The Eyesight Sessions

Welcome to the Eyesight Sessions, a new series focused on the people in the Ophthalmology and Eyecare markets. These interviews are designed to focus on leaders in the space; their journey, their influences, what they are currently working on and their passions outside of eyecare.

In the first edition, I spoke with Jelle Kleijn , Global Head of AKANTIOR at SIFI

Firstly, for those in my network who may not be familiar, can you give us a brief introduction to yourself and your role at SIFI?

Yes sure, so my name is Jelle Kleijn, I’m 41 years old and father of 3 lovely girls, partner of Marjolijne and in my daily life I am the Global Head of Acanthamoeba keratitis at SIFI spa. In this role over the last four years, I have led the team that has developed the first approved treatment for this ultra-rare disease, and I have to say horrific eye infection.

Working in the rare disease side of ophthalmology, awareness and education must be hugely important. Can you tell us more about AKANTIOR, the years of research behind it and why it is so vital that treatments become available for patients suffering from acanthamoeba keratitis?

Yes, I could spend days on this topic alone. For all rare diseases, awareness is key. It's key to an efficient referral to specialists that have an expertise in this disease. But in a disease like Acanthamoeba keratitis, it's actually even more important because we are dealing with an acute situation where things can progress rather quickly into a situation where the prognosis is really bad, potentially blinding.

In the initial phase of the disease, it is often misdiagnosed for a much more prevalent form of keratitis leading to patients receiving treatment that is actually detrimental to them. Early recognition is quite difficult, and I think ophthalmologists may only meet one patient in 4 or 5 years that show these signs.

The main risk factors are wearing contact lenses and exposure to water. Patients with AK are often exposed to extreme levels of pain because the acanthamoeba is literally ‘eating’ the front of the eye. So, whilst this disease is very rare (1-4 per million) it needs to be at the forefront of clinician’s minds in order to recognise it at early stages and increase the opportunity to make a difference. Awareness is very important.

Currently patients are treated with combination therapies, which are compounded or imported and used off-label, with availability issues. Doctors use what they can get their hands on, so if you get the disease in Amsterdam or in Antwerp you will likely get a different product and paradigm of treatment because there are no guidelines for this disease. Typically, you need to treat patients really intensely in the beginning to target the active Acanthamoeba and then continue treating for months and sometimes years. 1 in 4 patients actually require at least one surgical procedure to restore vision or remove the infective burden.

Over the last 20 years, SIFI started to do preclinical research to develop polihexanide as a drug candidate and in a pan-European collaboration with top clinicians and researchers with expertise in AK, we developed a comprehensive preclinical and clinical package with the first Phase I and Phase III randomized trails in this disease ever. This was the basis for 2 orphan drug designations and the pending EU approval.

It was recently announced that the CHMP (Committee for Medicinal Products for Human Use) has adopted a positive opinion recommending the approval of AKANTIOR. How significant of a milestone was this for you and what future announcements should people watch out for?

This was a very big milestone, and I am very proud of the team who have worked really hard during this procedure to get where we are, and when I say the team, I count all of the external partners beyond SIFI too because lots of brains have contributed to this. With such a rare disease there are always data gaps and lack of understanding with need for alignment but in every instance the team succeeded.

?There were lots of celebrations when this was announced, but at the same time it is the start of a new phase for AKANTIOR. We are going to launch into Europe and into markets that are totally new for SIFI like Germany. We are accelerating new drug applications with the FDA and at the same time we are continuing to develop the product towards potential new indications. One that we are particularly focused on is fungal keratitis, which has a similar unmet need and are planning to move to clinical studies next year.

?There are a lot of things happening and we are not a big organisation, so everyone is onboard to make this a success.

You mention there your work with external teams, how important has SIFI’s collaborations with organisations such as the Acanthamoeba Keratitis Eye Foundation and partnerships with companies like Avanzanite Bioscience been in driving AKANTIOR forward?

So the AK Eye Foundation is the first and only foundation advocating for those who have been unfortunate enough to go through this disease and Juliette Vila Sinclair-Spence is the President. She went through her own experience a few years ago and she has taught me a lot about the permanent effects that the disease can have on someone’s life. 4 years ago, before my first day at SIFI I went to meet her to understand what this disease does to a person and their family, what it takes to go through it, to make sure that from the beginning I had an understanding and my priorities set to help the patients. That interview was captured as a video (see below) where she shares her story.

Ever since then we have collaborated to raise awareness, forge partnerships and capturing a very accurate patient journey. SIFI has helped the AK Eye Foundation by supporting with fundraising events because we feel that strong collaboration is key. The AK Eye Foundation has been a key stakeholder for us from the beginning

Our partnership with Avanzanite Bioscience is enabling us to bring AKANTIOR to all patients in countries SIFI is not present in, across Europe. This way we can ensure that together we can ensure all patients can gain access to treatment. This means that everyone effected in Europe will be able to receive this first to be licenced product.

Looking at your own journey into the eyecare space, could you tell us more about how you came to join SIFI back in 2020 and how your previous experience in other areas of pharmaceuticals equipped you with the skills to lead the AKANTIOR project?

AKANTIOR is SIFI’s first orphan drug and once there was confidence in it’s development over the last 15 years and a launch became a possibility, SIFI began to look to add someone with this type of expertise to the company to lead the team. I was connected to SIFI through a mutual connection, and I was selected to prepare around 4 years ago to come on board to do this.

?In the past, I’ve been working on a range of orphan drugs, mainly in oncology and haematology, launching products for companies facing quite similar challenges with some targeting both acute and ultrarare combinations. This experience that I built has equipped me well for leading the launch of AKANTIOR.

?I have a scientific background with my first years working within the medical departments of pharmaceutical companies working with market access and pricing as well as marketing and brand lead roles. I suppose this broad range of experience in drug development make me a good candidate for SIFI as I am now working daily with cross functional teams to reach our objective and I have a good understanding of what each of them has to do. I’m not the expert but my experience helps me to know what the priorities should be.

?I had zero experience in ophthalmology before this but obviously SIFI has over 85 years of experience there.

The ophthalmology industry in particular is very much all about the people. So, who has had the biggest influence on your career so far?

There are many, too many to mention here in this interview. But if I reflect, there have been a few key moments in my career, even when doing my PhD and working in the laboratory of a spin off contract research organization, the CEO of that company, Thomas Cremers , inspired me into exploring the world of biotechnology and pharmaceuticals so he has definitely been one of the key influences on the direction of my career.

During my work at Teva and Amgen, one of the key names that jumps out is Jan van Bodegom . He is actually an external collaborator that I worked with and a mentor of mine in the world of patient centricity. He designed and founded his own breast cancer hospital h

ere the patients is really at the centre and outcomes are defined by success measure informed by the patient. He really was an inspiration for how I think and how orphan diseases should be handled. The number of patients means that every journey is unique, but there are still some commonalities that you can help improve.

?Within SIFI, there is obviously Professor John Dart (Moorfields) who is the world leader in this field of Acanthamoeba keratitis. His passion, his drive and his expertise knows no boundaries. He knows everything about each patient being treated in his centre and this centre was the key in the UK and probably the whole of Europe, and he is just a very kind and warm-hearted person. An inspiration and definitely a compass for me to follow.

And another is Juliette Vila Sinclair-Spence . Similar drive, in a very different way. She has no filter, just emotions and heart coming out but this way you can truly learn what she has gone through. I really use those experiences as an inspiration to make sure that in future people have a better journey.

?For me, working in the orphan drug space, people like Prof. Dart and Juliette are key because they will give you the satisfaction that you, not just as a company but as a person, are making a huge contribution to care because you can see and feel it.

Looking at the wider ophthalmology space, which areas of research or treatments excite you the most? Where do you see the most innovation?

This is quite hard to judge, I’ve been working on AK for around 4 years but I have stayed on this little island of expertise to gain all the knowledge that I need so I don’t claim to be an expert on all areas. I am fascinated by the level of technology being employed to cure diseases for this very delicate organ, the surgical techniques being developed, what people can do to restore vision is amazing. The eye itself is a very protective barrier, very hard to penetrate with drugs and that is a challenge for us. The dosing schedules and treatment guideline improvements have shown to be so effective in increasing the effect of our product and I believe there can be so much development with this to continuing driving results with the combination of product and protocol.

?Beyond this, monitoring techniques for diagnosis during very early stages of a diseases, before it is even recognisable by a clinician, and without taking a sample. This space is going through huge innovation, and I think this is where we can have more victories. If we are fighting eye diseases in their infancy, then we can cure them faster. Patients will be happy; doctors will be more successful in treatment without the need for surgery and payers will be happy as thy are not dealing with patients who have long lasting effects of advanced disease. This will hugely improve eyecare and will be the space that I will be monitoring closely.

Where is the best place that your role in eyecare has taken you? Any favourite conferences or events?

I travel a lot to find conferences focused on the anterior segment that include keratitis. These are usually small conferences but means that there are lots of interactions with people who are really interested in this area.

They want to learn and improve their care which I like. EUCornea is the biggest, but also each of the national ophthalmology conferences where there are a lot of local ophthalmologists so you can find the majority of specialists in that particular country. I get around Europe a lot to new places a lot.

If you weren't working in the medical/healthcare space, then what would you be doing?

I love motorcycles and water sports so I actually think I would be doing something related to that if I wasn’t in the healthcare space. My first job ever was at the surf club teaching so maybe something like that, windsurfing, kitesurfing, stand up paddle boarding, wakeboarding, everything with water is appealing and lines up with my passions.

When you aren't working on AKANTIOR, where can we find you? Any more 33 hour SUP races on the cards?

Indeed, it was actually 2022 when I did that SUP race (220km) across 11 cities in the north of the Netherlands to raise funds for AK awareness. That race I did solo and I am doing it again this year but as part of a team, there are 5 stages and I will only be doing 2 of the last ones which will total 74km and still 10 hours of paddling. So I need to prepare for this.

This is in September, and later that month we are organising a SIFI run called AKtivity. We will run from our headquarters in Sicily, as high as possible up Mt Etna which is around 32km in distance and 2500m of elevation. An uphill battle and again raising awareness for AK so it is supposed to be tough, painful, a true challenge to mind and body. All the proceeds will go to the AK Eye Foundation to help their future.

So we are training for this too, I am a tall Dutchman so running uphill is the last thing I am built for but it is a challenge that I do like and I’ve found who are enthusiastic about the challenge.

Some will do it in a relay, and we will also organise a run at the boulevard in Catania where the SIFI story started so everyone can get involved. Also being by the water is another significant link to awareness as people should always take out their lenses before exposure to water.

Well we all know I like my running challenges too so I may have to send Fabrizio a message to see if he will invite me out to join in

Yes, either the boulevard or the one up the hill, you can decide.

Running up Mt Etna doesn't sound like too much fun, even for me, but what a great cause.

Huge thanks to Jelle for connecting with me to share his journey with AKANTIOR and insights into the space. Make sure to follow him and SIFI for upcoming further announcements regarding this project in Europe and globally.