Immupharma Share Discussion Threads

[nobbygnome] 10/2/2021 07:53

>> colsmith

You say the CNRS will have the information on the PK but that is wrong. No-one has been able to measure it in blood previously because the level is so low. However, assay methods have improved and become more sensitive so I am sure it is possible now.

The real question is how on earth does the drug work when the level is so low.....

[colsmith] 09/2/2021 13:23

Its all smoke and mirrors to me but the text seems to say that the actual PK activity is part of the P3 trial but it is the methodology that needs to be approved at the meeting as part of the overall trial structure. Maybe of note, or maybe not, both IMM and Avion seem pleased with the FDA response and are confident in progress even though the meeting is back to Q2 - again delay! I would have thought CNRS have the info on PK.

EXTRACTS

"A final guidance meeting between Avion and the FDA is being planned at which Avion will submit the methodology for assessing PK as part of the Phase 3 trial. This meeting, which is expected to take place in Q2, will also confirm previous submissions to FDA on the study design, clinical end points and approval process.

Art Deas, Chief Executive Officer, Avion Pharmaceuticals added: "Following continued positive dialogue with the FDA and with an agreed clinical and regulatory pathway over the next period, we look forward to moving Lupuzor(TM) ahead later this year."

[bendaddy] 09/2/2021 12:21

So Nobby are you predicting failure to develop an assay that ‘confirms̵7; PK activity (or most likely not) will mean they get told at the next meeting that the P3 trial proper can’t start? It doesn’t actually say that a successful assay is a prerequisite to a another P3 trial but is it in fact??

[ascov] 09/2/2021 11:32

Not sand, just realism based upon the information we have. Not speculation, No predicting either.

[nobbygnome] 09/2/2021 11:13

You carry on putting your head in the sand Ascov. The reality is there is a whole bunting of red flags fluttering in the breeze after this announcement. I predict that the phase III won't start in the second quarter.....and maybe never!

Just IMHO of course....

[ascov] 09/2/2021 11:07

All they have said is :

'Immupharma noted a US Food & Drug Administration special protocol assessment will not be applicable and a conditional approval of Lupuzor, "has not been confirmed at this time". An FDA special protocol assessment refers to when a trial's clinical endpoints and design are approved. Immupharma adds it is on track to begin the phase 3 study in the second half of 2021.'

So the FDA say, 'no early approval, you must go for a phase 3 study'. So disappointing, but not a massive surprise which is probably why the price is down a bit, not a lot.

...the rest is speculation about stuff we simply do not know.

If it's such a dodo as some would have you believe...why are they bothering ?

[nobbygnome] 09/2/2021 09:36

>> joeblogg

Don’t forget they got a phase III ready drug (in theory at least) for no upfront payment. That is unheard of! Yes they have to pay for the phase III but of course so far they won’t have spent much.

[colsmith] 09/2/2021 09:32

Maybe the company should look to the economic factory of the world - China. And do a deal or sell the lot, clearly the US are for whatever reason delaying. Interestingly it seems to work for some people and has been tested for years, now we have Covid products that seemingly have only been about less that year all approved. Sure is a crazy world; but for the company it needs to thinks a different route or maybe give up.

PS - most western companies are falling over themselves to get a chunk of China market even TESLA, so what special about the Pharma industry?

[red army] 09/2/2021 09:11

It continues to be jam tomorrow and RNS about a yet to be arranged meeting says it all. No longer have any confidence in this company or BOD.

[joeblogg2] 09/2/2021 08:57

Nobby so why is Avion behind Lupazor ?

[nobbygnome] 09/2/2021 08:33

>> bendaddy

A good question and one I don't really have an answer for. I did hear a rumour that there was some injection issues and that it precipitated at the higher dose but I must stress I don't know if that is true. Anyway for me more frequent dosing is the answer so 200 ug twice a week would be more appropriate. However, that would require going back and redoing a phase II so is no longer a viable option. The bottom line is that the clinical trial program has been appallingly managed IMHO and Lupuzor will never make it to market.

It will be a long slow death though.....

[flavio_monteiro] 09/2/2021 08:27

bendaddy...They have already tried 1000ug in a P2

[ken chung] 09/2/2021 08:19

Lemmings and mushrooms only.

[ken chung] 09/2/2021 08:18

What a dog.Lemmings and mushrooms only.

[bendaddy] 09/2/2021 08:15

Nobby. You’ve been saying this all along about dosing, half-life and site of any pharmacological activity (skin?). The P1 study dosed 200ug and 1000ug. Have you seen the readout from that to understand why they didn’t go forward with 1000ug? Safety concerns perhaps?

[flavio_monteiro] 09/2/2021 07:31

Thank You Nobby! that's what you have been saying for years.

[nobbygnome] 09/2/2021 07:29

So I guess the real question is how on earth does the drug work when there is nothing present for 27 of the 28 day dosing cycle and drug never reaches a high enough level systemically to produce the effects they showed in experiments. That has been my question throughout....

[nobbygnome] 09/2/2021 07:27

As I said earlier it seems the FDA want Avion to develop an assay to measure Lupuzor in blood to monitor the pharmacokinetics. Only 200 ug is given sc once every 28 days of a molecule which has a very short half-life so there is never much in the blood; previously they haven't had an assay sensitive enough to measure it. Clearly there will be no drug present after the first day of the 28 day dose period so I can't really see the point of monitoring the PK. It suggests to me that the FDA have concerns about the dosing level!

[flavio_monteiro] 09/2/2021 07:18

Nobby

You are a Pharma man..can you explain this?

In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic ("PK") characterizations of Lupuzor(TM), prior to commencement of the Phase 3 trial

Thanks in advance!

[nobbygnome] 09/2/2021 07:16

>> FM

You are correct that there are more questions than answers raised by that RNS. Why has the SPA been taken away? Why are they having to assess the PK?

[nobbygnome] 09/2/2021 07:11

So there are some clinical pharmacology and PK issues. That is very interesting as they have never been able to measure the peptide in blood. So if they establish a sensitive assay to measure the PK it will show that it all disappears in a number of hours. I really can't see the point of that but it suggests the FD have a concern about dose levels and drug levels.

Hmmmm who has been talking about that for years.....

[waterloo01] 09/2/2021 07:08

Lol in IMM terms it's great news, for anyone else......