Good stuff Citrati. Thanks for bringing it over. Will have to see how this plays out over the next few months. See how things perk up in the EU as well.
“Potentially an IND sometime next year.” (00:29) (in reference to Alkaline Phosphatase)
Ribaxamase and Dell
(5:27) “you guys may have seen recently, as of this morning, we raised $12 million that came specifically in the preferred stock offering, from Michael Dell’s fund, MSD Capital. And that money was given to us because they decided they were going (5:40) to take a position in the company because of this specific issue. [ed: Ribaxamase, cdi and AMR]
We will be allocating some of our resources directly to manufacturing of this program both potentially for a phase 3 and for preparing for commercialization. It is a protein, so it does require an E. coli cell line to manufacture this particular product.”
(9:42) “And we are in the process of doing an HEOR [ed: Health Economics Outcomes Research, in reference to cost of cdi to hospitals] study right now where we’ll be able to publish and show that de facto.”
(10:27) “We do have an FDA meeting coming up at the end of this month. We do have Breakthrough Status on this particular drug, which means we get to have multiple FDA meetings. And this is a Type B meeting coming up. Which means we get to go (10:39) to the FDA and basically spitball [ed: is that what he said? is that CEO for “talk”?], what does that next study look like? What does that Phase 3 or Phase 4 study going to be? And what can we do from a label perspective? So we are very excited, obviously, to get to that meeting with the FDA later this month (10:52) and have additional guidance from that regulatory group.”
SYN-010
(14:25) “You can see that the Linzess—they really don’t sell much of that outside of the U.S. The EMA does not like the drug because it does have a black box, there’s a variety of issues with Linzess, and the other drug, Amitiza as well, from Takeda. (14:38)
So we feel pretty good after we’ve talked to some consultants (14:42) on the European Medicines Agency, that we will probably be approved in Europe, hopefully, in the not-to-distant future, and obviously we’ll be a competitor here in the United States. But we won’t (14:51) have a lot of competition outside the U.S. It’s a growing market, there’s a lot of people and there’s really nothing that works well at this stage of the game for those folks.
Building Capabilities
(15:38) “So as a company, as we pivot away from just doing pure R&D, and looking toward commercialization somewhere down the road, we really are starting to look at a different group of folks that are needed in the company, in addition to the people we have. So that’s what we consider “building capabilities” downstream. We have to have commercial/manufacturing capabilities, which is why we are very pleased that MSD Captial put cash in today. (15:57) But we are moving all these programs foward.” (16:00)
Alkaline Phosphatase
(16:46) We didn’t talk to you much about this, this is an up-and-coming drug, another enzyme, that we have, as human beings we usually make this enzyme in our bodies, however, over a period of time for some reason we don’t make enough of it. And this is—I call this spackle for the gut. (13:00) So over time you get cracks in your interstitial tissues and bugs can get from you intestinal track into your blood stream and cause a whole plethora of issues. This basically fixes that problem to some extent in our pre-clinical studies.
So we’ll be doing the same thing we did with the other drugs. (17:18) We are very good at delivery, we’re gonna deliver this enzyme to a particular place in the gut, where it will be released, it will not be systemically absorbed, againg it’s a set of amino acids, so it’s just going to be broken down, and it’s going to do the job. So we’re doing studies in Nat’s Syndrome, Protexia [ed: did not catch these names], IBD—a variety of experiments to see if we can move this thing forward. Again, we feel fairly confident given that A) an already created human enzyme that we will not have any issues, nor will we have any safety profile issues, as we go forward in this drug. The xx? intellectual property will be delivery and manufacturing of this particular compound.”
Questions and Answers
(18:00) “So, the question is, ‘what is the cost of the phase threes, for both drugs?’ The P2b/3 for SYN-010 is roughly $40-50 million, from soup to nuts, give or take. The program for Ribaxamase, we really haven’t identified that yet, we need to have our discussion with the FDA, to find out what we actually have to do, next. So we’re not sure at this point in time. A phase 3 would probably be three times larger than the trial we (18:34) did before, first from a statistical perspective, but again, we don’t know what that label’s gonna look like. And we don’t (18:40) know what they’re gonna be looking for. We’ll know in October. (18:42)
What did the Phase 2b for Syn-004 cost? 16 million. They’re not very long studies.” (18:33)
The question is, are we looking for partners? (19:26) Um, yeah we are. We have been for a period of time. SYN-010 is probably not a drug we would take forward on our own, you would need to build a relatively robust sales force, I think Synergy is a competitior in that space in the process of doing that (19:43). It’s probably not something that we would do as a company.
However, Ribaxamase, we may take that drug all the way ourselves, we’ll see what happens.” (19:49)
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