Summit Therapeutics Share Discussion Threads

[chrisatrdg] 23/2/2018 21:32

At last SMMT is moving back up on the NASDAQ closing at $12.20 = £1.74 lets hope AIM follows next Monday.Enjoy the Rugby this weekend.

[hugus maximus] 22/2/2018 19:05

There's a buzz on NASDAQ BB's that Sarepta EU authority decision on Eteplirsen approval is imminent. Personally I'd be surprised if the data that got them through the FDA will secure an EU approval. (However I'm not sure what additional research to the work the FDA reviewed is in their application ... if any?) Their share price seems to have been pretty good of late.

[chrisatrdg] 21/2/2018 09:40

Click on the link above ?

[gclark] 20/2/2018 20:23

How do we join the call?

[chrisatrdg] 20/2/2018 20:06

Project Happening Tomorrow (I am away but others may be interested).

Expert Interview @ 11:00am EST

Digging Into the 24 Week PhaseOut DMD Data for Ezutromid Recently Press Released.

This call is free to JOIN due to the sponsorship by Summit.

Why Investors Should Care:

Ezutromid is a unique approach to treating DMD that potentially could be used to treat 100% of patients.
Interim Phase 2 data showed a significant reduction in muscle damage after 24 weeks of treatment with Ezutromid in addition to elevated levels of utrophin production.
An expert call to better understand the endpoints reported and significance of the increases demonstrated will give investors more confidence heading into the 48 week results later this year.

Who's the Expert?
Professor of Neurology, Medicine and Biochemistry and Director of the Senator Paul D. Wellstone Muscular Dystrophy Research Center
Key Opinion Leader in field who manages a lab of 15 scientists focused on conducting cutting edge research to develop treatments for muscular dystrophy
Author of many papers on DMD and the book "Duchenne Muscular Dystrophy: Advances in Therapeutics (Neurological Disease and Therapy)"
Join Now For Free & Add YOUR Questions!

Sponsored By: Summit Therapeutics
Summit is a clinical-stage drug discovery and development company advancing innovative therapies to significantly advance the current standard of treatment for serious unmet medical needs.

Summit's strategy focuses on two therapy areas: Duchenne muscular dystrophy, a fatal genetic muscle wasting disease, and the infectious disease caused by the bacteria C. difficile.
Want to hear directly from SMMT Management? Check out our previous call with their CEO here: LINK

[gclark] 20/2/2018 14:01

Valid points Hugus. I'm probably more focused on the fat levels, and the two unknowns are what would have they been like without the treatment ie. would they have increased further, and does it take longer than 24 weeks to achieve a turnaround in a chronic inherited disease such as DMD.
I suppose my expectations at 24 weeks were not particularly high; hoping for evidence of a turnaround at 48 weeks.
I'm still sure they must have data around for the 'placebo' group, at least on the fat measurement, that will negate the need for a placebo control arm in any Ph3 trial IF there is evidence of a high probability of some efficacy from Ezutromid.

[hugus maximus] 19/2/2018 18:28

Evening gclark ... I suspect that the continued lack of interest expressed in the share price is because there were a couple of complicated unanswered questions thrown up in the Q&A, the day of the 24 wk Results RNS. Hopefully a closer look at the data will start to produce explanations. (Not negatives but for example: some info as to what reason might there be for F3 & F6 formula throwing up the same results, when more drug absorption in F6 data might be expected to create more effect on muscle, and why the strange behaviour of fat levels?)

The delight in such good top line results being presented so quickly, hopefully gives the team a chance to take a deep breath before more work on detailed analysis starts to fill in some missing gaps. Be great to see an RNS with further info soon.

[gclark] 19/2/2018 16:28

I presume that it was felt it would be easier to recruit for the study if boys only had to have a biopsy at baseline, and then one more at either 24 or 48 weeks. I am not sure that was a sensible idea, as the more information you have, the better.
I would be asking all those on the 24 week biopsy arm if they would be willing to have a further biopsy at 48 weeks. It would not technically be within the study protocol and would require the support of the local investigators, but in my view, very sensible. The data is just asking to be collected, and otherwise it is wasted.

I do think that if there is good evidence from this trial then the FDA must make Ezutromid available as quickly as possible to meet a clear unmet need. As I said before, a placebo Phase 3 trial in such circumstances would be unethical - forcing half the boys to take a placebo rather than a drug that does/might work, and allowing the disease to progress faster than needed.

As I stress, if there is evidence ... I don't think we could have expected much more from the first 24 weeks data.

AIMHO

[hugus maximus] 19/2/2018 11:23

Thanks Waterloo ... good to see the potential for non-invasive monitoring featured here as this must be so brutal for the boys. In addition to which in the case of Summit's ongoing P2, once boys have been measured at 24 weeks, due to absolutely understandable circumstance they cannot then be measured using that technique at 48 weeks ...which must make the data available less useful without the comparison. More options are bound to be good news. (EDIT i.e. Currently the boys are measured once at either 24 wk or 48wk due to the dreadful invasive nature of biopsy)

After all the Sarepta/FDA shenanigans, these new guidelines may also make it easier for Sarapeta's next Eteplirsen FDA hurdle? (From memory their trial data should be coming through in 2019 and there are more means of FDA analysis available now.) They're still awaiting European approval (due imminently?) and one still wonders if on current data that might be refused, throwing the company into another spin.

Don't these new guidelines seem to offer faster options to prove categorically whether or not DMD treatments do actually work or are they in reality more reasons for fog?

[waterloo01] 18/2/2018 08:01

New guidance out from FDA re DMD. It does demonstrate a more flexible approach including use of novel biomarkers and some alternatives to some of the function tests



In dystrophinopathies, biomarkers that reliably reflect the health and amount of skeletal muscle
at a biochemical, cellular, or tissue level may be useful across the drug development process,
17 See the draft guidance for industry Adaptive Design Clinical Trials for Drugs and Biologics. When final, this
guidance will represent the FDA’s current thinking on this topic.
Contains Nonbinding Recommendations
11
including use as prognostic, predictive, or pharmacodynamic markers, or, in some instances if
supported by sufficient scientific evidence and acceptable analytical methods, as surrogate
endpoints to support accelerated approval. A single biomarker measure can, in different
circumstances, serve different functions; for example, baseline dystrophin expression can be a
marker of a patient’s prognosis whereas an increase in dystrophin could reflect biological
activity of a drug and guide key aspects of drug development such as dose selection and route of
administration. Even if it cannot be concluded that a given biomarker can serve as a surrogate
endpoint, positive findings based on a biomarker may help support the mechanism of action of a
drug, help identify the appropriate patient population to study or treat, or support the validity of
findings on other endpoints. To support continued progress in overall drug development for
dystrophinopathies, trials with clinically meaningful endpoints should include a selection of
relevant biomarkers to help establish the correlation between such biomarkers and clinical
endpoints.
The potential for a biomarker to predict clinical benefit in dystrophinopathies could relate to the
magnitude of change of the biomarker and tissue in which the biomarker is measured. The
meaning of a change in a biomarker might also depend on the age or disease stage of a patient or
on other patient factors such as inflammation or autoimmunity to dystrophin or other muscle
components. When biomarkers are assessed, analytical validity should be demonstrated to the
extent possible, and there should be adequate assessment of the performance characteristics of
the biomarker assay, including quality-control measures and documentation of results.
Deficiency of functional dystrophin appears to be the proximate cause of the symptomatic and
functional consequences of dystrophinopathies, justifying particular interest in dystrophin as a
biomarker and as a potential surrogate endpoint for accelerated approval.
FDA also encourages sponsors to consider the use of other biomarkers, such as those measured
with magnetic resonance imaging or magnetic resonance spectroscopy. Advantages of imaging
include its noninvasiveness, its ability to assess large samples of muscle, the fact that it can be
performed repeatedly at multiple time points, and its ability to assess multiple regions of the
body, including cardiac muscle.

[hugus maximus] 15/2/2018 15:35

I've just been doing some research as to what's responsible for positive NASDAQ move and that holding is since 2016 ... so sorry - not news.

[waterloo01] 15/2/2018 15:31

I think it just restates holding. Not changed of late.

[hugus maximus] 15/2/2018 15:04

Just spotted on NASDAQ BB ... "Steve Cohen point72 Asset now own 5% of Summit - see recent SEC filing."

Point72 is a leading Hedge Fund investor and involvement in Summit significant.

[waterloo01] 15/2/2018 11:44

Would like to attend but will be away mid July, so depends on when it's held.

[chrisatrdg] 15/2/2018 11:11

Hi All Thanks for the feed back & yes I will be at the AGM more likely with HM & a coffee would be welcome.Not sure it will be a champagne AGM but likely to be interesting.It would be good if old stalwarts like waterloo01 could attend hopefully he will not be double booked.As for Freedosh I hope his health is holding up.Regards to all.

[hugus maximus] 15/2/2018 08:38

Morning Chris.

Thanks for the reference.

So what we need is some detail from the 24 wk data that removes doubt around some difficult questions, and a stunning result at 48 wks.

GLA

[algernon2] 14/2/2018 23:07

No Chris you are right in how you read it.The implication is clear: at 48 weeks if all goes well and results are as indicated (similar) or better than the 24 weeks then maybe an accelerated approval will be granted dependent on constant monitoring and feeding back of results to keep the approval current and ongoing (straight to a phase 4 ongoing Trial?!).
Freedosh can be more elegant or eloquent in how it works than I am if he is listening.
Here's to a good year all.Hope to see you all at next AGM I fully intend to stop saying "I will attend" and actually really attend the next one. Wear a name badge Chris and i'll buy you a coffee up there if you also manage to make it.

[chrisatrdg] 14/2/2018 16:24

Slide 7



I could be wrong & maybe I am but there is talk about acceleration of DMD after phase 2 as indicated by Glyn in a previous presentation.

Edit: Am I wrong guys ?

[hugus maximus] 14/2/2018 16:00

Me too .... come on Chris?!

[waterloo01] 14/2/2018 15:56

What did I miss?

[chrisatrdg] 14/2/2018 15:53

Hi HM Just been looking myself & also noticed AIM is also on the move up.I think there is a correction taking place & currently the US stock market is up.In addition I think that reports on Summit recently are having a positive effect.Regards Chris

Edit: Have a look at this weeks presentation & see if you can see the possible Glyn give away.

[hugus maximus] 14/2/2018 15:40

Fascinating NASDAQ action today ... "answers on a postcard"?

[chrisatrdg] 13/2/2018 21:18

Summit tweet this evening:
Summit Therapeutics
@Summitplc 1h1 hour ago
More - We're looking forward to attending the @Parent_Project meeting in Rome this weekend and sharing our positive interim 24-week data from PhaseOut DMD with families! #Duchenne #utrophin

[chrisatrdg] 13/2/2018 20:44

Summit Therapeutics (SMMT) Presents At BIO CEO & Investor Conference - Slideshow



Edit: Worth a read.

[luminoso] 13/2/2018 17:22

Probably just the BTIG note with a target of 33 dollars. Posted earlier by hugus.