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January 30, 2017 Issue

CEOCFO MAGAZINE

 

New Injectable Controlled Release Drug Delivery Platform and Small Molecule Technology Showing Promise in Treating Eye Diseases Such as Wet AMD, Glaucoma and Corneal Graft Rejection

 

 

Dr. Jeffrey L. Cleland

President & Chief Executive Officer

 

Graybug Vision, Inc.

www.graybug.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 30, 2017

 

CEOCFO: Dr. Cleland, would you tell us the concept behind Graybug?

Dr. Cleland: We are focused on developing our own products using our platform technology that enables a substantial reduction in dosing frequency. The idea is to reduce the treatment burden that patients currently have with their therapy for diseases such as age related macular degeneration and glaucoma.

 

CEOCFO: Would you explain the technology?

Dr. Cleland: We have two technology platforms. The first one is work that was done out of the Wilmer Eye Institute many years ago that demonstrated that we can actually reduce the inflammation in the eye through a treatment procedure by putting a hydrophilic, or a water-loving, kind of surface on the polymers that we inject into the eye and that allows us to hopefully administer these to patients safely and get a long-term duration of exposure. The second platform technology that we developed is a prodrug technology that allows us to take drugs that are currently not amenable to our technology and make them useful with our technology. This then allows us to advance many of the compounds that would not normally be able to be delivered in a sustained released platform.

 

CEOCFO: How are you doing that?

Dr. Cleland: Basically, we are working on prodrugs that actually have a better compatibility so the idea is to covalently link, through degradable bonds, a part of the molecule that allows it to be more compatible with polymer systems. Once it is injected in vivo, it breaks it back down into the original parent compound. It is essentially the same as the approved drug, once it is released into the body.

 

CEOCFO: Is that common in medicine?

Dr. Cleland: Yes, it is common. The prodrugs are often used as way to get around, for example, first pass metabolism of drugs when they are taken orally so avoiding the metabolism potentially in the liver. Our approach is to make it more compatible with the polymer systems that we use and also to allow them to potentially link two drugs together through hydrolysable bonds. When you inject it, it is one compound but then the bonds hydrolyze and potentially provide either a single agent or dual agent as active metabolites. 

 

CEOCFO: Where are you with your various programs?

Dr. Cleland: We have a lead program in age-related macular degeneration (AMD) that is the wet form of the disease. Currently patients are taking approved drugs by an injection in the eye on average of about every six weeks. We have a lead program that hopefully can deliver once every six months or twice a year. That program is moving into clinical trials; we should be in the clinic in the third quarter of this year in patients with AMD and hopefully demonstrate proof of concept sometime towards the end of next year or the beginning of 2018.

 

CEOCFO: Is it painful or just more annoying to have to do it every six weeks, in addition to the cost and inconvenience?

Dr. Cleland: Patients’ eyes are anesthetized because the needle goes into the eye. They do have some pain and discomfort associated with the procedure. In addition to that, it takes several hours out of their day to go to the site and have this done by a specialized retina ophthalmologist.

 

CEOCFO: What are your next steps?

Dr. Cleland: The first program I outlined, for wet AMD, we will have in the clinic at the middle of this year. We will also have a glaucoma program that should be about six months or so behind that, so we will hopefully have something in the clinic for glaucoma at the first half of 2018. Our plan is to continue to build out the pipeline from there. We have synthesized over forty compounds. These prodrug compounds I mentioned, we are screening through them and we think we will probably have more than one to take into the clinic after we have narrowed down the lead compound.

 

CEOCFO: What have you learned so far regarding your GB-102 for wet AMD?

Dr. Cleland: I think that the key learning there was that we figured out a way to solve two problems. The solution I mentioned earlier, which is the hydrophilic or water-loving coating that we put on the particles, makes them less inflammatory. We have also learned how to make them aggregate in the eye, so when we inject them they aggregate together and form a single implant-like structure, which minimizes the chance of any visual disruption. We have also learned that the drug that we selected has some unique properties. It is SUTENT (or sunitinib) and it can actually deliver the drug for a longer period of time because it binds melanin. Even though our first program looks like the polymeric depot formulation itself lasts for a little over three months, the sunitinib actually stays in the eye for up to another three months, so the treatment lasted for six months in our animal studies. We now have a formulation that will potentially be once a year based on that technology and we will be talking about it in detail at the ARVO meeting (Association for Research in Vision and Ophthalmology) in May 2017.

 

CEOCFO: Would you tell us about wet AMD?

Dr. Cleland: Wet AMD is one of the major causes of blindness in the elderly. Typically, the onset is somewhere after age 65. What happens is that the macula, the major focal point of your eye which allows you to have your central vision, gets disrupted by blood vessels that start to push through from underneath the macula and causes loss of central vision. It is very severe so that you cannot see anything in the central vision of your eye.

 

CEOCFO: Has the medical community paid attention?

Dr. Cleland: We have a lot of interest and enthusiasm for our approach because we have done qualitative market research and the American Academy of Ophthalmology has also done some market surveys and every single one of those surveys demonstrates the number-one demand from the medical community is to develop an extended duration treatment approach for wet AMD.

 

CEOCFO: After they go through the first six weeks and then go ahead and go the six months, how can we be sure there will not be more damage in-between?

Dr. Cleland: In the clinical trial, we will be demonstrating that. Hopefully the patient should be coming back to the clinic once a month for evaluation both in terms of visual acuity, and also for the return of the fluid that will come back if the disease is progressing. We will have a really good understanding of the durability of our response at different dose levels.

 

CEOCFO: Is there much competition on the landscape and research?

Dr. Cleland: There is quite a bit of interest because the market is very much interested in having an extended duration product for this indication. There are several companies that are at or earlier than us in terms of their development stage, looking at taking the existing biologics such as Eylea® and putting them in a long-acting form. Our focus is on a molecule we think has superior efficacy because it targets at the receptor level inside the cells instead of binding to the ligand that binds to the receptor like Eylea. By blocking signaling inside the cells, our approach may provide a more consistent and robust response in AMD patients.

 

CEOCFO: What is your funding situation?

Dr. Cleland: We were fortunate to have Deerfield Management Company, L.P. lead a financing of $44.5 million at the end of April of last year. They were joined by OrbiMed Advisors, LLC, and Clarus Ventures, LLC along with Series A investor Hatteras Venture Partners and Maryland Venture Fund. We are in a strong position to continue to execute and obtain the data that I described earlier. In 2018, with successful clinical trial outcomes, we will have potential options for additional financing either through a private placement or a public offering.

 

CEOCFO: You have a lot of experience in development and biotech. What do you understand from the past that has been helpful?

Dr. Cleland: I think that on the science side, from my Genentech training and doing good science and making sure that we ask the right questions and confirm what we think we will see in patients based upon what we have observed already in animal studies, we will de-risk ourselves, our platform and our products as much as possible before we go into the clinic. On the business side, I think understanding the market requirements and demands that are out there so that we are designing a product that will be valuable for patients and physicians as well as potential partners down the road.

 

CEOCFO: Where do you see the medical focus on better outcomes, more efficiency and less cost, play into what you have developed and is it significant or just a nice extra?

Dr. Cleland: I think that is a fair question in the current environment. We feel that the drug that we are using is the primary active agent in our platform will be generic very soon in the US and generic in other territories and the fact that our final processing steps to put it into the platform are not overly expensive. Therefore, we believe we can be very competitive with the other biologic products that are already approved.  I believe in terms of cost, we can be competitive on cost and still make it affordable for payers and for patients. Some of the research that we are doing right now is to look at what they payers think with regards to this platform.

 

CEOCFO: Why pay attention to Graybug Vision?

Dr. Cleland: I think it comes down to something that is really important for both the patients and the physicians and the treatment burden. If you must choose between going to the doctor to have a needle put in your eye every six weeks or go blind, most people will opt for the needle so I think it really helps to have a product that can be dosed twice a year and eventually once a year to alleviate that burden.

 

 

“If you must choose between going to the doctor to have a needle put in your eye every six weeks or go blind, most people will opt for the needle so I think it really helps to have a product that can be dosed twice a year and eventually once a year to alleviate that burden.”- Dr. Jeffrey L. Cleland


 

Graybug Vision, Inc.

www.graybug.com

 

Contact:

Jeffrey L. Cleland, PhD

(650) 487-2800

jcleland@graybug.com



 


 

 



 

 


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