Alkahest Doses First Subject in Phase 2 GRF6021 Trial

Alkahest announced dosing of the first subject in a Phase 2 clinical trial of its proprietary human plasma fraction, GRF6021, for the treatment of Parkinson's disease with associated mild cognitive impairment or dementia.

"This achievement marks a significant milestone for Alkahest in the development of GRF6021 and highlights our commitment to serving patients suffering from Parkinson's disease," said Karoly Nikolich, Ph.D., chairman and chief executive officer of Alkahest. "Current treatments for Parkinson's disease only partially address its symptoms and the need for new therapies, especially for non-motor symptoms such as cognitive impairment, is clear. By targeting the aging plasma proteome, GRF6021 could potentially address this unmet need. We are pleased to have an organization such as The Michael J. Fox Foundation partner with us to help support this study."

"We are committed to supporting new therapies that prevent, slow, or halt the progression of Parkinson's disease," Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation for Parkinson's Research, said. "Our partners at Alkahest share this goal and are working to provide Parkinson's patients with tangible results to improve their quality of life."

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and potential effects on cognition of GRF6021 administered as an IV infusion to individuals with Parkinson's disease who are cognitively impaired. Alkahest intends to enroll approximately 90 subjects who will receive GRF6021 or placebo for five consecutive days at week one and week 13 over seven months.

Alkahest, with partner Grifols, is developing GRF6019 and GRF6021, proprietary human plasma fractions that have been shown to enhance neurogenesis, improve learning and memory, and slow cognitive decline in animal models. These promising preclinical results validated these plasma fractions as potential treatments for neurodegenerative diseases. Phase 2 clinical trials with GRF6019 and GRF6021 are ongoing in Alzheimer's disease and Parkinson's disease, with other indications being explored preclinically.

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