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bluetigeruk and wondergoals
Thanks for your respective posts.
I have tried to put the results in layman's terms because that's what I am , a well researched layman who applies logic and common sense to what I read. I have extrapolated the results of the IBS C/D findings across to the single groups because my understanding is that the central probelm was one of numbers. Indeed the IBS C/D conclusion is based upon adding the two groups together (76 + 94 = 170) so I don't believe it's unreasonable as an exercise to calculate that increased numbers, as will be the case in the Phase 3 study, would produce similar results.
This is surely covered in the Company's response to Michael's question 3:
"(iii) We are very pleased to have achieved statistical significance in the combined group as we see Blautix as a treatment for both IBS subtypes. However, again, this was a signal finding Phase II intended to demonstrate a meaningful signal of clinical efficacy, rather than a pivotal Phase III trial which hinges on statistical significance. As you note, the statistical significance in the separate cohorts is in part a product of sample size – the ‘combined group’ are the same patients from the C and D cohorts, so the responses are the same, the larger sample size simply allows the statistical analysis to achieve significance."

I notice in one of your previous posts you questioned whether this result could cast doubt on the rest of the 4D progamme:
"The question is if this is the effect in IBS is there a similar weak or none effect in other areas?"

Somewhat surprising when Merck were looking for a 10% response rate for MRx0518 in combination with Keytruda and it achieved an unequivocal "remarkable" 42% success. Oil and Gas exploration companies may from time to time be able to pull the wool over the eyes of the sector but I don't believe that's the case in the Pharma space where everything is subject to intensive peer review, including potential partners not only for IBS but other therapies.
So much so that the Company was happy the present the results, which they were "delighted with" to a group of analysts via the webinar, the very morning of the IBS rns .
You say that the results were poor and the Company tells us that they achieved their goals and results were in line or better than products currently in the market place. This is supported by their response to Michael's question 4:
(iv) The Phase II results are a key milestone and catalyst for commercialisation efforts, supporting both progression to Phase III and our partnering conversations.

An excellent response from the Company, generated by your thoughtful questions, sent about a week ago, if I re call correctly.
As many of us have been at pains to point out, the market interpretation of the results was a mis understanding of the numbers. Had the IBS C and IBS D individual cohorts been of greater patient numbers the "not statistically significant" label would have lost the "not" and the market reaction would have been completely different.
Just to prove the point, the summary of all the results, including the example given by 4D to you, is as follows:
IBS C/D combined response rate of Blautix 24.1% vs 17.5% for placebo, so Blautix 37% better efficacy.
IBC C response rate of Blautix 25% vs 17.1% for placebo, so Blautix 46% better efficacy.
IBC D response rate of Blautix 23.4% vs 17.8% for placebo, so Blautix 31% better efficacy.
A largely scientific rns went over the heads of the pi's but those that understood have dropped anchor judging by the absence of TR1's and of course one large shareholder adding 10%.
I would expect to see a presentation appearing on the 4D website very shortly addressing matters in laymen's terms.
Final food for thought, as I posted previously, the Seres C Diff Phase 3 trial showed a statistically significant response rate of 30.2% over placebo and it was "satistically significant" because they had the numbers. Dr Stevenson has already stated in the webinar that 4D would design the Blautix Phase 3 trial with 200 patients in each of the three cohorts.

Ironhide
Agree with most of that except historically this is stronger in the afternoons, although granted not since last week.

rossanan
The posters in November are forums for the Company to tell the scientific community about the success of MRx0518.
The MRx0518 keytruda trial started enrolling for part B in June so we might get news of that but the attendees will certainly get the finer details of the 42% success rate of the part A trial.
The other biggie is the fact that the Company is releasing the detail of the MRx0518 trial as a monotherapy in solid tumours.
Any new information will need to be released to market before the conference. The monotherapy news will definitely be new.

I wouldn't want to be short on thse after that news.

Trendz
Geting his own back perhaps - taking the gloves off.
The first part of the monotherapy trial for solid tumours with 20 patients participating was open label with the second part involving a further 100 patients was the randomised double blind phase. No comment :)

In talking about oncology at around 9 mins 20 secs in:
"We are right at the forefront of making checkpoint inhibitors potentially more effective but also 0518 WORKS AS A MONOTHERAPY AS WELL.
Apologies for the capitals but I couldn't work out how to type in bold.

There's a gap higher up the tree to fill aswell.
News can land at any time and those that watch this closely will know that strangely Wednesday is historically the day when the share prices moves sharply higher or lower.

Digital
At this stage of the game it isn't about having product to sell, it's partnerships and collaborations. I suppose the only exception would be fast track clearance on MRx4DP0004 for CV19, the trial results of which we could hear anytime soon.
An example are the deals they have done on MRx0518 in the oncology space. and vaccines with Merck.
The vaccines deal for instance is worth over $1 billion in successful stage payments. Theoretically, as the deal is just over a year old, one of those could land at anytime. The part B study, withn greater patient numbers for MRx0518 in combination with the Merck drug Keytruda, has been running since June. If the success rate is similar in part B to part A, I believe Merck will move to secure the therapy before someone else with a type 1 inhibitor comes on the scene.
They are of course already talking to companies in the IBS space about Blautix.

digitalman
3 months ago when the interims were published they had £10 million cash.
They raised a further £7 million in July.

13th monkey
Yes in short it boiled down to the trial numbers.
The combined C and D had 170 participants, which was statistically significant.
The C alone had 76 participants and the D had 94, both of which were not statistically significant BUT the results were virtually the same across the three groups.
Dr Stevenson stated that for the Phase 3 trial they would design it to have 200 patients in each cohort.

In a nutshell we had a successful Blautix Phase 2 result and the market was spooked by one phrase "not statistically significant."
I been doing some research and folk might find this of interest. The phrase above and the "p value" have been courting controversy among the scientific community for a long time.
https://www.nature.com/articles/d41586-019-00857-9

eddie666
I don't understand the technical side either but I am in total agreement with the comments of Krusty.
So many people do trade on charts and technicals that they can determine the trend but fundamentals and news will always win the day for mid to long term investors and even short term traders are often caught out by unexpected news but hey that's the game we all play.
If one re reads the Proactive presentation a few times, the fact that it was a good result sinks in and will do so to the general investment community in due course. The danger for those shorting the share is that the Company's supportive shareholders will have been briefed on the reults, which are now public domain, so no rules broken and they will presumably move when the timing suits them.

Ophidain
Thanks for the reply.
I don't know if you ever saw an earlier Proactive interview when DP was asked a question about what product in the portfolio really excited the team. He replied it used to be Asthma but now everyone has swung over to the oncology therapies. It's still early days but Merck do not collaborate with small cap Pharmas, without good reason.
atb

Ophidian
As you are well aware 99% of the people inhabiting these boards have little or no experience in scientific or medical matters, certainly at this level. That's why the input of someone such as yourself, who can cross the bridge of the scientific community, to make sense of the "language" and connect with the general investment community is so useful. I for one thank you for your input.
Playing devil's advocate a bit, I was drawn to this in one of your posts " Extrapolating ANY IBS result across sexes ethnicities or ages is stupid and bad science and doomed to failure with this condition - trying to do it BETWEEN IBS C/D/M is folly. Again DYOR." During the webcast questions and answer session Dr Stevenson actually stated that they were "looking at sub populations, once all the data has been analysed." Does this concern you, based upon your comment.
I don't believe any sensible person is under the illusion that these are earth shattering results but they do show enough promise for 4D to design a Phase 3 trial. I believe we are talking in the region of £10 million plus for such a study and as I posted the other day, I'd have thought that given the top line results, the fact that Blautix treats the disease rather than the symptoms and doesn't have safety issues, then surely the big players in this space, such as Bausch and Abbvie, would show an interest.
Moving on to a trial that was more positive, albeit with a small patient population, how do you interpret the MRx0518 Keytruda studies in part A of the trial ? In your opinion is the Company's description of "remarkable" appropriate.

I've only read your post quickly but it appears you are mixing Oncology with IBS.

donotpanic
Orphidian mentioned the 80p gap in the context of the downward velicty of the share price. I know quite a few respected posters who have mentioned it and many of them do not believe it will get filled as it's a breakaway.
I haven't a clue because sadly I'm not too bright on technicals.
I believe an apology to Orphidian would clear the air and we can all move forward . To my mind there's been a misunderstanding because he feels that he has been included with the posse of de rampers. Nothing could be further from the truth.

For me the most relevant slide and accompanying information in today's webinar is on P10, the comparitive performance of Blautix against competitors at Phase 1 and Phase 2 trials.

https://www.4dpharmaplc.com/application/files/7216/0201/7566/4D_pharma_-_Blautix_BHT-II-002_Ph2_IBS_Results_Oct_2020.pdf

You will see that in the study for IBS - D, Blautix is comfortably best in class.
In the comparitive for IBS - C only Lubiprostone is the equal of Blautix and as 4D have been at pains to point out there is no therapy to treat both types of IBS, so Blautix is the stand out performer in this category.
The drugs featured in the trials on the slide have all progressed to market and are:

Rifaximia (Xifaxan) owned by Salix who are part of Bausch
Eluxadoline (Viberzi,Truberzi) owned by Allergan, a sub of Abbvie
Lubiprostone (Amitiza) owned by Mallinckrodt
Tenapanor (Ibsrela) owned by Ardelyx
Plecanatide (Trulance) recently bought from Synergy Pharma by Bausch.

So this gives us a snap shot of the people who 4D are presumably talking to, following on from the results, viewed by the Company as a big success. Let's hope that some of their peer group are of the same opinion. My own view is that given the unmet needs for the IBS patient group, to progress this to Phase 3 for the likes of Abbvie or Bausch would be absolute peanuts and would also open up channels into the MicroRx platform and other 4D therapies.

https://www.youtube.com/watch?v=C4qF9j1zjIg

Thanks Nelson :)