Immupharma Share Discussion Threads

[englishlongbow] 02/12/2017 17:20

IMM are anticipating market launch of Lupuzor in 2018. Lupus is a slow death sentence to many people and if Lupuzor is safer, more efficacious and cheaper than Benlysta, it will be approved.

[supernumerary] 02/12/2017 17:19

While on the subject of accelerated approval... As I've already noted, I think it unlikely that IMM will have grounds for AA, but the area is in flux. Gottlieb has just proposed extending AA so that as well as the current 'surrogate endpoint only' criterion, it could also be used where a survival benefit has been shown.

I don't see that as helping IMM either (although it could be very valuable to eg SCLP), as the current Ph3 is I think underpowered to show survival benefit, but who knows? I imagine big pharma is pressing to open up AA to all sorts of other justifications.

[hamhamham1] 02/12/2017 16:38

I find IMMs method to solving the problem very clever and looks like a naturally evolving approach. That's from a laymen's point of view anyway.

[l0ngterm] 02/12/2017 16:35

Sorry link to definition, but note my point above on accelerated approval is speculation only.And as Waterloo states it's down to the results and then how successful those results are. Stellar then who knows, reasonable then 2nd trial before approval. https://medical-dictionary.thefreedictionary.com/p+value

[hamhamham1] 02/12/2017 16:28

1retirement. Thanks. So the percentage and P value together create the outcome. ie improve in 80% of the patients & P = 0.05 is maybe the same as improving in 40% or the patients & P = 0.025? Am sure its not that simple but there will be some sort of correlation? I think that a major factor (in my mind anyway) is the fact that it targets the T cells and block the transmission of the bad instructions down the cell hierarchical chain to the end B cells. Other current solutions I think they wipe out bad and good cells which helps but leaves patients vulnerable to infections, etc? That to me isn't really a 21st century progressive solution. Well that's what I understand in my naive reading :) I am just trying to picture in my mind the process and USPs, etc. Please bare with me (and my questions) all you established IMM following peoples.

[hamhamham1] 02/12/2017 15:24

IMM sound quite confident in the results (ie following previous outcomes) from what I can see online / interviews. So I guess a partner would get better terms if they approach IMM with a deal before the results? Its a case of how enticing the approach will be. Again online / interviews indicate that IMM have been approached by several potential suitors. Does anyone agree?

[hamhamham1] 02/12/2017 15:04

Many thanks waterloo01.

[waterloo01] 02/12/2017 14:53

ham, Benlysta had to do a further trial as they changed the way it's delivered from intravenous (hospital based) to subcutaneous (done at home) so needed a further trial.

Lupuzor is likely, as stated by the FDA, to require two phase 3 trials (the current one being the first of these).

The most likely outcome is that a second trial will be needed before any approvals, however IF the data is excellent, given it's safety profile and the unmet need and after recent comments from the FDA on being proactive in looking to approve drugs in Lupus, the company hope to get an accelerated approval based on the current trial and will do the second trial as a confirmatory one.

In my view, and given it's history, unless the results are stellar, a 2nd trial is almost certain to be needed.

Any further trial is likely be funded by any partner they bring on either now or after the 1st set of phase 3 results.

Hope that's clear.

Edit: IF the results are stellar that's the scenario some on here paint where Lupuzor becomes a very valuable property

[hamhamham1] 02/12/2017 14:52

I guess what I am trying to say - is the outcome of the phase IIb trials enough from an efficacy and safety point of view that if replicated in phase III then submission to FDA, etc would happen - ie just need to repeat phase IIb outcome levels? - This is q section of txt from the IIb - "An interim analysis including 114 patients out of the target population (136 intention-to-treat patients) demonstrated an even better efficacy according to the SLEDAI score. The latter improved in 67.6% of patients under active treatment versus 41.5% of patients under placebo at week 12 (p < 0.025) and in
84.2% versus 45.8% of patients, respectively, at week 24 (p < 0.025). From this pivotal trial, it was concluded that Lupuzor was safe and had met its primary efficacy end point in lupus patients, thus opening the way towards a phase III clinical trial
that should start soon in the USA and Western Europe." --- Sorry for all the questions - I am just trying to understand the process and standards required - hopefully its not annoying long term holders too much - all my questions, etc.

[hamhamham1] 02/12/2017 14:07

Many thanks both of you. So I guess these P values are derived from a specific probability table? Brain hurts already after trying to read that previous link pdf. I really just wanted to understand what are good and bad P value outcomes from trials - thanks for the answer and compare to rivals e.g. against Benlysta, the P values on this link seem very low, far lower than Lupuzor IIb trials? But maybe the lack of side effects offsets the P values? I notice that this link shows results for GSKs 'third successful phase III study' - So does this mean that IMM are likely to need to repeat their phase III study - or do you just repeat (with minor adjustments) until you get the right outcomes in any one study? So IMM could need to repeat several times more? - hxxps://us.gsk.com/en-us/media/press-releases/2015/gsk-announces-positive-results-from-phase-iii-bliss-sc-study-of-benlysta-belimumab-administered-subcutaneously-in-patients-with-systemic-lupus-erythematosus/

[quant_investor] 02/12/2017 13:41

P is effectively the probablity that the difference observed is due to natural (random) variation rather than being attributable to the actual treatment applied.

[jpleight] 02/12/2017 13:28

ham, results are considered statistically significant when p is below 0.05. A value of 0.18 is not significant. Go to pubmed and find some random biotech publications and read how they present their result , you can learn more that way.

[hamhamham1] 02/12/2017 12:14

I read this and just wanted to understand the results comparatively. hxxp://www.immupharma.co.uk/wp-content/uploads/2015/03/Schall-Muller-Lupus-2015.pdf

[hamhamham1] 02/12/2017 11:59

L0, W1, et al. I have been looking at results from previous trials and am having problems understanding the relative scale of some of the results. What kind of percentage responses are considered high or low? And what does the 'P = 0.0xx' figure mean in brackets - plus what is a high or low score here also? - See this text - "In this population, 53% in group 1 (P = 0.048 versus placebo), 45% in group 2 (P = 0.18 versus placebo), and 36% in the placebo group achieved an SRI response at week 12. Slightly more impressive results were obtained from a target ITT group of 136 patients with clinical SLEDAI scores of 6 or greater at baseline. Among these patients, 62% in group 1 (P = 0.016), 48% in group 2 (P = 0.18), and 39% in the placebo group achieved an SRI response at week 12."

[l0ngterm] 01/12/2017 21:22

Big plonkers

[qazwsxedc69] 01/12/2017 21:20

There's a new clown in town....

[cammy5] 01/12/2017 21:08

Goodnight ,bunch of plonkers