SIFI Secures European Patent for Treatment of Acanthamoeba and Fungal Keratitis; Set to Launch Akantior in Germany

SIFI was granted a new patent in Europe, titled "Formulation based on polyhexamethylene biguanide for use in the treatment of acanthamoeba keratitis and/or fungal infections." The patent (EP4216966), issued from rom the European Patent Office (EPO), covers a novel high-concentration formulation of polihexanide, its manufacturing method, and administration regimen for treating acanthamoeba keratitis (AK) and fungal keratitis (FK).

The patent was already been granted in Italy (IT102020000027155) in 2022 and in Eurasian countries earlier this year (EA047258). SIFI is now pursuing global intellectual property protection through additional patent applications in the US, Canada, Mexico, South Korea, India, Australia, Japan, and China.

The patent is based on findings from SIFI’s phase 3 clinical trial, where its Akantior (polihexanide 0.08%) treatment demonstrated an 86% clinical resolution rate for AK, with an average time-to-cure of approximately 4 months. The patent also covers the innovative dosing regimen of Akantior, which significantly improves patient quality of life. The dosing protocol includes 16 drops per day for the first 5 days, 8 drops per day for the next week, 6 drops per day for the following week, and 4 drops per day until the patient achieves clinical resolution. This regimen is a substantial improvement over the previously used off-label treatments, which required around-the-clock administration of multiple unlicensed drugs.

Following the European Commission’s approval of Akantior for the treatment of AK in August, SIFI is launching the product in Germany, where it will be available starting October 1, 2024. Additional European markets will follow, subject to local early access and reimbursement procedures.

SIFI’s polihexanide formulation has received two orphan drug designations (ODD) from the FDA for the treatment of both AK and FK, as well as an ODD from the European Medicines Agency (EMA) for FK.