed.
After a thorough implementation of SARS-CoV-2 safety protocols and confirmation with investigators and site staff, all ongoing Alkahest trials are continuing with recruitment and/or treatment:
- AKST6021-201 (NCT03713957), a Phase 2 clinical trial of GRF6021 in patients with Parkinson’s disease with cognitive impairment.
- AKST6021-211 (NCT03981419), a Phase 2 clinical and mechanistic trial of GRF6021 in post-operative recovery following primary hip or knee arthroplasty
- AKST4290-205 (PHTHALO) (NCT04331730), a Phase 2b clinical trial in patients with treatment-naïve neovascular AMD.
- AKST4290-211 (TEAL) (NCT04369430), a Phase 2 clinical trial in patients with Parkinson’s disease.
- AKST1210-201, a pilot Phase 2 clinical trial in patients with end stage renal disease (ESRD) with cognitive impairment undergoing hemodialysis.
About GRF6019 and GRF6021
Alkahest and clinical development partner Grifols are studying GRF6019 and GRF6021 for the treatment of age-related diseases. GRF6019 and GRF6021, proprietary plasma fractions, are developed and manufactured by Grifols. In animal models, these plasma fractions enhance neurogenesis, improve age-related deficits in learning and memory, and reduce neuroinflammation. Development is ongoing with GRF6019 and GRF6021 in Alzheimer’s disease, Parkinson’s disease with cognitive impairment, and post-operative recovery, with other indications being explored.
AKST4290 is an orally administered CCR3 inhibitor that blocks the action of eotaxin, an immunomodulatory protein that increases as humans age and with specific age-related diseases. By targeting eotaxin and its downstream effects, AKST4290 may reduce the hallmark inflammation associated with many age-related diseases. Phase 2 trials are ongoing with AKST4290 in neovascular Age-related Macular Degeneration and Parkinson’s disease.
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 animal models 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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