Immupharma Share Discussion Threads

[david gruen] 13/4/2022 07:28

Surely we have to at least 10-bag initially from here!

[stinkologist] 13/4/2022 07:26

Probably finishing his night shift at McDonalds since he also got destroyed with his position on SNG. Arrogant nob.

[sicilian_kan] 13/4/2022 07:10

Hi nobby, does this not destroy your position? Would be grateful for your views:

“ Subcutaneous injection of P140 (in both 200 microgram ("mcg") and 800 mcg doses (note: 1mcg = 1 millionth of a gram) showed a clear time and dose-related PK profile which is detectable in the blood of human volunteers and applicable for all potential clinical dosing regimens of P140”

[david gruen] 13/4/2022 07:04

Immupharma PLC

13 April 2022

RNS | 13 APRIL 2022

ImmuPharma PLC

("ImmuPharma" or the "Company")

UPDATE on P140 (LUPUZOR(TM)) clinical progress

Data confirms positive readout from P140 PK study

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to provide positive data from the Lupuzor(TM)/P140 pharmacokinetic ("PK") study, required by the US Food & Drug Administration ("FDA"), as part of the new optimised international Phase 3 trial of Lupuzor(TM) in lupus patients.

Key highlights

-- Data successfully demonstrates the PK study has met the key endpoints requested by the FDA
-- The dosing of healthy subjects commenced on 15 February 2022 following approval by the Medicines and Healthcare products Regulatory Agency ("MHRA")

-- Subcutaneous injection of P140 (in both 200 microgram ("mcg") and 800 mcg doses (note: 1mcg = 1 millionth of a gram) showed a clear time and dose-related PK profile which is detectable in the blood of human volunteers and applicable for all potential clinical dosing regimens of P140

-- The final group of subjects completed dosing on 30 March 2022. This was a group of subjects that received an intravenous injection of a 800 mcg dose of P140, which showed successful measurement of the absolute bioavailability of the drug (as a control)

-- Importantly, and in-line with all human dosing to date, P140 was safe and well tolerated across all doses and in all subjects

-- This positive PK data now clears the path for commencement of all clinical studies within the P140 platform. In addition to lupus, there is a planned Phase 2a/3 pivotal trial in chronic inflammatory demyelinating polyneuropathy ("CIDP")

-- Avion Pharmaceuticals, our US partner, has been integral to the development, initiation and successful conclusion of this PK study. Together, we are preparing next steps for the progression of the P140 clinical program and this will be communicated in due course

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:

" We are delighted to be announcing this successful readout of the PK study. This is a significant milestone for ImmuPharma and for shareholders, and recognition of the key investment thesis behind ImmuPharma, in respect to having P140 (Lupuzor(TM)), a late-stage Phase 3 clinical asset for the treatment of lupus patients with a Phase 2a/3 pivotal trial in CIDP close behind."

Dr Tim Franklin, Chief Operating Officer, added :

"The PK results are highly significant for the progress of the P140 program. The ImmuPharma Biotech team in Bordeaux also performed predictive modelling in animals that not only confirmed our confidence to detect P140 in the human PK study, but also proved, in those models, that P140 continues to work long after it disappears from the plasma. This strongly supports the unique autophagy mechanism of action shown by Prof. Sylviane Muller. We would like to extend our thanks to Prof Muller and our longstanding collaboration partner, CNRS. We look forward, to working closely with our partner, Avion, on the next steps towards the Phase 3 study of Lupuzor(TM) in lupus patients, whilst we also progress our CIDP clinical program."

[wololol] 24/3/2022 08:04

Nice buys first thing. Should see a proper breakout soon.

[lord loads of lolly] 14/3/2022 11:17

Decent buying? Are you sure? The share price is LOWER at time of writing. Possibly yet another case of sells being incorrectly flagged as buys?

[wololol] 14/3/2022 10:08

Some decent buying today. I would imagine this should increase in anticipation of positive pk results any day now.

[wololol] 13/3/2022 16:05

End of q1 they said so any day now.

[chadders] 11/3/2022 15:48

When's the PK study news due?

[lord loads of lolly] 01/3/2022 14:00

eva_1989 - 9 Feb 2022: "with Mcap of 20Million - what could go wrong?". My reply - 9 Feb 2022: "I'd say an Mcap of anything less than £20M is what could go wrong." 28 Feb 2022: Mcap now £15M (a 25% drop in less than 3 weeks - albeit with war intervening). eva_1989 - 28 Feb 2022: "Wanted to put my last tranche here but now way underwater and no news from Tim concerned me."

[wololol] 01/3/2022 08:59

News die in 3-4 weeks, think we should see a nice climb up to at least 10p beforehand

[eva_1989] 28/2/2022 22:35

Drop here is very Concerning..

Today I took huge punt in AGL. Wanted to put my last tranche here but now way underwater and no news from Tim concerned me.. expected RNS when they dosed first patient

[eva_1989] 27/2/2022 19:33

Fair enough…

[lord loads of lolly] 25/2/2022 14:31

eva_1989 - It's "If PK approved", not "once".

[eva_1989] 24/2/2022 18:41

Lord,

Ouch to me then!

But once PK approved, then IMM will fly. 3/4 more months to go and then Avion will take over P3 and expect huge rerate.

Patience.

[lord loads of lolly] 23/2/2022 10:58

My thoughts and prayers with eva_1989, following her recent (fictitious?) buys "8-Feb-22 15:30:15 6.6887 140,000 9,364. 08-Feb-22 15:22:08 6.6407 100,000 6,641."

[eva_1989] 21/2/2022 08:12

My thoughts and prayers with Nobby

SNG - ouch!

[david gruen] 17/2/2022 09:06

This looks set to rally.

[nobbygnome] 10/2/2022 19:08

>> bendaddy

Let's be clear, I don't know what the FDA will do because I don't know why they asked for the PK study and clearly I don't know exactly what the results will be. However, there is a chance that the results will be such that the FDA don't approve the phase III to proceed. But the bottom line is we just don't have enough information because as usual the company have treated the shareholders like mushrooms!

[colsmith] 10/2/2022 18:23

Unlike some companies, which have AT all day, there aren't many AT trades but there are some; interesting as to what policy is in the algo's, not sure but for sure there is something as at this price its seems a waste of time even though trading this way can make cash whether the price goes up or down! So is it to influence the price - up, down or evens?

[bendaddy] 10/2/2022 17:46

So basically Nobby you expect the FDA to reject the PK study results, not allow the new P3, micky-mouse Avion to run a mile and Tiny-Tim will re-start the 7-8yr cycle all over again with a P140 dosing study and trials with the new second generation 'improved' version - we'd better hope some other miracle CNRS peptide comes through in a different therapeutic area ..... or it's all over for us long suffering LTH's.

[waterloo01] 10/2/2022 16:39

Goodness this is old ground. Been there. Done that. Brought the T-shirt (many thanks). Result still the same.

If the PK result is poor, as is probable, the new partner will run a mile, recovering as much as it can.

[nobbygnome] 10/2/2022 16:34

Some curious posts this afternoon. So a few points.

1. I currently have no position long or short in IMM and haven't done for a number of months. The last time I traded it as stated here I made a small profit.
2. I have never worked on Lupuzor......but I have done extensive research looking at the science behind the drug
3. Bendaddy. Why are the FDA asking for this information which as you point out they should know already. This is the key question the company hasn't answered! The drug didn't work in the Phase III because they didn't use anything like a high enough dose. All their experiments show this to be the case. Remember they have never ever hit a primary endpoint in a completed clinical trial! It doesn't work at this dose but may at a much higher dose....

[victor2] 10/2/2022 16:27

Perhaps Nobbygnome needs to come clean and explain to us why
the Lupozor drug he was developing and working on failed?
What was the problem with your drug so we can understand ANY similarities
here? I am no expert, but isnt a PK study standard before this type of patient
trial begins? After all it would have been 6 or 7 years ago that IMM first
approached the FDA and commenced its first phase 111 trial so logical given the advancement in technology we have an updated PK study.
Im optimistic and hope its no more than getting an up to date picture before
approving a 2nd phase 111 trial on patients.

[bendaddy] 10/2/2022 14:18

RE: PK study and dependency of new P3 approval on positive results. Given P140's half-life and MOA, the FDA should not expect to see P140 in the blood for very long after dosage. IMM's Feb 21 report clearly states 'We do not expect a significant amount of the drug to be circulating in the blood, in-line with the unique mechanism of action for the drug which educates the immune system to stop attacking its own tissues, in a similar way that the current mRNA COVID-19 vaccines administered intramuscularly'.

So Nobby what are you really saying about dosing, mechanism and site of action and pharmacological effect? Do we not think that the original P3 result vs placebo was simply skewed by the Mauritius and possibly the US cohort receiving better SOC during the trial therefore a better designed and recruited P3, focused on the dsDNA antibody cohort might very well succeed?