Member Info for sadoldgit

Some decent posts and contributions of thoughts today here on the whole.

No way will Sareum say they will licence at end of phase 1a. As stated by the board before they are looking to on licence at end of stage 1b.

If we look back close to 3 years ago Tim stated it was their objective to licence 1801 to raise the funds to develop 1802.

The number one problem exists as to funding. Sareum cannot continue on its present course of funding by the likes of sharks like RF. Disastrous!

However, has been stated by the board that interested parties are saying give us some data.

That data is in the process of being derived ie safety profile data plus biomarker data.

Without doubt the most important data is this safety date as that is required as a precursor to enable the selection of Indications that SDC1801 can treat, psoriasis being a minimum.

Various other Indications of potential can then be selected by the information of biomarkers.

This has a 2 pronged approach. Safety profile and efficacy are very closely correlated.

Many compounds can have efficacy in various Indications and when entered into clinical trial end objectives may or may not be met on efficacy but the down side is toxicity and off target side effects. That is it in a nut shell. Deucravacitinib is not as far as l am concerned ever going to make headway into UC.

Initial dosing strategy resulted in end points not being met. They were then evaluating higher dosaging but concerns as to compromising safety profile. Clearly pure allosteric Tyk2 is not in line with all the hype made by BMS.

Once a compound shows a promise in an indication and is granted to be used for treatment a company will look to commercialise it in other Indications. Some will work and many will not and that is why there are so many late failure stage results pointinting to poor statistical failure rates.

Correct me if l am wrong but l believe SDC1801 dose escalation taken up to 300mg per day.

Sareum originally stating that the treatment range would be up to a maximum of 1000 mg per day. Dosing in pre clinical gave no adverse effects up to 30 times treatment dosesge.

A nice problem to have said Tim but it may come back to bite us. We'll it did with the MHRA.

Back on course, now should the results of the clinical dose escalation data prove no adverse events then it will be game on. Our compound will then have a value. This value can then be significantly enhanced by clinical.data in an indication.

You are looking at approximately 3 to 5 times an increase in value by going from phase 1 success to either phase 2 or a phase 1b.

So at what point l ask does an interested party chose to become involved?

As the compound achieves milestones then so does the value go up significantly.

On top of this we have excellent long life patent protection, and a capsule as a method of oral administration. A capsule has significant advantages over tablet formation with regards to uptake of co

Https://www.grandviewresearch.com/industry-analysis/immunotherapy-drugs-market-report#:~:text=The%20global%20immunotherapy%20drugs%20market%20size%20was%20estimated%20at%20USD,USD%20117.46%20billion%20in%202022.

Https://www.pfizer.com/news/press-release/press-release-detail/roivant-and-pfizer-unveil-priovant-therapeutics-and-ongoing

A link below pertaining to Priovant indicating the rationale for on licence by Pfizer.

Looks very encouraging to say the least.

Regards to all.

Good evening PC1954.

I am back in Suffolk now for a while, much better than being a nearly 700 mile drive from home.

Just a few thoughts l have below.

Beprocitinib was discontinued by Pfizer in 2022.

As we know it is a Tyk2 Jak1 inhibitor it was sold to Priovant.

Pfizer had another inhibitor Ropsacitinib which they developed being a Tyk2 Jak2 inhibitor.

Results were good with regards efficacy but l suspect greater adverse effects due to Jak2 contribution. This was also discontinued and sold/licenced to Priovant.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9959504/

If we look in the above link and scroll well down to 4.5, SAR20347 gets a mention. Although preclinical results are encouraging to say the least and of course at the time of this report 20347 was not involved in any clinical trial.

My guess is that Sareum may well become involved with another player at around end of phase 1a. This being the safety profile and is of the upmost importance. It is imperative that this is established first.

With the addition of biomarker results pointing to Indications that 1801 has the most potential to maximise effectiveness and maintaining a satisfactory safety profile then this would surely be the beginning of an optimum time to either on licence or attract investment.

I am certain that Tim and Co have nailed the Tyk2 Jak1 compounds ensuring optimum safety. They would have an idea of Indications that 1801 being an immunotherapy can potentially treat.

The aim then will be to identify via the biomarker results albeit relatively low patient numbers the Indications that 1801 is likely to achieve best in class.

One thing l do know is the amount of difference in inhibitors including Tyk2 Jak1,

There is no such thing as pure specific with regards to Jak1, 2 and 3 only selectivity and getting these right is by no means an easy task due to safety profile. Allosteric Tyk2 is also not the be all and end all as Deucravacitinib failed to meet its end points in UC.

Tim and Co appear very confident in their Tyk2 Jak1 compounds.

What would we do if we were in Tim and Co's position?

These are my thoughts.

Clearly we have no idea as to what is going on in the background and any information regarding this will not be relayed as would lead to too much speculation. Any news on this l believe will be released as and when an agreement or agreements have been made.

Took advantage of a top up yesterday limited by the maximum amount that can have in my ISA

I have a feeling that in April the SP will be somewhat higher than now. May open an ISA to a family member and add to this year.

Regards

Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9959504/#:~:text=4.1.&text=Development%20of%20oral%20brepocitinib%20has,hidradenitis%20suppurativa%2C%20and%20Crohn's%20disease.

Https://www.nimbustx.com/2022/12/13/takeda-to-acquire-nimbus-therapeutics-highly-selective-allosteric-tyk2-inhibitor-to-address-multiple-immune-mediated-diseases/

A pertinent question here is, do Tyk2 Jak1 inhibitors have greater efficacy than allosteric Tyk2 alone.

I am sure we will out perform Deucravacitinib in plaque Psoriasis as we have dual approach.

Good afternoon Salfordred. Enjoy your tipple.

Relaxing to sit in font of nice fire too.

Myself, a day off work sorted the leak under kitchen sink and rodded all drains out. Pleased with result but not the aroma. Loads to do on house as been away most of the time over past 6 years.

Regards

Sfif.

Getting through this stage of the trial is of the most vital importance. Safety and toxicity results and bio marker Indications.

1801 will not be best in everything but just a couple of Indications to start off with will do.

Safety and toxicity are one of the most important aspects of a compound as it is that which limits the maximum amount that can be administered.

Later stage trials, drugs have been discontinued not because of their success in controlling a disease but due to the number of adverse effects with I creased dosaging.

Attention to detail is of the utmost importance from molecule selection, compound creation ,

compound purity, candidate selection, method of administration

Liberation

Absorption

Distribution

Metabolism

Excretion

Toxicity.

Cut corners on any of the above areas and you will not achieve best in class.

Many companies fail due to lack of attention at pre clinical stage.

Approx 10 years of development our SDC compounds so far.

As much as we can moan it has no effect on the ability of the compound being a success in its intended areas of treatment.

Enough from me.

Regards

How do you derive what is best in class?

Https://sareum.com/patents/

Https://www.lse.co.uk/rns/SAR/sareum-enhances-sdc-1801-patent-protection-6wj60w3rj5c40hr.html

True Potnak, but at this time Sierra was in the process of finalising trial design. Raising of finances was relatively easy but now in current economic climate, far from easy for an industry considered high risk.

Regards

Look through previous RNS's, the information is contained within.

Regards

Why did Sareum at the time need to raise in the €2.50 to £3.00 SP?

On hindsight it would have been better had they of done. But they had raised funds from HNWI's previously.

Who you going to replace Tim and Co with? How much you going to pay them?

News can come at any time on progress, we cannot force it.

Good morning PCS1954.

Lack of information as there is no information to give l feel. From a project point of view it is good to be kept up to date even if it is only nothing has changed and trials are progressing. I am not sure if this however would have a positive effect on the SP more likely negative.

With regards to 737 this is beyond the control of Sareum. The CPF will know who it is but for whatever reason this information not to be released at current time.

None of us are privy to what is going on in the background. Apart from interested parties needing to be shown data we have no idea.

I would hazard a guess at some sort of agreement after stage1 data safety profile and bio marker Indications. I am confident of an agreement most definitely at go ahead phase lb in Psoriasis.

Clearly we have a potential customer if we can call an interested party that, but at the same time they need to know what they are buying.

On thing Tim and Co will not do is release info that gives rise to speculation as you well remember from the days of the 'transformational deal.'

Sit tight is what l will do and l have added considerably over past few weeks.

There are new ideas and compounds that undergo development and enter the arena nigh every day in an ever increasing competitive field.

I am patient but at times my patience wears very thin.

Some sort of investment needs to be made by an interested party at around end of phase la results is my candid opinion.

I would not be surprised if Tim and Co are also of this mindset.

Regards

Apologies as intent was to put ,'could' instead of 'should". Bl00dy predictive text.

Regards

Tim snd Co have no control over world affairs which is causing recession and a very difficult financial market. 2 wars going on at the moment courtesy of the US. US 34 trillion dollars in debt.

UK in debt and so is the EU in debt. The bio pharma especially AIM listed suffer as a result.

You should take the opportunity to top up as l as well as others have done.

No good moaning as it is what it is at the moment. Trial progression is the top priority still irrespective of the very poor RF finance package.

Regards

I added too lutonnews. Sp is ridiculously low.

Sfif price drop nothing to do with trial progression.

Https://www.icr.ac.uk/news-archive/two-pronged-attack-on-dna-repair-could-kill-drug-resistant-cancers