The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
We are just beginning to get serious on the trial movement and aiming for the first major inflection point which is ph1b.
These point from todays RNS doesn't seem like the game is up-
This follows approval by the safety review committee granted upon review of preliminary data generated from the initial three cohorts in the single ascending dose part of the study. The committee deemed these data as satisfactory for the multiple ascending dose part of the study to commence, as well as for continued dose escalation in the single ascending dose part of the study.
And Dr Mitchell-
"We are delighted that the data generated to date supports the safety review committee's approval to begin dosing the first subjects in the multiple ascending dose part of our Phase 1a trial of SDC-1801. Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily".
If safety was not nailed on then we would not be mentioning PK findings demonstrating the capsules ability to be given to patients in hospital or otherwise.
For context- Abbvies Humira pulls in $1bn per month and is intravenous (injection) with loads of issues and some people cannot have it due to safety- what we are promising is not only a safer treatment but potentially no hospital visits as a capsule can be taken anywhere.
Still waiting for the death spirally crossy thingy because I would love to add to my ISA.
Forever, stop falling chap and just invest.
If the price goes down we add as the longer term prospects for Tyk2/Jak1 and Chk1 are blindingly obvious.
Once we get to ph1b efficacy (the industry sees the pk data, tolerance, dosage and trial design for all future patient trials) not if as 12wks into ph1a safety trial without it being stopped then a re-rate upwards will be a given as Tyk2 is all the rage at the moment and we are Tyk2 Jak1 even safer.
Todays move to a multi-ascending trial alongside the current trial underpins in my opinion the safety of 1801.
For heavens sake that's the US Damion.
They over ..x everything or boosting as it is called. We do it better here in the UK i.e. only present the data when it's good and ready.
We will just have to wait until Jan to see the PK data and relevant results to see if there were any adverse effects but as Sad has pointed out ph1a generally follows suit to pre-clinical and the fact we are moving to a muti-ascending trial alongside the existing one after 3 cohorts looks very promising from a safety point of view- well in my book anyway otherwise the safety committee who are controlling everything would not have given the green light for it to happen.
Damion, I have never seen a company post detailed data esp. adverse effects so early into a ph1a trial.
Normally you would see that type of detail in the pk data at the end of ph1a as this would be what would be presented to set the dosage amount etc. for the trial design going into ph1b.
If there is can you point it out so I can have a gander please.
From todays RNS-
This follows approval by the safety review committee granted upon review of preliminary data generated from the initial three cohorts in the single ascending dose part of the study. The committee deemed these data as satisfactory for the multiple ascending dose part of the study to commence, as well as for continued dose escalation in the single ascending dose part of the study.
And Dr Mitchell-
"We are delighted that the data generated to date supports the safety review committee's approval to begin dosing the first subjects in the multiple ascending dose part of our Phase 1a trial of SDC-1801. Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily".
If safety was nailed on then we would not be mentioning PK findings demonstrating the capsules ability to be given to patients hospital or otherwise.
Abb
vies Humira coups in $1bn per month and is intravenous (injection) with loads of issues- what we are promising is not only safer treatment but potentially no hospital visits as a capsule can be taken anywhere.
When the death spirally crossy thingy coming again magy pum as I want to top up big style for the inevitable ph1b inflection point?????
Well well well, so we are going at 150mg in both thr single and now multi-ascending dose.
I don't know how anyone else interprets that, but for me that's massive plus for safety as we only needed 3 cohorts rather than 6 to pass to the multi-ascending trial.
Many happy returns chaps, fantastic news and safety insofar looks nailed on more so than ever as the safety committee must be seeing no issues whatsoever at the moment.
If I was ramping you would see rocket, to the moon etc etc.
It's enthusiam not ramping you t.at, maybe over enthusiatic yes- but then I have seen my 30k investment go as low as 9k as high as 300k and everything inbetween even after selling half to meet costs associated with my fathers death I am in healthy profit and Sareum are a totally more validated company then when I invested over 10yrs ago- so anyone who has been through a similar path as me would be a tad bit enthusiatic now we are finally in clinic first dosed on 6 June and the safety committee have not pulled the plug.
Absolutely SCHeck, him and it's pet dog sorry puma promised us a 20p death spirally placing thingy majig a couple of weeks ago and I am still waiting.
I doubt a 50p death thinga majig won't happen either- give over thou two t.ats
Ajithoth, that isn't going to help- there is a massive death cross in the sky and a big a.. helter-skelter with c..wombles and t.ats scrolled all the way down the side of it in neon lighting smack bang in the middle of pamisford- we are well and truly royally fooo.d. 🙃