Alkahest: phase 2 clinical trial of AKST4290 in Parkinson’s disease
Alkahest, Inc., a clinical stage biotechnology company focused on developing transformative therapies to treat age-related diseases, today announced the dosing of the first patient in a phase 2 clinical trial of AKST4290, an orally administered CCR3 inhibitor, for treatment of Parkinson’s disease. The trial, AKST4290-211 (TEAL), is funded in part by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and will evaluate the effect of AKST4290 on motor function and activities of daily living in patients with Parkinson’s disease.
“Evidence suggests that the immune system plays an important role in the development and progression of Parkinson’s disease, a disease which impacts nearly one million Americans,” said Karoly Nikolich, Ph.D., chief executive officer and chairman of Alkahest. “AKST4290 suppresses immune-mediated pathways and chronic inflammation and, if effective, could represent an important step forward in the treatment of Parkinson’s disease. We are thrilled to have the support of The Michael J. Fox Foundation, the world’s largest nonprofit funder of Parkinson’s research, in advancing this new program.”
Todd Sherer, Ph.D., chief executive officer of The Michael J. Fox Foundation, said, “Patients’ greatest unmet need is a therapy that prevents, slows or halts the progression of Parkinson’s disease. AKST4290 presents a novel approach toward that goal, and we’re keen to better understand its potential impact for the millions living with this disease and their loved ones.”
AKST4290-211 (TEAL)is a double-blind, placebo-controlled study that will enroll approximately 120 subjects. Subjects will be randomized to 400mg AKST4290 or placebo administered orally twice daily. The AKST4290-211 (TEAL) study includes 12 weeks of treatment and 30 days of follow-up. The primary endpoint is motor function at Week 12 in the practically defined off-medication state, measured by the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 3. Secondary and exploratory endpoints include safety and tolerability, and various clinical and functional endpoints in the on-medication state.