Thanks for referencing this.
Overall it's a nice updated presentation, where they also nicely highlight issues discussed on those seeking alpha articles and this board. Wonder if IR is paying attention to these platforms? :)
While the presentation looks good and they have their ducks in a row, there are two things that were of particular interest to me, one good and one not-so-good.
1. Good: I find it interesting that from the beginning of the OPRX-106 slides (17-22), they have changed OPRX-106 potential indications from Ulcerative Colitis (UC) to the more general Inflammatory Bowel Syndrome (IBS). IBS includes both UC (which is generally restricted to the colon) and Crohn's Disease (CD), which can affect any and all areas of the gastro-intestinal tract, but most effects most commonly seen in the Ileum and the Colon. The Ileum is the last part of the small intestine that feeds into the colon.
This is an interesting development as it would mean that when these OPRX-106 patients were getting their treatment, this was not only impacting on the Colon where the majority of the bacteria are that breakdown the cellulose membrane releasing the anti-TNF alpha, but that this was also impacting on the ileum right before the colon.
This could make sense for a couple of reasons. The carrot plant cells that encapsulate the anti-TNF alpha are vascular plant cells. These as per design are unable to be broken down by the digestive system until they reach the colon, where the return from highly acidic environment in the stomach and through the duodenum, jejunum, ileum and finally to a Neutral pH of 7 in the Colon which then allows bacteria to live which in turn break down the cellulose wall and thus releasing the anti-TNF to the target site in the colon.
However, one must also remember that once we get to the jejunum, the pH is between 7 and 9 (maybe too alkaline for most bacteria), and then in the Ileum is between 7 and 8, before entering the Colon with a pH of 7. Thus given the close proximity to the colon and the close pH, it may be entirely possible, that certain more robust bacteria are able to venture a certain distance into the Ileum where they already begin to degrade some of the cellulose walls and releasing the anti-TNF into the ileum too as well as then following on via the same mechanism into the colon. Thus treating both UC and the main locations of Crohn's disease.
Thus expanding the potential to both UC and Crohn's disease patients. Because these two issues are so similar interms of pathology presentation and treatment, I wouldn't see a particular problem with the FDA allowing Protalix to recruit both UC and Crohn's patients in separate arms of the Phase III.
I would suppose that the above benefit to the Ileum would have been noted by using the colonoscopy to just investigate a little further up than just in the colon. Looking forward to the full data presentation later.
Also this Crohn's development nicely potentially opens up another 3 billion in market for OPRX-106 to join.
2. Not-so-good: PRX-110, slide 26 has some annoying news, that the CF foundation 'acknowledged the need and the potential of PRX-110 for CF but declined funding for the current proposal protocol' and therefore Protalix on the feedback is amending the protocol and resubmitting it, which they plan to do with "the potential partner".
So, annoying that it wasn't approved on the first go, but good that they can resubmit and the statement of "the potential partner" should mean that they are in decent discussions based on the new Phase II data.
Overall good and looking forward to Fabry results in 2019 and to seeing the next clinical trials for 106 and 110 kick off hopefully by end of this year.
