Immupharma Share Discussion Threads

[nobbygnome] 08/2/2022 09:11

My understanding is there were some issues with the higher dose so I think it would not be possible to up the dose at least in one injection. You could have more frequent injections but you need some evidence to justify the dosing regime you choose. I would guess another PK study at least would be required comparing a few different doses.

[mcdermov] 08/2/2022 06:10

If the PK study pans out as you expect, surely FDA will only permit P3 to go ahead at a higher dose, or will IMM be required to do an earlier phase study establishing safety of a higher dose before P3 can go ahead?

[nobbygnome] 07/2/2022 10:30

>> city chappy

That is exactly what I am saying and have been for years. As for why the FDA are asking now is an open question. Of course the blood levels of the drug are so low they could not be measured previously because the assays were not sensitive enough. However, assay technology has improved exponentially so now they can.

For me the major question is the site of action of the drug which the company has been inconsistent about over the years if you look at the scientific publications. The fact that the FDA has asked for it to be measured in blood would suggest they don't consider the site of injection is where it works otherwise why measure it in the blood. When they see the vanishingly low concentrations which disappear in a few hours, they could be very concerned. For clarity the half-life of any peptide such as Lupuzor will be very short as it will disappear through the kidneys rapidly. That is not in doubt....

[nobbygnome] 07/2/2022 10:21

>> Ben

I do have the papers somewhere about the in vitro and animal model data. Therein lies the problem because all that data shows the concentration required to get an effect will never be reached in patients except briefly at the site of injection. My concern is that the FDA have cottoned on to this fact. I did in fact email the FDA about 4 years ago pointing out this issue although only got a standard notification reply so have no idea if anybody actually followed up that message.

As s_k says the PK results could be critical for the phase III to proceed. A binary situation....

[sicilian_kan] 07/2/2022 10:05

Thanks Colsmith and I agree re copper. I've been looking for sometime for a way into EVs with an exponential growth stock and not one like Tesla where the price rise has already been built in. Greenroc is the first company that has fitted my brief and am looking for more.

Re IMM, in my view the PK study is critical and it could make or break P3. The good news is that it is not long to wait now for the outcome and the direction of Lupuzor (P3 or not) will shortly be shown.

[colsmith] 07/2/2022 09:52

SK interesting mining stock, another commodity in short supply that powers everything electrical is Copper - demand is forecast to cause supply issues over the next few years; electric cars need this stuff and it takes more of the stuff than the ICE lot! A few stocks that look for copper are out there.

[bendaddy] 07/2/2022 08:54

Nobby - do you still have access to the original in vitro / pre-clinical PK/PD and dosing data that presumably showed sufficient activity in the body and confirmed the MOA before the original P2/P3 trials were allowed to go ahead.

[sicilian_kan] 07/2/2022 08:49

In case anyone is interested, I've just set a new thread on Greenroc, which can be found here:



I'll hopefully be updating the header here at Immupharma once the PK results are out too.

Best wishes all,

s_k

[1bond] 07/2/2022 08:42

Surely the PK study is only to confirm to the FDA how drug is absorbed and passed round the body and excreted. Once that is known, I cannot see why the FDA would not give approval for a Phase 111 trial. Presumably these types of PK studies are very common in the biotech world

[city chappy] 07/2/2022 08:28

Nobby can you explain that a bit more. Are you saying the doses are too small to be effective so any effectiveness would just be coincidence? What then is the purpose of the PK study?

[joeblogg2] 07/2/2022 08:12

I cannot think Avion would be that stupid investing without seeing this???

[nobbygnome] 07/2/2022 07:42

Yes. I'm still not convinced the phase III will go ahead. On the balance of probability I guess it will but you have to ask yourself why the FDA have asked for a PK study....

[david gruen] 07/2/2022 07:35

LUPUZOR(TM) UPDATE

PK study commencement approved by MHRA - patient dosing to commence imminently

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to provide an update on the Lupuzor(TM) pharmacokinetic ("PK") study, as part of the new optimised international Phase 3 trial of Lupuzor(TM) in Lupus patients.

Key highlights

-- Medical and Health Products Regulatory Agency ("MHRA") approves commencement of the PK study
-- Volunteers have been selected and approved for inclusion in the PK study
-- Volunteer dosing to commence on 15 February 2022
-- Study on track to deliver results around the end Q1 2022
Following the approval from the US Food & Drug Administration ("FDA") of the protocol for the pharmacokinetic ("PK") study and local Ethics committee approval, ImmuPharma has been working with Avion Pharmaceuticals ("Avion"), our exclusive US partner, and our Contract Research Organisation ("CRO"), Simbec-Orion, together with additional specialist service providers, to prepare the commencement of the study.

As part of the regulatory process, the Investigational Medicinal Product Dossier ("IMPD") required significant revision, due to the inclusion of a new proprietary synthesis of P140, which consequently affords greater IP protection and lower cost of goods. The new IMPD was submitted to the MHRA and, following a full review, the MHRA has approved the commencement of the PK study.

The PK study is a Phase I study to assess the presence of Lupuzor(TM) in the body after administration of a single dose. The study will be carried out in a total of up to 24 healthy male volunteers.

Volunteers have been selected and approved with dosing to commence on 15 February 2022. As previously advised, we expect study results to be available around the end of Q1 2022.

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

"We are extremely pleased to see this next positive step for Lupuzor(TM), with approval from the MHRA to commence the PK study. We look forward to moving Lupuzor(TM) forward into the optimised Phase 3 study, in collaboration with our partner Avion, on the successful completion of the PK study. The study is on track to deliver results around the end of Q1 2022."

Dr Tim Franklin, Chief Operating Officer, added :

"The ImmuPharma Biotech team in Bordeaux and I are looking forward to the near-term completion of the PK study. Our CRO, Simbec-Orion, and other key collaborators including Prof. Sylviane Muller, have provided invaluable contribution in completing a robust and improved IMPD to the MHRA. We look forward with Avion to moving Lupuzor(TM) forward and in parallel, we will continue to focus on unlocking further value through the other indications within the P140 platform and the anti-infective programs."

[joeblogg2] 07/2/2022 07:25

Still negative Nobby? Morning all

[nobbygnome] 07/2/2022 07:13

So dosing starts on Feb 15th. They might as well finish by the 16th because there won't be any drug left in the body by then. The real question which remains unanswered is why have the FDA asked for this study to be completed and is the phase III dependent on results from this study to go ahead. If so what results are required. As I said the drug will be all gone by th second day and there will be nothing left for the remaiming 27days of the dosing cycle. Will that be sufficient for the FDA to say fine, go ahead.....the six million dollar question?!?

[sharetalk] 20/1/2022 08:39

"Ethics committee approval has been granted and volunteer screening and selection is expected to begin in December 2021, with dosing of volunteers in January 2022. Guided by our CRO, study results are anticipated to be available around the end of Q1 2022. Throughout all these preparations we have been liaising closely with Avion, and on successful completion of the PK study we will be actively moving forward together to commence the international Phase 3 trial of Lupuzor(TM)."

[sharetalk] 20/1/2022 08:34

Due results from the Lupuzor PK study around the end of this Quarter:IMM, 18/11/2021Key highlights-- Lupuzor PK study on track to deliver results in Q1 2022 and to move into Phase 3 thereafter.-- P140/Lupuzor: new proprietary synthesis of P140 giving greater IP protection and cost efficiencies.-- P140-CIDP moving into a Phase 2/3 adaptive registration clinical trial in 2022 with anticipated 'orphan drug' designation. Commercial partnering discussions ongoing.-- Professor Sylviane Muller & CNRS relationship strengthened to exploit P140 opportunities. -- BioAMB: Excellent results from pre-clinical study, with further significant updates anticipated in H1 2022. Commercial partnering discussions ongoing.

[thordon] 10/1/2022 22:53

only have £4k invested , but know others are underwater.
To me this is low to medium risk as the key investors have a stake mainly Avon who are paying for the upto £25 million 3rd stage trail.
As only started investing two years ago after 20 year gap have learnt and spread my investment across 10 companies and growing.
My old head said place the bet all in.

[phatomtraider] 10/1/2022 17:33

some large trades today. One declared after hours bang on the mid-price for 375k.Something happening?

[chadders] 10/1/2022 08:05

That looks like a vote of confidence to me

[sicilian_kan] 07/1/2022 10:28

There is also a natural 11p to hit, that being the price that Alora bought £1.2m shares at, just before Christmas.

[1ultimate] 07/1/2022 09:02

All buys this morning…the highest paid is 7.96p for 87,888.

Looking nice and STRONG imho

[wololol] 07/1/2022 08:06

Hopefully break above 8p today

[sicilian_kan] 05/1/2022 14:27

The best point in IMM's favour is that on 20 December, an insider (IMM's commercial partner) that will know everything about the FDA application and the PK study, has chosen to invest £1.2m at a premium of 11p. The current share price is clearly undervalued and is likely to head towards that figure.