SIFI Gains COMP Orphan Drug Status for Polihexanide in Fungal Keratitis Treatment

ACI SANT'ANTONIO, Italy, July 22, 2024 - SIFI, a prominent international ophthalmic company based in Italy, has announced that the European Medicine Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on granting Orphan Drug Designation (ODD) for polihexanide in the treatment of fungal keratitis. This follows earlier favorable opinions from the Committee for Human Medicinal Products (CHMP) in May and COMP on March 30 for the medicinal product AKANTIOR® (polihexanide 0.08%) for treating acanthamoeba keratitis. SIFI anticipates a decision from the European Commission (EC) regarding marketing authorization in August.

Polihexanide had previously received ODD from the U.S. Food and Drug Administration (FDA) in February 2022 for fungal keratitis. This severe corneal infection, caused by fungi such as Fusarium, Aspergillus, and Candida species, poses a significant risk of vision loss and blindness globally. Despite its rarity, fungal keratitis can lead to substantial ocular morbidity if untreated, and currently, no approved treatments exist for this condition in Europe, Japan, Asia, and many other regions.

The positive opinion from COMP is based on SIFI's comprehensive studies, which demonstrated polihexanide's efficacy against the common fungi causing fungal keratitis. These studies included in vitro, ex vivo, and in vivo research on standardized strains, and the in vivo research was conducted in collaboration with Gazi University in Ankara, Turkey. Ongoing studies on human ocular isolates aim to further confirm polihexanide's effectiveness against fungal keratitis.

SIFI plans to begin clinical trials for patients with fungal keratitis in 2025. The company is looking for Contract Research Organization (CRO) proposals for a Phase II clinical trial, which is expected to start in the fourth quarter of 2024. The clinical development program will focus on the USA and Europe, seeking a CRO partner with extensive experience in ophthalmology, rare diseases, and a global operational presence.

Fabrizio Chines, Chairman and CEO of SIFI, expressed that the positive opinion on the ODD for fungal keratitis underscores the company's commitment to developing polihexanide for rare diseases with high unmet medical needs. Chines highlighted the encouraging preclinical data and SIFI's eagerness to advance clinical development and invest in therapeutic solutions for ophthalmic rare diseases.

SIFI, established in 1935, is a leading international ophthalmic company headquartered in Italy. The company operates an integrated business model encompassing research and development, manufacturing, and commercialization in both pharmaceutical and biomedical sectors. SIFI exports to over 40 countries and has a direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates.

AKANTIOR® (polihexanide 0.08%) is poised to become the first approved drug for acanthamoeba keratitis treatment globally. This anti-amoebic polymer targets both trophozoites and cysts of the protozoan acanthamoeba and is formulated at a concentration of 0.8mg/ml (0.08%) for single-dose eye drop administration. The EC and the FDA have granted Orphan Drug Designation for AKANTIOR® in treating acanthamoeba keratitis, with the CHMP opinion received in May, and an EC decision expected in August 2024.

Fungal keratitis is a severe corneal infection that can lead to blindness and eye loss, most common in tropical and subtropical regions. The Lancet estimates an annual global incidence of 1,051,787 cases, with the highest rates in Asia and Latin America. There are no approved treatments in Europe, Japan, Asia, or most other regions globally. Additionally, the incidence of fungal keratitis may be increasing due to rising resistance to antifungal treatments.