Summit Therapeutics Share Discussion Threads

[visionon] 22/6/2016 10:46

Folks. good posts as ever.

I sense that the UK biotech sector will be relieved if the vote is to remain in the EU.

On c.diff does anyone here have a feel for possible annual sales potential ? I recall vancomycin being around $150m pa before the generics arrived on the block. Presumably if RZL is a new gold standard then the potential is at least $150m pa because medics would stop prescribing other alternatives that had worse recurrence rates. Thoughts welcome.

Looking again at the SUMM video featuring Dale and Mark having a chat Mark's closing comment that there is a need to get RZL into P£ and check results are "re-produceable" strikes a bell. many drugs fail at the P3 stage. I don't think RZL will fail but presumably potential partners will factor in the chance that I might be wrong !! ;)

Chrisatrdg - If your average is 5.8% higher than current share price that's not bad !!

[hugus maximus] 22/6/2016 09:34

in te USA last night BB's still saying "who cares about a little company in the UK with no money?" ... and ... "shouldn't Sarepta just buy Summit if this drug is any good?" !!!!!

[waterloo01] 21/6/2016 18:11

Good coverage.

[chrisatrdg] 21/6/2016 17:54

We are now attracting further coverage see below:

Summit Therapeutics PLC (ADR) (NASDAQ:SMMT) Is Hot On Sarepta Therapeutics Inc (NASDAQ:SRPT)’s DMD Tail

[chrisatrdg] 21/6/2016 17:39

Summit uses more than gut instinct to prove C.diff antibiotic's worth - see link below and includes access to Richard's Stock Tube interview today.I would add he has re-emphasised that they have funds to Jan'17 in order to deliver the results in Jan'17 for dmd.



XX proactive XX investors

[chrisatrdg] 21/6/2016 15:36

Today's conference

I have just finished listening to todays NY conference and think that it will only be a C-Diff deal that is going to give us any significant share price movement before next Jan'17. There is a long way to go with DMD and for me next Feb will be my 7th year invested here and currently I am showing a loss of £3k being minus 5.85%.However it is still a Strong Buy at current prices and not another 7 year wait for a significant return.Hey Ho.

I will be at the AGM

[chrisatrdg] 21/6/2016 15:14

Per Free-Money from the other board this afternoon:

'Another 'Buy' rating :



They're adding up :-)'

[chrisatrdg] 21/6/2016 12:29

I suggest that people look at the video again or for the first time - it does not get any better.Just a matter of time before a deal and up the share price will go.

Ridinilazole: Preserving the microbiome to reduce CD

[luminoso] 21/6/2016 12:23

Always invites sales if MMs mark it up sharp on news from the beginning. mind you, not a lot of sells to justify the fall, and then a big buy of 20k. Don't think its got anything to do with a perceived placement. Possibly the 20k buyer wanted them at that price and was obliged.

[phowdo] 21/6/2016 10:48

Course it's tumbling, the market is expecting a placing.

[smarm] 21/6/2016 10:41

Agree, strange reaction to what appears to be good news.

S

[hugus maximus] 21/6/2016 10:40

How absolutely bizarre? The share price tumbling toward £1 in response to this result:

"over, 83% (5/6) of patients on ridinilazole had sustained clinical responses compared with 22% (2/9) on vancomycin"

This drug would have saved the lives of 5 out of 6 elderly family and friends who we know personally, and who went in for minor operations in hospitals where they picked up C Diff and died needlessly.

Why are people selling shares?

[waterloo01] 21/6/2016 09:50

The elephant is hardly hiding.

[joeblogg2] 21/6/2016 09:49

You would think with the data some sort of deal could be done. Here's hoping soon!!

[football] 21/6/2016 09:47

Have we all got tunnel vision here or just blinkered or maybe is there an elephant in the room that we just can't see?

[waterloo01] 21/6/2016 09:41

It's official. It's a damp squib! On the basis of the RNS Rid'nazole would be saving many thousands of lives, and a few hundred million in hospital costs a year in the US alone, does the market care? It seems not.

Maybe we'll hear more about the progress toward a deal in the webcast this afternoon.

[football] 21/6/2016 08:21

SUMMIT'S RIDINILAZOLE PRESERVES MICROBIOME DURING TREATMENT OF C.
DIFFICILE INFECTION


-- Microbiome-Sparing Action of Ridinilazole associated with Superiority
over Vancomycin in Sustained Clinical Response Rate


Oxford, UK, 21 June 2016 - Summit Therapeutics plc (AIM: SUMM, NASDAQ:
SMMT), the drug discovery and development company advancing therapies
for Duchenne muscular dystrophy and Clostridium difficile infection
('CDI'), announces the presentation of further clinical trial data
showing ridinilazole outperformed the standard of care, vancomycin, in
the preservation of the gut microbiome of patients during treatment for
CDI. These data were derived from the Phase 2 CoDIFy trial and presented
during ASM Microbe 2016 in Boston, MA, US


read more

[football] 21/6/2016 08:20

Summit uses more than gut instinct to prove antibiotic is better than gold standard treatment

08:08 21 Jun 2016
The ongoing phase II CoDIFy trial of ridinilazole has indicated it is more effective at preserving gut microbiome of patients than the go-to drug vancomycin.

Summit Therapeutics PLC’s (LON:SUMM, NASDAQ:SMMT) new antibiotic for Clostridium difficile infection (CDI) has been shown to have further major benefits over the gold-standard treatment.

The ongoing phase II CoDIFy trial of ridinilazole has indicated it is more effective at preserving gut microbiome of patients than the go-to drug vancomycin.

This is important as disruption of the gut microbiome may explain why the infection recurs or some patients don’t have a sustained response to the drugs.

Ridinilazole, which could be used as a broad treatment for CDI, has already demonstrated “substantial clinical benefit over vancomycin”, including a big reduction in the recurrence of CDI.

The latest data will be presented at a conference called ASM Microbe 2016, which is being held in Boston.

Researcher Dale Gerding, who is Professor of Medicine at Loyola University, Chicago, said: "Ridinilazole is a shining example of translational medicine, where its high selectivity in the lab has read through to a preserved microbiome in trial patients, ultimately resulting in significantly more sustained clinical responses in a phase II trial compared to the standard of care.

"These and additional supporting data presented at ASM Microbe show the broad potential of ridinilazole as a novel treatment for CDI, and I look forward to its continued clinical development."

.uk/companies/news/127332

[waterloo01] 20/6/2016 18:21

This bit from the below is significant. "Notably, among patients aged 75 and over, 83% (5/6) of patients on ridinilazole had sustained clinical responses compared with 22% (2/9) on vancomycin"


SUMMIT’S RIDINILAZOLE PRESERVES MICROBIOME DURING TREATMENT OF C. DIFFICILE INFECTION
· Microbiome-Sparing Action of Ridinilazole associated with Superiority over Vancomycin in Sustained Clinical Response Rate

Oxford, UK, 20 June 2016 – Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces the presentation of further clinical trial data showing ridinilazole outperformed the standard of care, vancomycin, in the preservation of the gut microbiome of patients during treatment for CDI. These data were derived from the Phase 2 CoDIFy trial and are being presented today during ASM Microbe 2016 in Boston, MA, US.
Ridinilazole is part of a novel structural class of antibiotics with potential for broad use in the treatment of CDI. As previously reported, in a Phase 2 clinical trial called CoDIFy, ridinilazole demonstrated substantial clinical benefit over vancomycin, including a large numerical reduction in recurrent disease. Recurrence of CDI, and consequent failure to achieve a sustained response after treatment, is a major issue in the management of the condition and is promoted by disruption of the gut microbiome, which occurs with current mainstay treatments such as vancomycin.
“Ridinilazole is a shining example of translational medicine, where its high selectivity in the lab has read through to a preserved microbiome in trial patients, ultimately resulting in significantly more sustained clinical responses in a Phase 2 trial compared to the standard of care,” said Dale Gerding, MD, Research Physician, Hines Veterans Affairs Hospital, Professor of Medicine, Loyola University Stritch School of Medicine. “These and additional supporting data presented at ASM Microbe show the broad potential of ridinilazole as a novel treatment for CDI, and I look forward to its continued clinical development.”
In the presentation entitled “Ridinilazole Preserves Major Components of the Intestinal Microbiota During Treatment of Clostridium difficile Infection,” stool samples were obtained from 82 patients enrolled in the CoDIFy Phase 2 trial evaluating the efficacy of ridinilazole compared to vancomycin. These samples were analysed on study entry, days five and ten of treatment, days 25 and 40 post-entry as well as at the time of any recurrence for five specific bacterial groups associated with a healthy gut microbiome (Bacteroides, Prevotella, Enterbactericeae, C. coccoides and C. leptum) and also for total bacteria present. Treatment with vancomycin resulted in a significant decrease (p<0.001) in four of the five bacterial groups (Bacteroides, Prevotella, C. coccoides and C. leptum) at days five and ten, and also resulted in a significant decrease in total bacteria. In contrast, treatment with ridinilazole did not significantly decrease these specific bacterial groups nor the total bacteria. These data suggest ridinilazole may have advantages compared to vancomycin in preserving a healthy gut microbiome during treatment for CDI.
A new analysis from the CoDIFy study evaluating rates of sustained clinical response in prospectively defined subgroups of patients at high risk for recurrence is also being presented at the meeting. Consistent with findings from the entire modified intent-to-treat patient population, where ridinilazole achieved statistical superiority over vancomycin in sustained clinical responses (66.7% vs 42.4%), there were trends favouring ridinilazole in most of these groups, including older patients, those with severe disease and those with previous CDI episodes. Notably, among patients aged 75 and over, 83% (5/6) of patients on ridinilazole had sustained clinical responses compared with 22% (2/9) on vancomycin.
Other posters on ridinilazole presented today report biomarker findings from CoDIFy, data on susceptibility of C. difficile isolates from the trial to antimicrobial agents, and in vitro studies of resistance development.

[waterloo01] 20/6/2016 16:21

All 4 poster conclusions.

Conclusions: RDZ has been shown in an RCT to be highly effective at reducing recurrent CDI which is likely due to its microbiome sparing characteristics. Further clinical development in Phase 3 studies is warranted.

Conclusions: These data indicate that RDZ therapy is associated with more pronounced reductions in key markers of intestinal inflammation for subjects with severe CDI when compared to subjects receiving VAN.

Conclusions: Very few spontaneous mutants were selected in the presence of RDZ, and confirmatory susceptibility testing with mutants revealed a 4-fold increase in the RDZ MIC for a few of the C. difficile ATCC 700057 spontaneous mutants only. No resistance development occurred for RDZ after 15 serial passages with 2 C. difficile isolates.

Conclusions: Ridinilazole was active against C. difficile isolates from CDAD patients enrolled in this clinical trial. Recurrence was not associated with a change in susceptibility. A relatively small proportion of isolates in this trial were ribotype 027.