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YouTube·12 Aug 2020

Worth a look at the first couple of minutes. Need to Google.

I think you have pretty well nailed it Laz!

Regards

There are many compounds now in development for Psoriasis and it is indeed becoming very competitive.

However there have been very few developments on psoratic arthritis where treatments are required for many years to prevent serious debilitating decline that can lead to a life in a wheelchair.

This is still an area of urgent unmet need, as is SLE.

Long term safety of a drug is of the upmost paramount importance to treat these Indications.

As kinase inhibitors albeit early generation are approved for treatment of Indications such as RA, an advantage has to be gained in having a safety profile that betters them.

There are current form of treatment and you need to demonstrate a greater safety profile than current inhibitors have to gain any possibility of of removing them from the top of the current world market domination.

We will be happy if we do, but the pharmas that own them will be none to pleased.

That is a few years away.

Regards to all.

Compounds worth considerably more than our current market cap

A way off phase 2 completion, that being the stage reached on favourable safety data of Deucravacitinib whereby it was bought for 4 billion plus 2 billion on milestone payment payable on reaching certain commercial milestones.

It was not overly effective in Psoriasis.

So the associated safety profile of Deucravacitinib enhanced its value.

However it failed to reach its endpoints in Ulcerative Colitus.

We can't l believe put a value on SDC1801 as such apart from to say it has at the moment a potential to achieve a 4 billion subject to further long term safety data and by completion of phase2 clinical trial results in whatever indication or indications they are taken in.

Choosing to onlicence at the beginning of phase2 will significantly be of less value than phase 2 completion.

If we take a lowball risk valuation of 10% that still 400 million and to me that is on the very low side.

Call me a ramper l don't mind but there are investors now on board invested with considerable amounts of money.

All down to market sentiment.

I would much prefer to follow their actions than take notice of the continual repetitive negative bile posted on here by a few.

Funding has now been provided and it now is down to just how well our SDC1801 compound can perform.

Regards

Price is still low for what we have.

We are now funded to take us to the end of these further studies.

Institutions on board and funding from HNWI 's

Share price will creep up and of course traders will sell at times as well as buy back.

I don't honestly think that they will be buying back at these levels anymore.

Importance is to complete further investigations to enter phase2 trials.

Still cannot quite get head around these long term safety investigations.

Safety data is accumulated through all stages of clinical trial. Preclinical is only indicative as a precursor to clinical trial.

We are only at 300mg per day. No serious adverse events observed.

I am also of the opinion that we will be selecting St least one more indication possibly rheumatoid arthritis which there are other early jak inhibitors approved for use in this indication., albeit posing an acceptable level of myocardial adverse events

Is a pharma or Sareum trying to gain sufficient investigational data to indicate that SDC1801 is highly likely to be administered safely over a long periods of time with out any foreseeable adverse events in this area.

We are associated with the boxed warnings with the problems associated with early generation jak inhibitors,

Data supplied to us so far indicates a very favourable safety profile albeit not proven over substantial time frame or statistically significant number of patients

Just my views on this of course.

I have the upmost confidence in the ability to perform more favourable than any other Tyk2 and jaki compound out there at this moment in time.

The importance of long term patent protection provided by molecular make up and manufacturing thereof adds considerable patent protection to our SDC compounds.

Give Sareum credit where credit us due and realise the important commercialisation value that these patents add.

Institutional investors and High net worth individuals that have supplied funding will know at least a tad more than we do.

Onwards and upwards.

I will also add that data will be gained during the period of these further investigations as they progress.

Any interested party will want to be kept informed.

If more than one interested party as it appears will have an extremely positive outcome financially with regards to any licensing agreement.

Regards

Https://www.ft.com/content/51f5632a-b28e-4d46-9064-32944809dead

Good morning all.

Agree with you entirely that on the bases of non participation in phase1b that further work is required.

Phase 1b would have had people in clinical trial for a minum of 12 weeks and most likely 16 weeks plus. These are time frames for PASi score as targeting the PASI75 to be viable and indicate efficacy compared to other inhibitors.

These longer term dose regimes would give an indication with respect to long term safety.

Higher numbers are indeed more statistically significant.

Once phase 2 clinical trial application has been granted subject to the ability uo prove availability to obtain sufficient funding to cover trial cost then compound value rises drastically.

I would hazard a gues of minimum of 250 million up front with considerable milestones.

This is around an eighth of the price paid for Deucravacitinib at end of phase 2 with conclusive phase 2 data.

I would suggest that once phase 2 application has been submitted there will be a hefty rise North in the SP, in addition we may within a period allowing assessment by relevant bodies receive an offer to on licence or when the application has been granted, notice of on license to a company or the means by which Sareum have sufficient funding to cover clinical trial cost.

On satisfactory long term safety investigation conclusions then we sit in a very strong position, date l say the drivers seat.

Look at it it from a cool pa y that rushes to onlicence this.

They will play low ball for not knowing or been given data on the long term safety.

They can use this as a lever stick.

Once this hurdle is resolved, any foreseeable safety effects affecting the commercialisation viability is removed.

Regards.

Th

I am to an extent perplexed by the intent of further long term safety investigation in 1801.

Safety aspects are looked at all clinical trial phases and indeed after commercialisation.

Read the link below and see what you think.

Hiw do you establish long term safety in preclinical investigations when you are treating humans.

Yes more than 1 species is used in preclinical.

Dogs can be used as closer to humans biologically.

https://www.profil.com/knowledge-center/trial-stages

Interesting point but related to a above is an elevation in creatine levels associated with Tyk2

Yes Deucravacitinib is associated with.

However we detected no increase in creatine levels.

Early stage kinase inhibitors

Such as Baricitinib Jak 1 and Jak2 upadacitinib jak 1 selective have the dreaded boxed warnings.

Relating to such events tat give risk of blood clots and heart problems.

Our Phase 1a was with only a few patients.

Whist phase1 is basically to test the safety in a treatment, safety is also closely monitored in Phase 2, Phase 3 and post commercialisation.

Baricitinib for example whilst not giving info on long term safety here specifically is classed as safe to use in small doses for treatment lasting 6 and a half years.

To me yhe major concern here is to gain sufficient data to establish that we as a second generation more selective inhibitor have no prolonged usage concerns with regards to safety that have marred early 1st generation inhibitors.

Further studies will indeed go ahead and an RNS to released announcing aim objective and trial type and whether this is regarded as part of preclinical study if not carried out in humans.

Regards.

Good afternoon chrisatrdg.

It was not the RNS that we were expecting, certai ly not myself as looking at onlicence.

However, the RNS, apart from the delay to data package submission is all fine.

HNWI's along with institutions have raised 2.3 million.

This will enable the financing of the further studies.

I see no problems in our SD 1801 compound whatsoever

It is essential that we can supply all safety data that we have.

Long term use side effects can happen and are normally realised later in Phase 2 and phase 3 trials.

The only thing here in my opinion is a concern to long use of kinase inhibitors. We are talking about years here.how long can you effectively continual dose a patent for.

Psoriasis whilst at the moment not curable is treatable

In effect we are will be undertaking long term safety testing to reinforce the data that we already have in phase1a clinical.

Long term safety testing is not the same as a maximum tolerated dose or maximum therapeutic dose.

The importance here is that is comes down to the valuation of a the SDC1801 compound.

We may be able to continue treatment with a patient for 2 years 5 years or 10 years without any undue side effects.

So to establish long term use effects further testing is required.

We never obtained a maximum tolerated dose.

Indeed in the trial escalation daily dosing was restricted to 300mg per day.

This is 30% of the envisage maximum therapeutic dose.

This 30% applies to other kinase inhibitors and by the very nature of us containing a Jak1 however selective over we were subject to these restrictions.

All Jak1 Jak2 or Jak3 inhibitors irrespective of selectivity over have these restrictions placed upon them and in addition concern over long exposure to with associated negative effects.

In all we should be demonstrably safer than any jaki inhibitor with the exception possibly of Tyk2

If we are as good with regards to long term predictable safety that will make our compound commercially more viable from a financial point of view than Deucravacitinib.

Interested parties will want to know if we may be fit to be regarded ok for long term use.

They will commercialise, they can forecast number if patients and the effective time that the patient can remain on this compound whilst of course at the same time generating a revenue.

Yes, we may well prove to be good in other Indications such as SLE or Chohns Disease, type 1 diabetes, and many other Indications that require a lifetime of treatment.

The RNS to be taken as a good positive, irrespective of the time delay.

An institution has come aboard and for that to happen dialogue has happened to install confidence.

Regards

Https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death#:~:text=FDA%20is%20requiring%20new%20and,treat%20certain%20serious%20inflammatory%20conditions

The length of a phase 2 study can span several months to 2 years. This phase involves up to several hundred people, with researchers looking for the effectiveness and safety of the drug over a relatively short period of time.

The planned toxicology studies are designed to further validate the safety and tolerability of SDC-1801 over an extended period, providing essential data for regulatory submissions to conduct future clinical studies.

Nowhere in the RNS does it state that this is a requirement to progress to phase2 clinical trial

This funding, alongside a A$ 1.9 million (c. £1 million) tax credit received on 8th October 2024, from Australia for running the Phase 1 clinical development of the Company's lead candidate SDC-1801, will enable the Company to conduct further development of SDC-1801, including longer-term toxicology studies, to prepare the asset for Phase 2 clinical trials thereby enhancing its potential value.

Regards

I am inclined to agree with you there num4.

Long term toxicity effects that are associated with basically poorly selective first generation kinase inhibitors.

We are not pure Tyk2 as we know.

The question here would be how does your long term toxicity favour with allosteric tyk2.

Tyk2 carries no Black box warnings unlike conventional jak1, 2 and 3 inhibitors.

Talks clearly been taking place. Low ball offers in informal discussions also l feel.

The interested party will soon need to up the offer.

Regards

Riverfort were there to drag the company into financial failure.

The HNWI is an investor.

They will l believe know a tad more than us here.

Regards

Absolutely AndytheMkDon.

I would hazard a guess that subject to results we will have a licensing deal.

That is my opinion.

Onlicence at late preclinical or early clinical and that is where will be at phase2 ready.

An interesting point l will raise is for clinical trial the sponsor has to prove the ability to raise the sufficient funding.

With an on licensee this should not prove to be problematic as likely to have access to considerably more funding than Sareum.

I would think that this is Sareums main objective.

Phase 2 typically a couple of hundred patients.

Phase2a a few 10's

May l be so bold to suggest.

Application not been made yet but l have an idea the plan will be phase2 and not a phase2a.

2a is only a half measure but needs statistically significant numbers to give integrity to results

All.quiet on 737 front and news should be forthcoming soon

Regards

Hnwi contributors over 40 percent up.

Very pleasing for them and of course have options too.

Good morning prion

Deucravacitinib is one such inhibitor being allosteric Tyk2

'Bristol Myers Squibb - Sotyktu (deucravacitinib) Long-Term Data Demonstrate Durable Efficacy and Consistent Safety for up to Three Years in Moderate-to-Severe Plaque Psoriasis.'

That is just one inhibitor there are many others.

Safety profile needs to be comparable it may even exceed.

Deucravacitinib failed in Ulcerstive colitus

Any questions feel free to ask.

Regards

Goodmorning Celtic007

It takes a while to digest the RNS and have now read several times.

We have sufficient funding for long term toxicity tests.

This indicates to me that phase 2 clinical trial will be based over here.

Cardio toxicity is an important issue.

Nothing so far at these doses to affect kidneys.

We must also look at long term effects as long term use can rise to negative effects on the body.

Psoriasis is a long term treatment and in this instance long term treatment with such an inhibitor needs to clarify if there are likely problems to arise in sustained long term use.

Prexasertib ceased development due to myocardial toxicities.

It has since been taken on by another company.

From the data that is required it will determine if indeed we are to be best in class.

There are other inhibitors out there showing good results in safety and efficacy in Psoriasis.

An aimed 10% of 30 billion market cap is not to be sneezed at. Even 5% and if course other possible Indications such as SLE.

All part of placing a value on 1801.

HNWI invested 2 million.

They are not going to invest without knowing a tad more than we do.

Maybe they are subject to non disclosure,.

Overall a decent RNS the downside being of course will be a 3 to 4 month delay for data results.

So yes these results will be pivotal and as has been said before the HNWI will be privileged to more info than us here.

Regards

May well be looking at myocardiatoxicity.

May well benefit 1802 also as similar albeit similar but not exactly the same.

'Cardiotoxicity refers to any heart damage arising from cancer treatment. It isn’t common overall but may be common in people who take certain chemotherapy or targeted therapy drugs. You may also develop heart problems after having radiation therapy to the chest. Cardiotoxicity sometimes develops years after cancer treatment.'

Very prudent as many inhibitors carry differing degrees of this risk.

Regards.