Immupharma Share Discussion Threads

[nobbygnome] 20/4/2022 08:53

>> bobdown

An interview with McCarthy never clears up anything; he is the master of obfuscation!

[nobbygnome] 20/4/2022 08:51

>> Pwhite

But the drug still has to work; Lupuzor has so far failed to provide any evidence that it does. Remember it has never met a primary endpoint in a completed trial yet.

I find it extraordinary that you have invested in a company with dodgy management and a dodgy drug. You are all over these boards pointing out to investors the issues about companies (often correctly) but then choose to invest in one of the most dubious of the lot. Yes you will make money in the short term if the phase III trial does indeed go ahead. However it would be good to hear that is your goal if it is the case rather than this disingenuous nonsense trumpeting the long term prospects of the company!

[bobdown2] 20/4/2022 08:36

I find that reading the rns statements a few times gives a better perspective than one persons continual take on the company. It can save lots of time if you get an aggressive poster.
What would be good would be an interview with the CEO on vox reports or similar. It would help to clear some of what some think is not what the rns actually says.

[pwhite73] 20/4/2022 08:31

Nobbygnome - "...Need I say more…"

Yes your technical knowledge is much appreciated here but you must also try to get to grips with the changing market place for drugs. Tailoring or targeting drugs for specific patients is now the modus operandi of the FDA and medical regulators as opposed to one size must fit all.

For example you have 100 lupus patients. Drug A is effective with 98 patients and drug B is effective with only 2 patients. The 2 patients drug B is effective on are the 2 patients drug A has no effect on. Previously the FDA would have failed drug B on the grounds of no significant improvement over standard care. Today it will not. So long as drug B has no adverse effects the FDA will allow clinicians to administer drug B to the 2 patients it works for.

That's the change that's happened in the drug market over the last five years. Lupuzor will be granted FDA approval that's why Avion have invested $25 million in it.

[sicilian_kan] 20/4/2022 07:54

Hi nobby, in those patients with the anti-dsDNA marker, the ones they want to redo the P3 trial on, the P3 results were 61.5% active vs 47.3% placebo, at p=0.0967.

[nobbygnome] 20/4/2022 07:51

A p value of 0.2631 in the first trial was nowhere near to significance! Need I say more…

[pwhite73] 19/4/2022 23:18

Immupharma has stuck with Lupuzor because investigational teams, big pharmas and patients have requested they progress the drug further as there is a need for it. That's why Avion are funding it to the tune of $25 million.

Lupuzor proved more effective than a placebo but did not show significant improvement over standard care back in April 2018. However the FDA's position has changed on granting commercial approval. There is now a greater emphasis on getting drugs into the market so long as there are no safety issues and let the clinicians decide what's best for their patients. Lupuzor has shown no adverse effects this is why Avion has taken it up and will commence with a Phase III trial. If there still remains no safety issues and only a slight improvement on the last Phase III trial the FDA are likely to grant commercial approval.

Drugs can fail Phase III endpoints and still be granted market approval as an orphan drug if there is a need and market for it. Aldoxorubicin being such an example. Since Covid the environment is much more favourable for Lupuzor and drugs at Phase III. The FDA came under heavy criticism for not having any drugs in the pipeline even remotely capable of addressing Coronavirus.

[nobbygnome] 19/4/2022 21:22

Oh and Lupuzor is used neither at a high or frequent dose as 200ug is injected every 28 days....

[nobbygnome] 19/4/2022 21:20

So 30 mins max according to that paper. Actually I think Lupuzor will be longer because it has a slightly unconventional structure

[nobbygnome] 19/4/2022 21:19

From the paper below

One of the downfalls of peptides is that they have a poor pharmacokinetic profile – that means they do not circulate in the body for a long time. The half-life of a peptide is usually between two and 30 minutes, after which they are quickly filtered out by the kidneys. This means that any treatment they carry only has a very short time to reach the part of the body where it is required. To compensate for this short window of activity, peptide treatments are often administered in high and frequent doses. This obviously has an impact on the patient experience and increases the cost of treatment.

[nobbygnome] 19/4/2022 21:13

The peptide will be exactly the same structure used as last time so no difference there. It sounds like they have changed the manufacturing process for IP reasons but the end product will be the same.

And we don't yet know the half-life because the company hasn't told us. Previously they couldn't measure it in blood so a half-life calculation was impossible. So they would only have got this result from the recent PK study using more sensitive assays but didn't include the data in the RNS for some strange reason. All low molecular weight peptides have a very short half-life in blood because they go straight out the kidneys and also will be susceptible to peptidases in blood and tissues. I reckon a half-life of 5 hours max......yet it's supposed to be still working 27 days later.

I just saw a pig flying by.....

[bobdown2] 19/4/2022 21:03

The funding was a good move. 11p strike price and two warrants attached to each share at the same price. A possible scenario is that not all warrants are exercised at the same time. If I had the chance I would wait for a higher price before I exercised mine to lock in some of the profit. If the lupus peptide is successful then some more value has to be added to the other main candidate and other interests in the stable.

[thordon] 19/4/2022 20:41

Do like these debates but there's a question why did Alora Pharmaceuticals LLC invest on 20th December 2022


Subscription for 10,909,091 new Ordinary Shares ("the Alora Subscription Shares") by Alora Pharmaceuticals LLC ("Alora"), the parent company of Avion Pharmaceuticals LLC ("Avion"), with whom the Company signed a licence and development agreement in November 2019 for the exclusive rights to Lupuzor™ in North America (United States), to raise £1.2 million (the "Alora Subscription").

At 11p per share

Also P140 is a upgrade of existing drug going through IP at present and was included in the PK Study.

[scrabster1] 19/4/2022 20:15

In complete agreement with Nobby. Dose size is the major issue here, definition of madness is repeating the same experiment but expecting different results. Look at the half life of the drug at that dose and ask yourself if you think it can have any therapeutic effect for the length of time it is in the body. Nobby or anyone, can you recall what that half life is ? Crabs.

[nobbygnome] 19/4/2022 19:45

Do you know the history Mr White? The drug spectacularly failed in phase III last time. They then did a dubious post hoc analysis on a small patient group and saw some apparently good results but of course the trial wasn't powered for that endpoint. They have gone ahead with the same dose as last time (this is the major problem IMHO) so no real reason to think the result will be different this time. Don’t forget Avion paid nothing upfront for this allegedly phase III ready drug which says all you need to know about the chances for the drug….

[pwhite73] 19/4/2022 15:10

The company has to formally request the start of a Phase III trial and lay out how it intends to proceed. The FDA doesn't just grant it because the PK study meets its endpoints. Avion would be in the process of speaking to other partners as Phase III is likely to include several hundred patients in several countries.

The share price action looks like the usual routing after a spike. Triggering stop losses, forcing T traders to close at a loss and profit taking. Phase III is where major drug companies and institutions take an interest for next comes approval assuming all goes ok. When a drug enters Phase III even before approval it is of major interest to big pharmas because many facets of the patented drug can be applied to other medical areas.

[bobdown2] 19/4/2022 15:01

The price is telling that there has been good news and the mms need to sort out their books. A drop in the share price does not tell you information that has not been given. Lupus is not a pleasant illness especially if it comes with another complaint and you cannot treat that one. Hopefully stage 3 will be the prelude to a drug that will help those with lupus !!

[bobdown2] 19/4/2022 14:45

Not argueing with that. But it reads o.k to me.

[nobbygnome] 19/4/2022 14:42

Let’s be frank, the price is suggesting there is a problem with the data…..but who knows

[nobbygnome] 19/4/2022 14:41

If the FDA had approved the phase III to proceed it would have been RNSed. That information was NOT in the last RNS…

[bobdown2] 19/4/2022 14:15

Mms may have balanced their books from the spike. Buys have over taken sells now. A nice slow movement upwards would now be appreciated.

[tomboyb] 19/4/2022 13:47

Ask back up above 7p -

There was a big spike to over 150p 2017 / 18 -

There will be a spike when we get news of the Phase III trials -

[nobbygnome] 19/4/2022 13:20

>> tom

It all depends what the FDA wanted to know before they cleared the phase III. If they required a particular half-life and in reality it was significantly less, they could well pull the plug!