In the Lupuzor update on 19th June there was the following statement
‘Following the receipt of comprehensive guidance from the Food and Drug Administration ("FDA") in 3 separate Type-C meetings, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor(TM)) in patients with Lupus will commence in H2 2023.’
So the guidance from the FDA was for a phase 2/3 adaptive trial. However IMM have now ditched that advice and are going for a straight phase 3 albeit with dose ranging built in. That’s going against the FDA advice and usually that doesn’t go down well…. |
How do you conclude they are going against the advice of the FDA? |
 Reilly on the face of it looks like he has a good cv but he has his work cut out to up the game of the current management team. What they really need is a lupus expert because it is such a tricky indication….
And wrt the FDA it’s not impossible they had a quick phone call to ask a few questions about the new approach. However since it’s not an official meeting (which would have to be RNSed) then there is nothing on paper about any advice given.
During my career I had a classic example of how you ignore a regulator at your peril in this case the EMA. The official guideline was to do a 12 month trial in a particular indication. After advice from physicians the company I worked for decided to do a 6 month trial, which of course was cheaper and quicker. They thought the EMA would approve it anyway because there was such a high unmet need. In the event it was refused and is still not on the market for that indication 13 years later. I went to the appeal meeting as the scientific expert and I have never attended such an unpleasant event. They were never going to budge because the company hadn’t stuck to the regulations despite the fact the drug was efficacious! A salutary lesson…. |
I was invested in IMM for several years before the Phase III trial. Thanks to posts like yours I had doubts about the efficacy of Lupuzor and sold out before the trial results were announced when the share price was sky high. |
Nobby-In August Dr Laurence Reilly joined the Board. To a layman his CV looks impressive and very suitable for IMM's needs right now in terms of progressing their portfolio. What is your thinking?
Could they have approached the FDA and got a positive response to the modified approach?
Thanks! |
And I’m not sure they do have the support of the FDA to go straight to a phase III trial. In June the company said
‘Following the receipt of comprehensive guidance from the Food and Drug Administration ("FDA") in 3 separate Type-C meetings, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor(TM)) in patients with Lupus will commence in H2 2023.’
So it would appear they are going against the FDA advice which has to be a regulatory risk. You ignore the advice of the FDA at you peril…. |
Funny how a number of posters including past IMM shareholders seem to hate me. Ho hum….thanks for the kind words |
Nobby
Thanks-have to say you are the most informed of all participants on the boards I inhabit.
Think news is positive with still more to come re CIDP and ROTW. Will buy some more tomorrow. |
Looks like Nobby was correct all along. The new phase three study will proceed with significantly higher doses than the previous trial. Well done Nobby. |
>> 1bond
Well the trial is starting later than anticipated so I’m not sure much time will be saved overall.
>> clint
Of course we don’t know the trial design yet or even the overall number of patients so it’s difficult to predict how long the phase III will take. In the previous phase III patients were on the drug for 12 months so if the same is true here, even with the proposed interim looks, we won’t get the first lower dose results until at least the end of 2025. So for a completed reported trial we are likely to be looking at 2027…
However I must stress until we see the detailed trial design it’s difficult to make an accurate forecast! |
Nobby-regarding Colsmith post-when would you anticipate phase 3 trial to complete ish? |
Second RNS this afternoon informs that Lanstead have been selling, but if they've now stopped!
GLA SR |
Everyone appears to have failed to recognise, or skipped the most important part of todays RNS:
The direct Phase 3 route is faster to filing for approval whilst also incorporating FDA's request for demonstration of a dose-ranging in the pivotal program.
This is huge news, and cuts down the timetable considerably, and puts the company directly into Phase 3. |
My thoughts - this could go up or down; an optimist might say its looking good with the FDA behind the trial etc; whilst a pessimist might say I don't believe a word of it. whatever, sure some interesting trades. |
>> s_k
A penny for your thoughts? |
Indeed you did nobby. Guess the time to take a punt might be once they have decided on the correct dose. Quite possible they will need to alter trial to increase number of doses? |
And they have missed their timeline of saying the trial ‘will start in H2 2023’ announced in the interim results at the end of August so less than 4 months ago. I can’t see it starting in Q1 2024 either but we will see… |
A paragraph from the announcement today
‘ After three FDA guidance meetings, further human and animal pharmacokinetics studies and reconciliation with efficacy demonstrated in the animal models, it was concluded that the previous dose used in clinical studies was too low. The new Phase 3 study will include dose-ranging up to 15 times higher than the original study dose of 200 micrograms.’
I came to that conclusion 6 years ago after looking at the data the company itself had published . It really wasn’t difficult for a scientist trained in the field and begs the question how on earth did they decide to conduct a trial with a dose which was way too low. Shareholders should be asking serious questions of the company…. |
So if you read my post above you will know that I’m not sure Simbec-Orion are the best choice here and would have preferred a big CRO. And the increase in dose is a massive 15 fold although I’m not sure this will be enough given as a single dose because of the extremely short half-life. More frequent dosing was the way to go IMHO.
Anyway of course it has a better chance of working now although on balance I think the dose is still not high enough so it remains a big gamble for shareholders. |
<< Clint
The worrying aspect is that Avion have no experience in SLE which is a notoriously difficult indication and very competitive because there are so many drugs in trials. I hope they appoint one of the big CROs to run it as otherwise they will rapidly hit problems. From memory IMM previously used Simbec who are far from ideal… |
Hi clintdavid1, that must have been quite something playing in that team. The late Penrose was legendary.
Yes, my name is based on the chess opening. I play a bit in my local leagues and in some tournaments. |
This is like poker. We have good starting hand -say KQ suited-but it needs improving. The flop needs to do this-say 2 cards in same suit-a K or Q, or A J not suited or J10 not suited etc. In IMM terms, we need to know the trial is going ahead, a company appointed to run it and what progress has been made on others issues such as CIDP, RTW etc.
The final 2 cards-a long time off-the turn and the river (of dreams) will determine whether we have a winning hand-that is drugs actually coming to market and real revenue streams.
SK interested is your name based on E$ C5 chess defence. I used to play in same Hampstead team headed by Penrose, Israel, Cornforth, Blaine et al in the mid 60's. Are you a chess player? Good to see you back in again. |
Some interesting trades this morning. A leak perhaps… |
Having said that it will be interesting to see what dosing regime they have chosen. My initial calculations made all those years ago suggested that around a 50 fold increase was required…. |
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