Hot, that will be after the pk and biomarker data results come in- we will then see the ph1b trial design which will determine all the dosage and trial designs for all future trials up to commercialisation in Psoriasis or any other indication a major wants to utilise it in.
Leggster, on the last trial posted around early Sept it did say this in the trial design.
Each participant will be in the study for approximately 9 weeks (Screening Visit to Follow-up Visit) and will receive 2 doses of SDC-1801.
So that would indicate a RNS for around mid to late Nov for the Multi-ascending trial but then we have also just started the Food effects stage as well so maybe they will wait until full data is available in Jan.
Aye I'll second that Blastoid, he put some good context into the post. Kool on the other hand has been fudt.attering for a while esp. when we were pre-clinical.
Remember this Kool the last time you were having a go-
Ahfam3
Posted in: SAR
Posts: 3,416
Price: 97.50
No Opinion
RE: Wow16 Mar 2023 20:03
Nah Kool, it's precursor to Sealioning (uber c..womble types but worse). And as we get closer to and get to clinic and transform into a clinical stage company it will get worse.
Then as we go through ph1a, b, 2 etc. and progress through different cohorts etc. more of your type will turn up under the false pretence of balanced, reasoned debate etc, then claiming victimisation when your called out and so forth.
It's a long-term most are not invested and working for people or entities to short, lower entry etc. AIM is full of them and I have seen it for years on other shares boards for over 5yrs+.
https://en.m.wikipedia.org/wiki/Sealioning#:~:text=Use%20of%20the%20term%20originates,following%20the%20characters%20into%20the
Busted I think comes to mind. Don't worry though we understand your concern and it will all be put to ease when the ph1a data, pk, biomarker and ph1b trial design get announced in Q1. In the meantime you can sit on edge hoping Chk1 news doesn't land out of the blue.
Toodle pip now.
Siennaj, Sad has already answered this many times before Gsk have their own chk inhibitor which in ph3 so didn't want another one yet.
And also the fact that our chk1 is mix ot vimto and ribena c...tail but don't tell pummy and maggy or they'll hit us with the death cross before going all out on the death spiral helta-t.atterskelter.
That should read 1801 given to patients as per the RNS statement as follows-
"Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial".
Common Silver, ph1a is pretty much in the bag- we have moved to food effects study withn the already dual ph1a. And also stated that 1801 can be given to patience from pk findings- if all that doesn't show 1801 is safe then I have no idea what does.
The rest of the trial in my opnion is a formality. For me when the safety committee moved to the multi-ascending dose study after just 3 cohorts I was convinced we had nailed ph1a don't know about anyone else though. The need to obtain biomarker data in ph1a is even more encouraging as well.
We just need to see the ph1a data readout in Q1 to view how safe 1801 any efficacy signals from the biomarker and pk data and what the dosage and trial design ph1b will be at.
Spif, obviously you haven't listened to the pro-active invest vid where Dr Mitchell has stated if the price is right then we could licence or sell prior to clinical and I am sure he also mentioned this again in the investor meet.
It is obvious why we want to negotiate after ph1b as it validates efficacy we have all the data published etc. etc.
However, as I mentioned if we show early signs of medium to strong efficacy anywhere in ph1b then considering we are a once daily capaule with little to no safety issues utilising Tyk2/Jak1 pathway- and the majors have seen a pure Tyk2 get FDA authorisation plus the market leader in Psoriasis is pulling in $1bn per month intravenous and has loads of issues. In my opinion I cannot see a licencee waiting until of ph1b readout to do a deal esp. as they would be paying treble.
Remember Dr Reader has already said getting to ph1b is gamechanging as we then get to compare against Pfizer- so there is already clinical validation at ph1b all we need is signs of efficacy and as prev. stated we will easily be £7-10 in a shot before any licencing deal as you need to report on each cohort and we will know then.
Many happy returns chaps- the fudt.attery is trying hard but unfortunately for them we have some well researched posters on here that know there is a massive price to progress disconnect already.
There's no guarantee for anything really except death. But to think we get efficacy in ph1b and no safety concerns given we have already pretty much moved a year forward with the trial after going MAD stage after just 3 cohorts due to safety committee assessing safety of 1801.
Well then we can only assume really can't we that here we have a once daily capsule against a market leader injection but with a significantly better safety profile and no one is going to licence- I would bet a larger percentage chance of a licence prior to end of ph1b then at the end of it in my opinion.
Afterall the majors are no looking at safer and more efficient treatments hence Sotyktu's FDA approval without blackbox warnings and Takeda Nimbus 4bn Tyk2 deal.
Oh and trial designs can change- remember we were going to do 6 cohorts before we went to the mult-ascending doae trial of ph1a. However, the safety committee stepped in and changed the trial to dual SAD and MAD after just 3 out of 6 cohorts.
So we would have looking at ph1a data end of 2024 then ph1b in 2025 but instead we are now looking at ph1a Q1 2024 and ph1b right afterwards.
And remember the safety committee is in charge of the whole trial, timelines, dosage, people etc. Sareum are only reporting now.
Spif- so you telling me then if 1801 show medium to strong efficacy in ph1b with a favourable safety profile remember the biomarker data- then big pharma will wait until the end of ph1b to deal up. Considering market leader Humira has loads of safety issues is intravenous (injection) but pulls in $1bn per month.
You better revise that timeline sweetie- 1801 will be once daily capsule and we have already been told it is suitable for patients not healthy volunteers like ph1a is insofar-
"Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial"
Now you have to ask yourself why would mention patients being able to receive 1801 in capsule form if safety wasn't being aced and they are mentioning pk data already which means they already have grasp of how good 1801 is.
The pk data will determine all the dosage and trial design for all future trials up to commercialisation it is a biggy and what will drive the upward shareprice momentum once we receive some efficacy data in ph1b trial.
Potnak, the facility is there for one reason that is to get 1801 to ph2. It is serving it's purpose qnd the price will follow suit when we get to ph1b and receive some efficacy a licence deal will no doubt be signed in my opinion.
I am not worried as seen this drop which was more severe to 0.0025 which would equate to 12p in todays money and that was pre-clinical and we hadn't even formulated sdc-1801 into a capsule yet.
There is a massive price to progress disconnect and that is the only red flag here to be honest. This paragraph from a recent RNS states everything we need to know and today food effects milestone only builds on this (we are benchmarking dealing with patients not voluneers now the biomarker move is simply to build a data rich ph1a readout for potential licencees and investors)-
"Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial".
If the ph1b trial shows medium to strong early efficacy this will be £7-10 in a shot as world leader in Psoriasis is Humira intravenous (injection) and has s.it loads of issue but still pulling in $1bn per month- 1801 will be capsule and does away with the idea one has to go to hospital for treatment for starters.
It will also strengthen the Tyk2 Jak1 pathway for safety and efficacy and in turn will validate somewhat the 1802 compunds in immuno-oncology but don't forget 1802 also has a new US auto-immune patent.
Agree Leggster- there intiative to take 1801 to Aus has been clinically rewarded immensily insofar with the food study another major milestone.
Also the 1802 US auto-immune patent along with the Chinese and Japanese 1801 patents securing the best part of the Asian market are master-strokes in my opinion. Cannot wait for the ph1 pk and biomarker data and ph1b trial design