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Mati Therapeutics, Inc. |
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January 9, 2017 Issue |
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CEOCFO MAGAZINE |
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Revolutionary Punctal Plug Drug Delivery System for Treating Ocular Diseases Replacing Eye Drops and Solving the Compliance Problem in Glaucoma Patients |
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Chief Executive Officer
Mati Therapeutics, Inc.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 9, 2017
CEOCFO: Mr. Butchofsky, would you tell us about Mati Therapeutics? Mr. Butchofsky: We are working on drug delivery for the eye. Essentially you can view our technology as a replacement for eye drops. It is a combination drug/device, using a well-known device in ophthalmology called a Punctal Plug Drug Delivery System (PPDS) that goes into the tear duct of the eye and then it is anchored there and stays there for up to ninety days and delivers drugs directly into the tear film on a constant basis. You avoid the problems with compliance and the physical difficulties that patients, especially elderly patients that are diagnosed with glaucoma, face when taking eye drop mediation daily.
CEOCFO: To some people, putting something permanently in the eyes is may seem scary. Why is that not a concern? Mr. Butchofsky: It is really not in the eye itself, the device is placed in the tear duct which is in the eyelid. It is completely external to the eye. The device is only a couple millimeters long and is made of soft silicone so it basically just slides right in the tear duct. I have been wearing one in my eye lid for about eight months now and after the first day you notice a little foreign body sensation but after that, you do not even know it is there. The analogy we like to use is that it is almost like a driverless car. You are getting your drug and you do not have to worry about it and you do not have to go through all the physical problems with getting an eye drop in your eye. There are many other benefits on the medical side of this. When you take an eye drop, you have a tear response and you end up blinking and you lose most of the medication that goes down the tear duct and goes into your bloodstream. We prevent that from happening. We keep most of the drug in the eye and then we give a constant level of drug elution throughout the day as opposed to an eye drop where you get a big dose and then ten minutes later there is virtually nothing left on the surface of the eye. For diseases like glaucoma, you end up getting these peaks and valleys of intraocular pressure and unfortunately those peak pressure spikes that occur during the day in glaucoma patients are associated with irreversible loss of vision. We believe that we can prevent vision loss by having a constant drug level available on the surface of the eye and that is really the medical benefit that we are striving to achieve.
CEOCFO: Is this a basic office procedure? Mr. Butchofsky: It is a simple office procedure. The first time you have our device inserted you have to have the tear duct dilated and it needs to be dilated only to about one millimeter. Most patient’s eyelid is normally about .7 millimeter in diameter so it really doesn’t take much time or effort to get 1 millimeter of dilation. Then either the physician or an optometrist or even a staff member can place the plug, and it literally takes about five seconds for the plug to slide in. After ninety days you just come back to the office, they remove the old plug and reinsert the new plug. That whole process will take about a minute. It is not a burden for patients and it is not painful. It is quick and simple. It does not even require the physician’s time; one of their staff members can do it.
CEOCFO: Is this in use now? Mr. Butchofsky: We are in development so we are running Phase II studies. We are developing all of the categories of drugs to treat the front of the eye, so we are looking at glaucoma, anti-inflammatory agents, allergy drugs and drugs to treat dry eye.
CEOCFO: What has been the interest from the medical community; are they aware? Mr. Butchofsky: I think they are aware and I think the interest is very high. I think ophthalmologists and optometrists are routinely frustrated by the patient lack of compliance or their physical or mental inability to take their medications. It is well documented especially in chronic disease like glaucoma that up to 50% of patients do not adhere to their medications beyond six months. Compliance rates are terrible, so you end up with patients needlessly losing vision because they do not like the way their drugs are administered. That is frustrating to practitioners who have either treated them for glaucoma or removed their cataract and then their procedure does not go as well because the patients are unable or unwilling to take their drugs as prescribed. Physicians really are frustrated by that and I think there will be a high rate of adoption with our technology once it comes to market.
CEOCFO: Given the advent of some of the new healthcare regulations, is there a greater focus on making sure patients are compliant? Mr. Butchofsky: I think simply that physicians will be able to achieve get better patient outcomes if the patient is getting the drug they need, whether its to treat glaucoma or following cataract surgery. If you are spending the money to get cataract surgery but have to rely on the patient to take their anti-inflammatory agents after surgery, that is where the system can break down. You will naturally get a better surgical outcome if the patient has less inflammation, i.e. they use our product to ensure they are getting adequate anti-inflammatory medication in their eye on a constant basis. In glaucoma, what routinely happens is patients will come back and have their pressure checked and they will not be as controlled as the physician would like. In many cases, that failure is due to lack of compliance and not necessarily lack of efficacy of the drug. The physician ends up prescribing another eye drop adding a drug which further exacerbates the poor compliance. We think we can stop that chain which ultimately ends up with more patients getting surgery to control their eye pressure. If you reduce or eliminate the reliance on patients taking their medication by using our device, then there is greater potential for the patient’s eye pressure to stay controlled and you can avoid adding multiple medications or taking patients to surgery. We think we can reduce the cascade burden of enhanced care that is the result of poor compliance.
CEOCFO: Where does cost come into play? Mr. Butchofsky: In our internal forecasts we have assumed price points that are below the existing branded molecules currently on the market. We think we can actually save the system money in direct expenses but also in the progressive nature of treatments that we think we can reduce or eliminate.
CEOCFO: What is the timetable you are anticipating? Mr. Butchofsky: We are raising funds now and anticipate getting two anti-inflammatory into Phase II studies next year. Following successful Phase II programs, we anticipate that the first anti-inflammatory could potentially initiate a Phase III trial around the end of 2017 which means that we would be submitting that data in 2018 to the FDA and potentially on the market as early as 2019. We are getting close to two years away from approval with our first product.
CEOCFO: Is the concept fairly easy for the investment community to understand and are investors interested? Mr. Butchofsky: This has a very different risk profile because essentially we are repurposing drugs that have already been shown to be safe and effective in the eye. We are reformulating them in our delivery system. It has a very different risk profile than a biotech company that has a new molecule looking for a new indication. We already know the drugs we are putting in this device work. It is just a factor of getting the right drug load and delivering it in a way that is comfortable and easy for the patient to tolerate. We think we have already shown that by virtue of having already treated about a thousand patients in clinical studies, so our experience is already quite broad. We think our message resonates well both with the investment community as well as with the physician community.
CEOCFO: What has been the response from the patients? Mr. Butchofsky: Patients love it. When we have had patients that have been on chronic eye drop medications and then are exposed to the plug and they go through a six or twelve-week study, about 90% of those patients want to enroll for extension trials. The patient perspective is great and the feedback we get is that they do not have to do anything. The device is comfortable, it does not irritate their eye and they do not have to remember to take their eye drops and that is really important especially for patients that are on multiple drugs.
CEOCFO: What have you learned from your previous experience about bringing new products to market, dealing with science and the frustration of how long it all seems to take? Mr. Butchofsky: The one thing you can generally count on in drug development is it always takes longer than you think it will and as a result it always costs more than you initially plan for. The development pathway is never a straight line and you always must expect the unexpected. However, we are now at a stage where we have manufactured about a dozen different batches and tested multiple devices in patients. We get very consistent manufacturing. The clinical study results are getting more consistent. We have worked through and fought through and gotten through several iterations of the device design. All these things you would think are easy to do but each pose their own challenges. We are at a stage now where we are ready to make this a commercial enterprise and we are looking forward to doing that over the next two years.
CEOCFO: What will be the plan to reach physicians? Mr. Butchofsky: It all depends. My partner and I are both old Allergan alumni. We grew up in eye care. We both have been responsible for launching commercial organizations. We do not have any trepidation about launching our products ourselves, at least in the US market. We will definitely seek one or more partnerships outside the US. We are at a fork in the road and we are discussing whether we want to take on a partner now, possibly someone who could launch one or more products globally, or whether we want to license products for someone else to launch outside the U.S. I think that decision will largely be made over the course of the next year.
CEOCFO: Would you give us an idea of the market size? Mr. Butchofsky: Glaucoma is probably the largest market and one that probably has the greatest medical need. Close behind that, is the dry eye market and there is a new product from Shire and they are doing a big consumer marketing campaign for a product called Xiidra™ and using Jennifer Anniston to highlight that product. Punctal Plugs would be a natural to use with dry eye products because Punctal Plugs have traditionally been used to treat dry eye and they block the outflow and drainage of tear so you get more tear on the surface of the eye. Therefore, putting a dry eye molecule in a Punctal Plug makes a lot of sense. The anti-inflammatories are a great market. There is about 3.5 million cataract procedures done just in the US every year. Most of those patients get an antibiotic non-steroidal and a steroid so we are developing a non-steroidal and a steroid, which would be big opportunities. The final one is allergy and patients who suffer from ocular allergy will appreciate this. Typically, the allergy season lasts anywhere from six to eight weeks depending upon what part of the country you are in. The potential to place a Punctal Plug right as the allergy season is about to start and have your allergy medication on board throughout the whole season is something a lot of patients who suffer from ocular allergies will greatly embrace. These are all large and growing markets, high need across all these markets and one that we are very interested in pursuing. Overall, the current eye drop market is worth $4 billion and we think all of that could be cannibalized by our technology.
CEOCFO: What might someone miss when they first look at Mati Therapeutics? Mr. Butchofsky: I think there are other sustained delivery technologies that are out there but when you look at and compare and contrast the other available technologies, I think we stack up better than the other options. This includes how the drug is delivered, but also about how patients tolerate the device. Additionally, unlike some devices, our device does not pose a cosmetic issue for patients yet our device is easy for both patients and physicians to identify. On the medical or scientific side, we have constant surface area that is exposed to the tear film and that eliminates one of the variables in terms of our elution rates and how much drug we can consistently deliver to the eye. When you compare all the technical aspects, the patient tolerability, the lack of cosmetic issues, we really think our technology stacks up as good or better than anything that is in development in this therapeutic area. |
“I think ophthalmologists and optometrists are routinely frustrated by the patient lack of compliance or their physical or mental inability to take their medications. It is well documented especially in chronic disease like glaucoma that up to 50% of patients do not adhere to their medications beyond six months. Compliance rates are terrible, so you end up with patients needlessly losing vision because they do not like the way their drugs are administered.”- Bob Butchofsky
Mati Therapeutics, Inc.
Contact: Bob Butchofsky (512) 329-6360 bbutchofsky@matitherapeutics.com
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Bob
Butchofsky