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Envisia Therapeutics – OISASCRS 2015

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ENV515 is a proprietary, fully biodegradable PRINT (Particle Replication In Non-Wetting Templates) particle formulation of a prostaglandin analog, travoprost, with the potential for sustained intraocular pressure (IOP) reduction over as many as 6 months. In hypertensive beagles, a “rapid drop” in pressure was maintained over 8 months, Yerxa said, accounting for a 32% reduction in intraocular pressure (IOP). A phase 2a in cataractous glaucoma patients (n=20) is evaluating the compound in four doses (Travatan Z is being used in the non-study eye).

Well it’s a great pleasure to be here this afternoon to tell you a little bit about invisi of therapeutics bear with me as i go through a whole bunch of slides in five minutes so real quick about in vicia we spun out of liquidity technologies in late 2013 and we raised 25 million dollars to kick it off we were supported by led by kane and nea and since that time

We’ve really met some important corporate milestones we filed our first ind for a long-lasting prostaglandin for treating glaucoma that phase 2a trials underway we’ve also bought our second program into development that’s env 9054 post cataract inflammation we’ve been working diligently also on back of the eye formulations for both biologics and small molecules

And importantly we’ve added some great new board members with a lot of broad expertise in ophthalmology adrian graves and gary phillips and i can also say this week that we added red shipman as our chief medical officer and senior vice president of development so a lot of great progress here moving a this pipeline forward on rapid fashion you can see that our

Phase 2a glaucoma project is going to read out that that trial read out in mid year and then rotate into a 2b trial to be longer and bigger our post-operative inflammation program is starting a year later but it’s going to kind of rapidly catch up and development cuz it goes a lot faster and then in terms of partnerships in the back of the otter working on some

Early stage feasibility studies will hopefully translate in some meaningful licenses and some product development opportunities so real quick about print some of you have already seen this before but for those of you haven’t it’s essentially a particle molding technology manufacturing technology that allows us to take patterns etched on a silicon wafer and turn

That into essentially like a an ice cube tray that green material you see in the top middle we can fill that mold with virtually any substance drug polymer mixtures thereof and we can turn that into totally new dosage forms we can create particles that are on the order of fifty five nanometers up to several millimeters and we’ve industrialized this and scaled it

Up and we can make clinical trial material on site this is what some of these new dosage forms look like in a real quick collage you see prostaglandins steroids even highly concentrated microparticles full-length antibiotics like bevacizumab we can also blend these with sustained-release polymers to afford multi-month release profiles and we can even deal with

Very fragile cargo like rna and nucleic acids so our first program in development is env 905 it’s an inter cameral travoprost biodegradable formulation and our target product profiles essentially 24-7 control of iop at a twenty five to thirty percent reduction six months duration and less hyperemia than topical drops because we’re bypassing the conjunctiva easy

Administration through a custom injector you see down below and importantly fully biodegradable and the way we’re dose-ranging in the clinic is to develop we’ve developed two different sizes and we can iterate in between these so we can do multiples of each and get a full dose range clinically what this looks like clinically we studied this in hypertensive beagles

You see in the purple line a rapid drop in iop that’s maintained in this case for eight months from a single dose so really strong efficacy in beagles you can see on the left-hand side what this looks like in the anterior chamber resting nicely next to the target tissue our face to a study is kind of an interesting design it’s a designed to study glaucoma patients

Need to have a cataract taken out so this allows us to insert env 90 5 515 have a go for four weeks and we get steady state release safety and efficacy and that at the time of the cataract surgery we remove the implant see how much drug is left and get an aqueous humor sample for drug levels as well so it’s a very did a rich study we’re almost fully enrolled in

This trial and they’ll read out mid-year our second program you envy 905 is the biodegradable subconscious of dye footbed nate again we you understand the cataract world here we’re pretty much everyone gets on a topical steroid or in said post-surgery we’re trying to make this a little bit simpler where we can have a lower drug exposure and a three to four week

Control over inflammation and put it in the hands of the doctor and not the patient and eliminate all the hassle of drops in this situation we study this in a model of post cataract inflammation rabbits where we make a corneal incision and then do a weekly paracentesis that leads to a lot information see on the black lines of placebo ders all topically four times

A day every day you see in blue and then mv 905 same drug lower dose single dose is as effective as topical four times a day steroid so really nice results here we’re excited to get the ind filed later this year real quick couple things on back of the eye drug delivery we can make highly concentrated microparticles of antibodies like the vez is a map and we can

Also work with micronized api of small molecules we’ve tested this in rabbits and shown its protective in a veg f challenge model and i also put this in monkey eyes to show that are well tolerated real quick now for two seconds we are technology development company so we are pushing the envelope here we’re working on combination products or we can have linear co

Release of two different actives over a multi-month period of time and also we work with nanoparticles obviously we can engineer these for size and shape but also surface charge and modulus to get different kinds of ocular residency times and thank you very much for your attention

Transcribed from video
Envisia Therapeutics – OIS@ASCRS 2015 By OIS Ophthalmology Innovation \u0026 Investment