Alkahest Announces Initiation of Phase 2b Clinical Trial
Alkahest, Inc. recently announced the initiation of a Phase 2b clinical trial of its orally administered small molecule CCR3 inhibitor, AKST4290. The company has dosed the first subject in AKST4290-205 (PHTHALO), which will assess the effects of AKST4290 on visual acuity with loading doses of anti-VEGF in treatment-naïve neovascular age-related macular degeneration (AMD) patients.
“The initiation of this randomized phase 2b trial represents an important milestone for our clinical development program in age-related macular degeneration. While the current standard of care for neovascular AMD is effective, the high burden of therapy leads to significant undertreatment and sub-optimal outcomes,” said Karoly Nikolich, PhD, Chief Executive Officer of Alkahest. “If safe and effective, adding a convenient oral agent to the treatment options for neovascular AMD would address a significant unmet patient and medical need.”
AKST4290-205 (PHTHALO) is a multi-center, double-blind, placebo-controlled dose-ranging trial designed to evaluate the efficacy of AKST4290 in treatment-naïve neovascular AMD patients after three loading doses of anti-VEGF (aflibercept) therapy. Subjects will be randomized 1:1:1 to receive AKST4290 400 mg twice daily, AKST4290 800 mg twice daily, or placebo. The primary endpoint of the study is mean change in best corrected visual acuity (BCVA), per the Early Treatment Diabetic Retinopathy Study criteria. Key secondary endpoints include safety, time to PRN injection with anti-VEGF per defined criteria in the AKST4290 arms only, mean number of anti-VEGF injections, and the proportion of subjects with a BCVA change of ≥ 15 letters. Alkahest intends to enroll approximately 150 patients across 25 sites in multiple countries.
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 and neovascularization of AMD while also acting more broadly to reduce inflammation associated with many other age-related diseases. The molecule is currently being tested in Parkinson’s Disease with additional indications being explored.
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 more information, visit www.alkahest.com.
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