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In at under 1p old money. Not a huge amount but 1.5k. Cant help but feel this is so cheap.
In other news, sold out of helium one last Thursday, it’s done 300% since then 😂 such is life lol
Come on SAR!!
It’s an ill wind…. https://stocks.apple.com/ASgS7kgITTD-Pn0h9txwQ6g
I hate just about sums it up Gunner68.
Data required re safety profile, minimum
Biomarker data up the price.
Psoriasis data if we still have 1801 after the above but considerably higher value following satisfactory results.
At this stage if a large pharma, will want 1801 in its entirety l would think and consideration in 1802.
Regards
Question 10:
Assuming the Board has a strategy in place for the commercialisation of SDC-1801, could you outline some of the factors taken into consideration during the planning?
Our Board has conducted market research to identify which companies are most likely to consider in-licensing a product such as SDC-1801 and to understand the strengths and weaknesses of our competitors. We also have a continued dialogue with potential partners to understand what they need to see in a data package before committing to a licensing deal.
GLA
Trial timelines cont.
Trial should play out similar to the picture link below with 6 cohorts in the SAD and 4 cohorts in the MAD gives a clearer idea of where we are at with the dates in previous post.
https://www.researchgate.net/figure/Study-design-with-overlapping-SAD-MAD-cohorts-where-treatment-periods-took-place-in-a_fig1_299547400
The Food Effects (FE) study is usually conducted with 2 cohorts of 8 healthy participants from the SAD study. (Unless they recruited separately) Subjects from FE Cohort receive the study drug under both fasting (in a first period) and fed conditions (in a second period) with a washout period of at least 14 days between dosing of the fasting and the fed periods. The FE Cohort can be dosed in parallel of the SAD Cohort receiving the two higher doses.
It will ensure that a dosing schedule is safe to administer at 300mg per day. It does not place any limits as to higher dosing that may be required in different Indications.
A lot will depend on potency of compound.
The crucial stage of data results will soon become available and hence further waiting game, nothing we can do at the moment. We will have early data but l not think that sufficient to warrant RNS.
I presume that Sareum are still in discussions with interested parties. They will require comprehensive data to start the ball rolling.
Regards
Regards
Trial timelines:
(6th June) Approaching 8 months since the first subjects in the SAD were dosed.
*** 4th Sep First 3 cohort’s of 6 data reviewed authorising MAD study ***
(4th Sept) Nearly 5 months since the first subjects in the MAD were dosed.
(9th Nov) Nearly 3 Months since the first subjects in the Food Effects were dosed.
Looking at similar size P1 trials we can’t be a million miles off based on the amount of cohorts we have in the MAD study (4 cohorts). The SAD part should be well completed and data analysed some report this with some data via RNS some don’t that’s for the Bod to decide.
I think at the end of the day we all would like to see a decent PR push at the end of P1a something NG was really good at during his time at Sierra. Something similar to Ventyx TYK2 P1 results below would be welcomed.
https://ir.ventyxbio.com/static-files/86f7fa3c-c39a-4cc5-b057-4bca3fd752b7
--------------------------------------
It’s interesting but it’s also very complicated and not something you can ever rush, even though we get frustrated on time scales. What is the dosage that’s deemed acceptable, as in 300mg dosage etc.
However, l will add that as as a capsule formulation it may well be that it is not essential to take on an empty stomach. There are benefits of course to capsule formulation as not in a solid state and much quicker absorbed than by tablet.
Regards
Goodmorning Gumner68 , with regards to food phase trial l do not contemplate any requirement to continue to higher levels of dosing.
No need as basically looking at compound uptake not being compromised by food or certain foods that may have an effect.
Effectively it comes down to being is there a requirement to take the oral capsule on an empty stomach. Certain foods may slow or hinder uptake.
It may well be that the capsule may be administered on an empty stomach and 1 hr later you can have a meal.
It maybe that it is ok to take on a non empty stomach but my own personal opinion is this will not be the case. I may be wrong.
Regards.
SAD will the food phase of the trial continue with the MAD and do you know at what point it may finish ? Could this go on for another couple of months
TIA
Gla
Whoops forgot to add that 737 has a dosage therapy up to 800mg per day. Over 1000 mg per day up to 1300 mg toxicities started to become a problem
As l have said many times before l have never heard any news of problems of obtaining maximum tolerated dose of 737 at 30 times dosage with no adverse toxicities as has been the case with 1801.
1892 Sareum have to be careful whilst not wanting to rapidly progress 1802 due to burn up of cash availability for 1801 it will progrss albeit at a slower rate. Not necessarily a bad thing.
Regards and super weekend to all.
Data is of the upmost importance Gunner68. The data and nothing else will open the doors.
Are we safe to Use? Just how Safe? Faith in compounds.
Now if you remember the Sareum therapeutic data of treatment from 12.5mg per day upwards to 1000 mg per day.
737 had intended treatment range of up to 1000 mg per day. Over 1000 mg per day toxity approaching unacceptable ( not the correct term l will add). There was never any mention by Sareum in preclinical about 30 times treatment dosage being achieved with no undue toxicity with 737.
1801 had been used at 30 times dosaging regime with no toxicity concerns at all and were looking at 100 times, but as far as l know these levels were never attempted. Being able to supply enough of the compound was proving difficult at the time. A very similar problem with Aurora + FLT 4 being able to be supplied in sufficient capacities for clinical use and from whence a problem with solubility was encountered.
A problem for 1801 in thar there has never been a maximum tolerated dose established which is nearly a requirement to start clinical trials. 30 x the maximum dose can be taken but is not guaranteed. The Aussies chose a similar factor based on other similar jaki inhibitors and restricted this to approximate safety dosages to this regime.
With regards to a piddly 300 mg per day l am of the firm belief that all will bode very well on escalating safety dosing.
So much effort and attention to detail gone into
To our TYk2 Jak 1 compounds made of the patented protected molecules used to formulate these compounds l have the upmost faith.
Regards
Hi PCS Hassan and Pascal both seem like people who can muster interest and possible more funding looks like we just need the Data Data Date and hopefully we will take off from there .have a great weekend just waiting for the red dot to land now
GLA
Just how during how many here realised that Michelle Garrett was working as an advisor for Sierra Oncology.
Many of the recent reports with 737 is basically info nigh identical to research data carried out by M Garrett and Co. This looked at Wee1 and several other combinations with all the pluses and minuses.
Work was still being carried out up until mid 2020.
Good evening PC1954, it I nice to be back home, yes l am at Sizewell on the B site at the moment.
Looking forward to a beer or two if and when we take off.
Regards.
Hi Gunner
Interestingly, part of the conversation I had with Hassan at the AGM was regarding funding and one of the areas he mentioned was Saudi Arabia - only a snippet I know, but given the holding he oversees worth mentioning, step by step
Have a good weekend all and @ AugustDestiny, could be a very good moniker!!
GLA
Https://www.fiercebiotech.com/biotech/saudi-arabia-launches-plan-become-biotech-hub-2040
Maybe we should be looking at funding from this part of the world especially if 1801 comes up trumps
GLA
Great post August, a timely reminder of what were sitting on here , its hard at times but it will be worth it
Apols…this just came up on my twitter feed…again!
It appears that whilst we may appear to be in dire straits on the telegraph road, as D:Ream told us, things can only get better. Megadeath’s seventh album ;)
Https://x.com/edison_inv_res/status/1742576663190225271?s=46&t=_cUs6qcowyQbbF4MoPYSCw
Hi August it would be great to see movement on 1802 full stop as long as we see it going forward I’m sure would make everyone happy and add value to the SP hopefully being first in class ,interesting times ahead with 1801/737
GLA
News due soon for the single ascending dose (SAD) part of P1a should be completed now and data finalising, let's see if the bod capitalise on the opportunity and RNS to gain some attention.....
Sareum Holdings plc today announces Positive Topline P1 SAD Study Results for SDC-1801
Hi Gunner,
My understanding, from one of the presentations, I think it was Tim that mentioned that successful P1a progression of 1801 through the safety part of the trial , would negate the need for same with 1802 and that administration could proceed directly with patients . That’s my recollection, I stand open to correction though.