Summit Therapeutics Share Discussion Threads

[luminoso] 23/3/2018 12:59

Anyone else hear the sound of a band wagon wheels beginning to squeak into action ?

[kabo87] 21/3/2018 21:17

https://bzweekly.com/2018/03/21/0-81-eps-expected-for-summit-therapeutics-plc-smmt/

[luminoso] 21/3/2018 14:05

Thanks waterloo. great find.

[waterloo01] 21/3/2018 08:35

"Lower extremity qMR biomarkers have a robust relationship to clinically meaningful measures of ambulatory function in Duchenne muscular dystrophy. These results provide strong supporting evidence for qMR biomarkers and set the stage for their potential use as surrogate outcomes in clinical trials."

These are the people we worked with and is very encouraging in that it supports these measures as a surrogate end-point.

Will add to weight with FDA and is a definite plus.

[hugus maximus] 15/3/2018 17:19

A CONSPIRACY THEORY .. if this happens, you all owe me a pint at the AGM:

Is there any mileage in the possibility that Sarepta are holding back acquisition of Ezutromid as a foil for the day after the bad news is released that Exon Skipper Numero 51 loses EU approval? You can just imagine the spin they would put on Ezutromid .. "ze most vorter tight DMD drug trial ever conducted ... tomorrow ze vorld is ours!" ... and it would be.

[hugus maximus] 15/3/2018 08:55

Freedosh - many thanks for your observations ... giving us some great informed background.

Thanks Waterloo - this adds further to Sarepta's seemingly unstoppable upward trajectory!

Perhaps in terms of management politics and shareholder relations, Ezutromid (if as successful at 48 wks as we hope) could be brought into Sarepta's fold as a consequence of "synergy studies"?!

[freedosh] 14/3/2018 16:31

A semantic nicety but complimentary does not imply synergy per se. For example it may be that the drugs could be used in alternate cycles rather than given concurrently. It would be nice to know what they are looking at.

[hugus maximus] 14/3/2018 16:23

That's great news to hear things looking good for you Freedosh. Many thanks for your update.

"Synergy studies" ... also hinted at in todays RNS : "Summit also believes that utrophin modulation could be complementary to other therapeutic approaches for DMD"

Assume if EU approval isn't a pushover for eteplirsen, it would be beneficial for Sarepta to suggest a "synergy" with ezutromid ... thus making any further move that they may make on Summit's drug look like something they are acquiring as "complementary". i.e. not as commonly referred to by NASDAQ analysts as "competition".

Not withstanding ... functional stability of 6MWT and North Star Ambulatory Assessment being most crucial proof of concept for ezutromid.

Take good care sir!

[freedosh] 14/3/2018 12:43

Thanks Hugus. I'm well at present and hope to be st the AGM.
I'm hoping that the hidden message is that we and Sarepta might have done, jointly or independently, synergy studies with EZD and exon skipping. I see no reason why they might not be either additive or synergistic . I have nothing else to add at present other than to say that whilst our science appears impeccable the regulators will still want to see functional stability or improvement.
Best wishes.

[waterloo01] 14/3/2018 11:48

It's probably the closest they will come to criticism of SRPT data. Ie ours will be independent and robust.

[hugus maximus] 14/3/2018 11:41

Freedosh - hoping this finds you in improving health. I'm sure that I speak for many here when I say that we miss you're informed medical knowledge, whilst so much of what's going on in the DMD field is linked to seemingly small detail.

Incase you pop in here from time to time:

Given Sarepta's current success, one wonders if you think there's anything in EZD 24 wk data so far, that can compare to the seemingly small effect on muscle development found in Eteplirsen, which has garnered them such success?

i.e. Comparing changing Dystrophin and Utrophin levels directly is clearly no indication, so is there anything available in 24 wk data so far that may be compared to the Eteplirsen work, or did Sarepta so neatly bungle their way through the FDA, that any attempt at comparison is impossible aside from 6MWT? Perhaps there’s still further specific 24 wk data you look forward to seeing, which may help point to EZD outcome before 48 wk report?

All my very best to you,
HM

[hugus maximus] 14/3/2018 11:09

RNS Excellent summary of muscle biopsy and good description of work undertaken ... but specific pointing out that the presentation to the FDA will be absolutely unquestionable due to the forensic nature of tests ... so one might assume that a successful 48 wk data result will be followed by request to FDA for early approval?

Mention again of "utrophin modulation could be complementary to other therapeutic approaches for DMD"

EDIT In the light of new data for Exon 53 skipping drug by Sarepta being presented as "it's better than Exon 51 skipper - so it must get FDA fast approval" ... one sees todays RNS as an important reminder of empirical data being gathered by Summit ... no flim flam!

[football] 14/3/2018 11:05

Summit Therapeutics plc Summit Highlights Scientific Rigour Of Its Phaseout Dmd Clinical Trial At Mda Clinical Conference
14/03/2018 11:00am
UK Regulatory (RNS & others)


TIDMSUMM


Summit Therapeutics plc

("Summit" or the "Company")

Summit Highlights Scientific Rigour of its PhaseOut DMD Clinical Trial
at MDA Clinical Conference

Oxford, UK, and Cambridge, MA, US, 14 March 2018 - Summit Therapeutics
plc (NASDAQ: SMMT, AIM: SUMM) highlighted the rigour being utilised in
the collection and analysis of muscle biopsies and magnetic resonance
spectroscopy ('MRS') related data in its PhaseOut DMD clinical trial, at
the 2018 MDA Clinical Conference in Arlington, VA.

PhaseOut DMD is a Phase 2 open-label trial of the Company's utrophin
modulator, ezutromid, in patients with Duchenne muscular dystrophy
('DMD'). Through this study, Summit is compiling a deep dataset for each
patient in the trial, which includes the analysis of several thousand
muscle fibres per biopsy sample. As part of this effort, steps are being
taken to remove human bias through the automated reading of biopsy and
MRS measurements at central sites.

"Since DMD is a muscle-wasting disorder, it is critical for us to have
high quality data from objective muscle health measurements as we assess
ezutromid's activity. As the collection of muscle biopsy and MRS
measurements are a major intervention for patients in clinical trials,
it means it is crucial this is done in a robust and reliable way," said
Dr David Roblin, Chief Medical Officer and President of R&D of Summit.
"Our data collection and analysis methods used in PhaseOut DMD helped
yield a high-quality dataset from all evaluable boys in the trial after
24-weeks of treatment. We are grateful to all the boys in the trial and
excited about the interim findings that showed compelling signs of
ezutromid activity."

The recently announced positive interim data from PhaseOut DMD showed
that after 24 weeks of treatment, there was a significant and meaningful
reduction in muscle damage, as well as a significant reduction in muscle
inflammation, in patients treated with ezutromid. These data provide
early evidence that ezutromid is modulating the production of utrophin
protein and having its intended effect of stabilising muscle membranes,
which has in turn led to early improvements in muscle health. Utrophin
is a protein that can substitute for dystrophin, the protein that is
missing in those with DMD the absence of which results in disease
progression and premature death. Because Summit's utrophin modulation
approach is independent of the patient's underlying dystrophin gene
mutation, it could be applicable to all patients with DMD.

Details of the Methodologies from the Poster Presentation

One of the methods being used to measure muscle damage in PhaseOut DMD
is biopsy analysis. Summit has made a significant effort to ensure that
these biopsies are handled, processed and analysed with great care. For
the biopsy procedure, two pieces of muscle are taken during each biopsy.
These pieces are frozen and shipped separately to a central reading
facility. Multiple sections from each biopsy are assayed for muscle
damage, yielding a total of six biopsy sections for each patient for
both the baseline and post-treatment samples. After quality control
checks, the muscle sections are then read via an automated system to
remove human bias. For the 24-week assessment, several thousand muscle
fibres were analysed per sample, producing a robust dataset for each
patient with high concordance across individual samples.

Muscle inflammation is measured by T2- relaxation time using MRS. MRS of
the soleus (calf) and vastus lateralis (thigh) muscles is performed at
central imaging centres following a training and certification process.
The MRS quantification is then performed by an automated blinded
process.

[algernon2] 13/3/2018 21:26

[...] tricky link!

[chrisatrdg] 13/3/2018 21:15

Summit Therapeutics discovers new antibiotic compounds in fight against gonorrhoea:



XX proactive XX investors

[hugus maximus] 13/3/2018 18:38

Glyn has a good relationship with Welcome, where Dame Kay is now a Governor. Surely a perfect fit ... and they were very supportive with C Diff?

As has been said by others, it just needs governments around the world to finally react to the gravity of the anti-biotics issues, whereupon they'll started allocating funds. Meanwhile Big Pharma knows this and will sit on their hands until such time. Tragic but probably prophetic.

[waterloo01] 13/3/2018 16:58

Given how well linked in they are now to grant money, be surprised if they didn't go for this 1st. wellcome? Barda? Gates? This is an area of significant and urgent interest.

They have mentioned the possibility of splitting the company, and this must make that even more likely IMO. Not impressed with SRPT approach and suspect they will end up making a bid for DMD.