SIFI Receives COMP Positive Opinion on Orphan Drug Designation for Polihexanide in Treating Fungal Keratitis

ACI SANT'ANTONIO, Italy, July 22, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, is pleased to announce that the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA) 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 (CHMP) 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 (EC) for marketing authorization in August.

Polihexanide received an ODD in fungal keratitis from the US Food and Drug Administration (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 worldwide¹. 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 II clinical trial in Q4 2024. SIFI will focus its clinical development program on two major geographies, such as the USA and Europe. A potential CRO partner should demonstrate extensive experience in ophthalmology and rare diseases, and a global presence.

"As we are preparing to launch AKANTIOR^® (polihexanide 0.08%) in acanthamoeba keratitis across Europe, this COMP positive opinion concerning ODD for fungal keratitis reinforces our commitment to further invest on polihexanide and develop it in such rare disease where there is a high unmet medical need," said Fabrizio Chines, Chairman and CEO of SIFI. "We are eager to advance into the clinical development after encouraging preclinical data and double down on our efforts to develop therapeutic solutions for ophthalmic rare diseases."

ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information is available at www.sifigroup.com.

ABOUT AKANTIOR^®: AKANTIOR^® (polihexanide 0.08%) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. The EC and the FDA granted SIFI Orphan Drug Designation in the treatment of acanthamoeba keratitis. CHMP opinion was received in May, EC decision is expected in August 2024. In addition, COMP confirmed the designated orphan medicinal product status at the time of marketing authorisation of Akantior (polihexanide).

ABOUT FUNGAL KERATITIS: Fungal keratitis is a severe corneal infection that often results in blindness and eye loss.  The disease is most prevalent in tropical and subtropical climates.  According to The Lancet, annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America.  There are no approved treatments for fungal keratitis in Europe, Japan, Asia and almost anywhere else around the World. In addition to lack of approved medical alternatives, the incidence of fungal keratitis may be on the uptick due the global trend in general resistance to anti-fungal therapeutics.

1.  AAO Fungal Keratitis – Europe EPIDEMIOLOGY

Contact:

Sabrina Zappia
+39 3336999669
press@sifigroup.com