From the June conference call, Question Now

From the June conference call,

Question

Now moving to clinical questions. What are management's thoughts on Brilacidin and inflammatory bowel disease? The interim data you released seems very promising.

Leo Ehrlich

Yes indeed. We're extremely excited about what we've been seeing with Brilacidin in IBD. It's really a novel non-corticosteroid non-biologic treatment that I think will have a very good place in treatment of various disorders.

We posted a strong interim data through two cohorts 12 patients. Our clinical position as I mentioned earlier was seen in at least half of the patients treated, I got a well-tolerated safety profile and from our measurements of systemic absorption they're really negligible, they are very low.

Patient improvement in quality of life was also seen across the study. So, we used [indiscernible]. Not everybody does that. We did this as a component to clinical remission criteria to really set the bar and that supports objectives corroboration of the patient responses. So that really helps us to anchor the results that we've seen.

We've actively engaged with multiple large pharmas, who have expressed an interest in Brilacidin inflammatory bowel disease. The pharma industry is quite interested in pursuing novel IBD therapies one of the more active therapeutic areas when it comes to dealmaking.

A recent example of an IBD deal just last week Johnson & Johnson signed a $990 million deal with Protagonist Therapeutics for preclinical compound with the bulk of the payout tied to advancing the compound into Phase 2 trials, that's where we are at this point. So, I essentially feel really good about where we are with Brilacidin in IBD.

Approximately a third of IBD patients find that existing treatments are not affective, that's why there's a high demand for a new treatment and a huge commercial opportunity.

As mentioned earlier we will be presenting topline findings from a clinical trial ulcerative proctitis, ulcerative proctosigmoiditis across all three cohorts in July in Boston at the DDT World Congress, as well as meeting with third parties interested in taking a closer look at our data.

Question

It's a question for Dr. Bertolino. I appreciate your mention of Brilacidin as a franchise. I think that's a nice word choice. I am especially also interested in your attempts to get the rest of the colon and the small intestine.

Can you provide any information about attempts to develop an enteric formulation for Brilacidin?

Arthur Bertolino

Yes, absolutely you're right on target with that and I think as I mentioned earlier, half of inflammatory bowel disease or more is Crohn's disease and Crohn's disease can happen anywhere in the GI tract. It's not just at the distal end like in the ulcerative colitis where we're getting the exciting results.

So, I think based on the results that we've gotten so far that we can get the drug into the GI tract without getting very much in the way of systemic absorption, it's an obvious direction that we would want to go to try to formulate a pill delivery.

So, it could treat throughout the GI tract and the technology for those kinds of deliveries have really gotten quite impressive in recent years that you can actually target certain areas of the GI tract where you can get pills to provide the active pharmaceutical ingredient to come out of the pill housing.

So, I think it would not be reinventing the wheel on how to do that. A lot of big pharms right now understand that themselves. Some actually have the technology available, but maybe lacking in terms of the right drug candidate with enough horsepower to treat the disease.

So that really just sets us up as Leo mentioned again toward a partnership. If that's appreciated, I think we could be in very good shape to move that in that direction without having to reinvent the wheel and really coming across the finish line effectively.

https://seekingalpha.com/article/4080068-inno...art=single