Given urgency to treat, SIFI has established a dedicated cross-functional team to accelerate the launch of polihexanide monotherapy in Europe and the United States.
Catania, Italy – Dec. 7, 2020 – SIFI, a leading ophthalmic company, is pleased to announce the recent appointment of Jelle Kleijn, PhD, as Global Head of Acanthamoeba Keratitis.
Jelle will lead the efforts aimed at developing and making polihexanide monotherapy available to Acanthamoeba keratitis (AK) patients. Given the urgency to effectively treat AK to avoid blindness, Jelle leads a newly-established dedicated team to accelerate the launch of this potentially first licensed treatment for this severe eye infection in Europe, United States and elsewhere around the World.
A global pharma executive with extensive experience stemming from drug development, through medical, market access to sales & marketing, Jelle has long standing experience in leadership roles in large pharmaceutical and biotech companies. He and his team have been directly responsible for delivering new treatments to patients suffering from rare and often acutely life-threatening diseases. Jelle holds a PhD and a MSc in Medical Pharmaceutical Sciences from the University of Groningen.
"I have spent many years of my career working actively to find innovative treatment approaches for patients affected by rare and life-changing disorders. It is with great pleasure that I join the SIFI team to help advance treatment for AK, a devastating acute eye infection. No patients should feel left behind as my mission is to make sure we help finding everyone with this severe eye infection, and being able to provide them with an approved treatment, as early as possible" said Jelle Kleijn PhD.
“We are pleased to welcome Jelle Kleijn to the SIFI team,” comments Fabrizio Chines, Chairman and CEO, who continues: “Acanthamoeba keratitis is an ultra-rare acute infection of the eye that potentially leads to blindness, and eye loss. Jelle experience matches the unique challenges that our organisation faces to bring SIFI’s first orphan drug to market and, more importantly, the first registered treatment for this severe eye infection. I’m confident that the appointment of Jelle will lead to a positive impact on Acanthamoeba keratitis patients around the world.”
SIFI has recently completed patient enrolment in the pivotal phase 3 ODAK trial, comparing polihexanide 0.08% monotherapy versus the combination of polihexanide 0.02% and propamidine 0.1%. SIFI expects top-line results in the second half 2021. Polihexanide has already been granted orphan drug designation for the treatment of AK in both the European Union and United States. It has taken 13 years for the development process of polihexanide as a high-dose 0.08% monotherapy to reach this point. Notably, if approved, it will become the first medicine to be licensed for AK globally.
Polihexanide is an investigational disinfectant, a polymer, in development for the treatment of AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is locally administered as a high-dose 0,08% monotherapy, unlike current unlicensed alternatives which usually involve combination therapy with multiple eye-drop medications.
About Acanthamoeba Keratitis (AK)
AK is a severe corneal infection caused by the parasite Acanthamoeba. AK is a devastating acute eye infection presenting with unbearable pain and extreme light sensitivity. Each day of treatment delay increases the risk of blindness and eye loss. This means that appropriate and timely management is essential. AK is an ultra-rare condition affecting one to four per million people per year, but its incidence has been growing rapidly in recent years. No treatment is currently licensed for this acute eye infection in any country.
SIFI is a leading ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improve the quality of life of patients, exporting treatments to more than 20 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico and Turkey.