SIFI announced the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency has issued a positive opinion concerning Orphan Drug Designation (ODD) for polihexanide in the treatment of fungal keratitis.

This designation follows the positive opinion of Committee for Human Medicinal Products adopted in May and the COMP positive opinion dated March 30 of this year for the medicinal product AKANTIOR (polihexanide 0.08%) in the treatment of acanthamoeba keratitis. SIFI expects to receive the decision of the European Commission for marketing authorization in August.

Polihexanide received an ODD in fungal keratitis from the FDA in February 2022.

Fungal keratitis, a severe infection of the cornea caused by fungi such as Fusarium, Aspergillus, and Candida species, is a significant cause of ocular morbidity and unilateral blindness worldwide. Although rare, this condition can lead to substantial vision loss if not treated promptly. Currently, no approved treatments exist for fungal keratitis in Europe, Japan, Asia, and most other regions globally.

COMP's positive opinion concerning ODD for fungal keratitis is based on SIFI's in vitro, ex vivo and in vivo studies on standardized strains, demonstrating the efficacy of polihexanide against the most recurring species in fungal keratitis, such as Fusarium, Candida and Aspergillus. In vivo study were performed in collaboration with Gazi University (Ankara, Turkey).

Additional studies on human ocular isolates are ongoing to potentially confirm the efficacy of polihexanide in fungal keratitis.

SIFI plans to initiate clinical trials in patients affected by fungal keratitis in 2025. The company will seek Contract Research Organization (CRO) pitches for a Phase 2 clinical trial in Q4 2024. SIFI will focus its clinical development program on two major geographies, such as the United States and Europe. A potential CRO partner should demonstrate extensive experience in ophthalmology and rare diseases, and a global presence.