Summit Therapeutics Share Discussion Threads

[sorrento06] 16/8/2016 00:34

C-Diff will be announced shortly, no reason to worry. Time taken reflects the multiple deals they are negotiating. Summ have stated they prefer a multi distribution model to benefit from better distribution models in different countries. I think we could be looking at worse October to finalise deals. This leaves enough times for cash burn. Dyor, hold tight peeps. GLA!

[theunluckyone] 12/8/2016 11:26

Interesting buying this morning albeit comparatively small volumes but I wonder just how many shares the MM on the offer has available at around the £1.05 level ?
And will there be a continuation of the rebound on our share price seen yesterday on Wall Street ?

[chrisatrdg] 11/8/2016 19:10

Not exactly 'Breaking News' however some of the slides were interesting adding another layer but the presentation,I do not think, will move the share price

For now it is all on C-Diff.

[waterloo01] 11/8/2016 19:00

Erik is so droll! Given where we are I would have expected some more on market size and opportunity especially with Rid'nazole. These are financial folk, give them numbers. Wet the appetite. Sales 101.

[chrisatrdg] 11/8/2016 17:31

Per Free-Money this evening from the other board:

RE: presentation later today

Here's the slides :



Edit: Connected ?

[hugus maximus] 11/8/2016 15:01

"Sarepta has competition waiting at the gate" ... their frustration over FDA delays is leaving them behind (even if at best they only had a potential fix for 13% of the boys compared to Summit's 100%) I must admit that the handling of the FDA problems has been executed in the most bizarre way ....



EDIT - I still wonder if they (eventually) lose FDA support, it might bring a large number of shareholders here?

[waterloo01] 10/8/2016 15:47

Worth noting is a steroid not a treatment of the disease. Been around and used for ages.

[luminoso] 09/8/2016 21:46

This is undoubtedly good news. However certain nervous investors, particularly in the U.S may just be seeing increased costs and risk of dilution ahead. A case of good news being the new bad news ?
A bit like poor economic data being welcomed by markets, who see QE and low interest rates as a boost for stocks !
Bring on that C.Diff deal and then we can see good news for what it is again.

[football] 09/8/2016 17:37

Summit to include new DMD formulation in PhaseOut trial
Share
14:08 09 Aug 2016
The new formulation, F6, achieved better than a six-fold increase in the maximum plasma levels in the Phase I trial patients
picture of DNA
DMD is a genetic disease that affects boys and young men
Summit Therapeutics (LON:SUMM NASDAQ:SMMT) is to include a reformulated version of its Duchenne muscular dystrophy treatment ezutromid in the phase II trial currently underway after good safety study results.

The new formulation, F6, achieved more than a six-fold increase in the maximum plasma levels in the Phase I trial patients on two-fifths of the existing dose, said Summit.

As a result, F6 will now be a part of the phase II trial of ezutromid, PhaseOutDMD, where the first patients were dosed recently.

DMD is a fatal disease that affects boys and young men and is caused by genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles.

Ezutromid is a utrophin modulator and acts as a potential disease-modifying treatment for all patients regardless of their underlying dystrophin gene mutation.

Ralf Rosskamp, Summit’s chief medical officer, said: "The rigorous development of ezutromid has identified this new F6 formulation that achieved higher ezutromid plasma levels in patients in this trial allowing us to further explore the therapeutic effect of this promising treatment."

He added that inclusion in the PhaseOut DMD trial will also allow the company directly to compare the safety and efficacy of the F6 and F3 formulations of ezutromid and help determine which to use in future clinical trials.

"Utrophin modulation focuses on maintaining expression of utrophin protein to protect muscle health and function and we believe these two formulations of ezutromid are capable of achieving this.”


.uk/companies/news/129163

[waterloo01] 09/8/2016 15:43

Edit: Rolling the trials into one open label trial is smart. We will continue to see data after 12/18/24 weeks, which means the excitement will build IF it starts to show evidence of working. It also means no delay to the all important phase 2 placebo trial in 2nd H 17. Clearly they hope to get approval based on a robust trial post SRPT et al, but unlike many trials, the open label part will already have given us a clear view that it works (if it doesn't then they don't go ahead with the placebo trial in the first place).

Also means, reading between the above lines, that any funding just needs to get them to the end of 2017, as if the open label trial shows it works, then raising the funds mid 2016 to fund the placebo trial should be much much easier (as was the original plan to get open label results before deciding on funding but trial was late starting).

If say they need $25m to get there, then any Rid'nazole deal North of that, but keeping a decent milestone/royalty, would do the trick, although anything short of $50m as an upfront would be disappointing.




Below are some questions that you might have about this announcement provided by Summit, as well as the press release.
FAQs
1. What is different about this new formulation? Is it still taken orally?
The new F6 formulation of ezutromid uses different technology that helps it to be better absorbed as shown in this Phase 1 clinical trial. At the core, it is still the same drug candidate as the current F3 formulation, and it is still taken orally.

2. Does the new formulation still require a balanced diet and a small glass of full fat milk?
The results from this F6 formulation clinical trial were from patients who followed specific dietary guidance providing for a balanced proportion of fats, proteins and carbohydrates and who took the F6 formulation with a small glass of full fat milk.

3. Is the F6 formulation going to be used in the PhaseOut DMD trial?
We expect that up to ten boys in PhaseOut DMD will receive the F6 formulation of ezutromid, subject to regulatory approval. We are now enrolling up to 30 patients on the F3 formulation.

4. Why aren’t all boys in PhaseOut DMD receiving the F6 formulation?
We believe utrophin modulation will be possible with both the F3 and F6 formulations. The new F6 formulation allows us to study the effect of higher concentrations of ezutromid and evaluate how its safety and efficacy compare with the F3 formulation over the 48 weeks of dosing. We expect the F6 formulation will only be available in the US at a limited number of sites, subject to regulatory approval. We expect the results from PhaseOut DMD to inform which formulation of ezutromid we use in future trials.

5. Is the F6 formulation safe?
The F6 formulation of ezutromid was generally well-tolerated at the doses tested. One patient had changes in liver parameters in laboratory findings; he showed no clinical symptoms but was withdrawn from the trial as a precaution and the finding was classed as a serious adverse event. The enzyme levels returned to normal soon after ezutromid dosing was stopped.

6. Will my son have a better chance of seeing benefit if he’s on the F6 formulation?
We don’t yet know if either the F3 or F6 formulation of ezutromid will produce a clinical benefit in patients with DMD, which is why we are testing both in the PhaseOut DMD clinical trial. The key to beneficial effects of utrophin modulation in animal models of DMD is sustained utrophin production and not necessarily the level of utrophin. We believe both formulations will be able to sustain utrophin production in patients.

7. How will you choose which boys get the F6 formulation?
If the protocol amendment to include the F6 formulation in PhaseOut DMD is approved by the regulatory authorities, we expect to enroll up to ten patients on the F6 formulation. This is likely to occur after 30 patients are enrolled on the F3 formulation, and the assignment of the boys to the F6 formulation will be based on the revised protocol.

8. If the trial is extended, which formulation will the boys receive?
This decision will be based on the data gathered from PhaseOut DMD.

9. If my son is already enrolled in the trial, can I ask for him to go on the F6 formulation?
No, patients who are already receiving ezutromid will continue to get the formulation with which they started. The incorporation of the F6 formulation into the PhaseOut DMD trial will be based on the revised trial protocol, once the amendment is approved by the regulators, and not family/patient/physician choice.

[luminoso] 09/8/2016 12:26

I was wondering,joe. Thanks for re-assurance !

[joe shone] 09/8/2016 12:25

that 60.000 can't be a sell as it is not delayed.probably a worked buy gl,joe

[chrisatrdg] 09/8/2016 12:22

RNS

This is great news being able to incorporate the new formulation into current trials.In addition we now have a clear timetable through to 2019 when they hope to get regulatory approval.Game,set & match.Hopefully the markets will appreciate the significance of this update.

[waterloo01] 09/8/2016 12:18

Excellent increase in uptake, although one adverse event in raised liver 'parameters'. To be incorporated into current phase 2 which is back on plan. Placebo trials to start 2nd half 2017 with potential filing 2019.

All good.

[football] 09/8/2016 12:05

SUMMIT REPORTS POSITIVE PHASE 1 NEW FORMULATION DATA AND OUTLINES ROUTE
TO MARKET STRATEGY FOR DMD CANDIDATE EZUTROMID


-- New formulation of ezutromid achieved over a six-fold increase in maximum
plasma levels in patients

-- Plans include incorporating new formulation into PhaseOut DMD trial


Oxford, UK, 9 August 2016 - Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM), the drug discovery and development company advancing therapies
for Duchenne muscular dystrophy ('DMD') and Clostridium difficile
infection, today reports Phase 1 clinical trial results that show a new
formulation of ezutromid (referred to as 'F6') achieved a greater than
six-fold increase in maximum plasma levels in DMD patients compared to
those achieved with the current clinical formulation (referred to as
'F3') with only two fifths of the dose.

Following these positive data, Summit also outlines its development
strategy through to applications for market approval for ezutromid, a
utrophin modulator. Utrophin modulation is a potential disease modifying
treatment for all patients with this fatal muscle wasting disease,
regardless of their underlying dystrophin gene mutation.

"The rigorous development of ezutromid has identified this new F6
formulation that achieved higher ezutromid plasma levels in patients in
this trial allowing us to further explore the therapeutic effect of this
promising treatment," commented Dr Ralf Rosskamp, Chief Medical Officer
of Summit. "Following these encouraging Phase 1 data, we plan to
incorporate the F6 formulation of ezutromid into our ongoing Phase 2
trial, PhaseOut DMD. This will allow us to directly compare the safety
and efficacy of the F6 and F3 formulations of ezutromid, and help
determine which to use in future clinical trials.

"Utrophin modulation focusses on maintaining expression of utrophin
protein to protect muscle health and function and we believe these two
formulations of ezutromid are capable of achieving this. It is therefore
appropriate to now outline our clinical pathway to seek marketing
approval of ezutromid."

[solomon] 08/8/2016 22:09

Hmm 28% share price rise for MEIP today, On Friday there was a bit of interest too. Can't stop those in the know havin' a go.
28% rise for SUMM would only take us back to the recent peak in April. We can do better.
Thanks Waterloo for your wide-ranging news and views.

[waterloo01] 08/8/2016 20:51

Good to see the three main centres in the UK all recruiting. Listing is precursor to US sites opening.



Not sure of market size of indication (subgroup) but deals are being done. Low upfront ($15m but milestones are almost 10 x market cap).

"As Helsinn executes this strategy, MEI will receive anything up to $449 million in milestones. While all the milestones bar the $5 million tied to the start of the Phase III AML trial are some way down the line, and may never materialize, the $444 million nonetheless represents sizable potential paydays for a company that had a market cap of $56 million as of the end of last week. Helsinn is also making a $5 million equity investment in MEI."

[chrisatrdg] 08/8/2016 20:42

Summit Therapeutics ‏@Summitplc 5h5 hours ago

Our PhaseOut DMD clinical trial is now listed on go 2 … 4 more info on the trial #Duchenne

3 retweets 1 like
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[chrisatrdg] 07/8/2016 11:30

per gmcc yesterday from the other board:
1)
'RE: DMD " Never say never "

July 2016 “Duchenne Muscular Dystrophy" recent Kay Davies interview !

"Prof Dame Kay Davies, Dr Lee's Professor of Anatomy at the University of Oxford"



Good luck DMD boys !'
2)
'Tackle Antimicrobial Resistance

FYI : Note WT involved in this new initiative !

“Wellcome Trust is a global charitable foundation in London, UK. They are a major funder of biomedical research with significant experience in infectious diseases and investment in early stage antibiotic R&D. In addition to providing funding, Wellcome will bring expertise in overseeing high quality international research projects; “





“Beginning in September, CARB-X will begin reviewing applications to determine the most promising products to fund. Decisions will be made by the Scientific Advisory Board, with input from the agencies, including BARDA and NIAID, and the funders. Applicants should check the website (www.carb-x.org) for updates.”

Remember : “The development of ridinilazole was supported through Phase 2 by the Wellcome Trust following the award to Summit of a prestigious Seeding Drug Discovery and a Translational Research Award.”

Not sure if ridinilazole qualifies as really a phase 3 stage candidate but maybe an outside chance / opportunity for Summit to get their drug into the selection frame for some additional funding through this new enterprise ?'

3)

'Tackle Antimicrobial Resistance

Yes always better to listen to the medical experts !

“CDI results from damage to the microbiome, and patients experience further collateral damage through the use of broad spectrum antibiotics to treat CDI, leaving them vulnerable to recurrent disease,” commented David R. Snydman, MD, FACP, FIDSA, Chief, Division of Geographic Medicine and Infectious Diseases and Hospital Epidemiologist of Tufts University School of Medicine. “New, selective antibiotics are needed to minimise these high recurrence rates, and ridinilazole demonstrates an exceptional ability to preserve a patient’s microbiome and allow the growth of protective bacteria, which are vital to protecting against CDI.”

[chrisatrdg] 05/8/2016 13:53

Next weeks conference

The 36TH ANNUAL CANACCORD GENUITY GROWTH CONFERENCE 10-11 August 2016, Boston, US per todays RNS will be an opportunity to listen to Summits CFO.

In addition there will be people in the audience attending the conference who no doubt will ask some pressing questions in addition to questions on the science progress.We may just have a better idea after the meeting which is being held at a sensitive time.

I will be listening.GLA

[hugus maximus] 04/8/2016 17:45

What's this all about Alfie? Bizarre to say the least. Surely the FDA must take badly to these sorts of accusations and I'm surprised to see a site like SeekingAlpha allowing what looks to me like something that might prompt litigation? Whatever we think of this, watching Sarapeta's dealings with the FDA has been a great education for Summit. i.e. How not to do things!

Seeking Alpha - this afternoon:-
-Sarepta Eteplirsen dystrophy testing levels.
-Definition of testing methods.
-FDA Adcom Faults and Failures and Misrepresentations.

The article starts with this:
"This is a detailed account of how the FDA lied and manipulated the public, the DMD community and the panelists during the Eteplirsen Advisory Committee (ADCOM) Meeting held earlier this year."