Alkahest Inc., a clinical stage biopharmaceutical company, 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. Clinicaltrails.gov describes the study to assess the efficacy and safety of AKST4290 with aflibercept in patients with newly diagnosed nAMD (PHTHALO-205). The randomized interventional study is estimated to enrol up to 150 participants across 25 locations comparing 800mg + aflibercept, 1,600mg + aflibercept and placebo + aflibercept.
According the company, 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 the three loading doses of anti-VEGF (aflibercept) therapy. Participants will be randomized 1:1:1. The primary endpoint of the study is the 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. The novel experimental drug 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. The drug may reduce inflammation and neovascularization of AMD while also acting more broadly to reduce inflammation associated with many other age-related diseases.
Commenting onr the clinical milestone, Karoly Nikolich, Ph.D., Chief Executive Officer of Alkahest stated that, “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. 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.”