Hi AMM : Yes agree , 50% demonstrating acceptable “desired plasma levels “ great achievement but really important next giant leap forward will happen over next 6/9 months , hopefully will prove utrophin modulation treatment works for DMD boys ! Enjoy your bank holiday weekend ,Good luck everyone ! ------------------------------------------------------ “utrophin modulation programme is developing oral, small molecule drugs that increase the production of a protein call utrophin. Utrophin is a naturally occurring protein that is functionally and structurally similar to dystrophin. Utrophin is produced during the early stages of muscle fibre development but is switched-off in maturing muscle fibres, at which point dystrophin is produced to perform the same functional role. When a muscle fibre is damaged, utrophin is also produced during the early stages of the repair mechanism. Our utrophin modulation approach aims to use small molecule drugs to maintain the production of utrophin to compensate for the absence of dystrophin in DMD patients and so protect healthy muscle function.”
RE DMD clinical trials !
Gerry - re your comment “there was no change in the enzyme levels when patients received SMT C1100 compared to when they received a placebo.” Indeed many questioned this in the P1B RNS and it's been explained by a P.I. who happens to be Professor of Haematology on the "other" BB. Basically Glyn in his enthusiasm decided to mention this observation in original P1 tests (before diet was questioned and only 2 out of 12 absorbed enough of the drug) .. apparently those original results that saw a possible change in enzyme levels were a statistical aberration that should perhaps have not been mentioned at the time. (i.e. It was thought impossible that this first result was actually possible given the short time period) However human nature being what it is, clearly Glyn was incredibly enthusiastic in wanting to draw some positive conclusion and reported it. This has resulted in people wrongly drawing the conclusion that the recent P1B results were somehow disappointing in comparison! The time period for both of the tests were NEVER expected to produce a result better than the placebo ... the first time it happened was some sort of mistake in result analysis .... EVERYTHING IS AS EXPECTED .... NO DISAPPOINTMENT - Good luck everyone AMM (ps - once again at these low prices I would mark this IMHO a strong buy)
DMD clinical trials !
Admit being confused after yesterday conference call . GE stated “end of the year “ for results being ready pertaining to improved SMTC1100 new formulation - was wondering how they could test DMD boys so quickly ( latest trial has completed ) ? https://clinicaltrials.gov/ct2/show?term=Summit+Therapeutics&rank=2 Thanks to the other board explanation given ! waterloo01 28 Aug'15 - 11:22 - 19337 of 19338 Some explanation of how they think they can get the next formulation results reported by year end (this must also mean that they will RNS soon re start of new formulation trials?) The approach is that they are rolling the phase 1 in health volunteers and the 1b in DMD boys into a single study design which eliminates any delay between the two. As they have extensive experience and safety data on C1100, the number of doses and the length of dosing can be substantially reduced before they get to the chosen dose. Second and third generation will need to go through full phase 1 process so will take longer to come through. visionon 28 Aug'15 - 12:16 - 19338 of 19338 waterloo1. that's also how I heard it. another point that Glyn stressed was that they won't advance 2nd generation until they are sure they have the absolute best from a range of possibilities, and that existing C1100 at 50% absorption in any case reaches 4x the exon skipping market. I'm with SUMM on this one. I have seen too many companies fiddling around for too long trying to get the holy grail in new innovations and then finding they have been left behind and run out of money (some of it mine). SUMM don't want to be losing too much more time and if SMTC1100 works (IF) then a 50% applicability is still going to look very attractive to regulators and families, with the hope that formulation changes can still bring benefits to some of the other 50%. I would like SUMM to stick to their open-label start date. We have already lost time since SUMM set out a timetable a couple of years back.” ---------------------------------- Of course getting the drug into the blood stream “the desired plasma level ) is great . More importantly outstanding question remains for DMD boys “there was no change in the enzyme levels when patients received SMT C1100 compared to when they received a placebo.” So DMD boys need treatment for perhaps 6 months to confirm utrophin tap is actually turned on – demonstrate muscle regression improvement etc ( as seen in animal studies etc ) Fingers crossed for 2016 ! Good luck everyone ! P.S. not forgetting C-Diff results !
Takeover or Deal ?
Great presentation and Q/A session yesterday. Gave more insight into the current board thinking as I see it. I was very interested to listen to the answer regarding C.Diff and any potential partnering deal. As previously discussed, any partnering deal could be worth in the region of half a billion to Summit given the QIDP and fast tracking status SMT19969 has. So my point here is that unless the SP rises quickly on P2 results (expected in the next quarter) Summit could be seen as a takeover target at the current SP, which only values the whole company just below £100million. I would expect, being on NASDAQ, the SP will rise quickly following those +ve P2 results though and any takeover offer will be resisted by current shareholders given the huge potential/value in the DMD programme. Exciting months ahead. GLA
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