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Phase 1 trials could be seen as the most important for adding value? Next news .. trial excepted or Q3 GSK SAR 737.. Come on SAR
Hopefully a settlement???
Reminder from recent RNS:
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.
Reminder from resent RNS:
Shocking share price??? I say it again I should have took 10p a year ago.. There has been so much progress since then! is it being shorted- PH holding the reins let it go
THE BIT I LIKE £30 billion MARKET
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum submits Clinical Trial Authorisation application to UK MHRA for development of TYK2/JAK1 inhibitor SDC-1801 and provides an Operational Update
á Clinical Trial Authorisation application for a Phase 1a/b clinical trial with SDC-1801 submitted to the UK Medicines and Healthcare Products Regulatory Agency
á Sareum has made significant progress advancing SDC-1801 towards clinical development and plans to initiate Phase 1 clinical trials in 2022, with a study in psoriasis targeted for 2023
á The Company continues to progress translational studies to support its cancer immunotherapy candidate, SDC-1802
á New EU patent granted (April 2022), protecting the SDC-1802 molecule and pharmaceutical preparations as a therapeutic to treat T-cell acute lymphoblastic leukaemia
á Sareum had a cash position of approximately £4.3 million as at 30 June 2022
á A presentation to investors will take place on 4 August 2022 at 10.00am via the Investor Meet Company platform. See below for registration details.
Cambridge, UK, 28 July 2022 Ð Sareum Holdings plc (AIM: SAR), the specialist drug development company, today announces that it has submitted an application for a Clinical Trial Authorisation ("CTA") to the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") for the development of SDC-1801 as a potential new therapeutic for a range of autoimmune diseases with a focus on psoriasis.
Sareum also provides a broader update on operational activities and pipeline progress.
OPERATIONAL HIGHLIGHTS - STRONG PIPELINE PROGRESS
SDC-1801 (autoimmune disease)
SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin.
Preclinical development activities required to apply for the CTA have been successfully concluded and, consistent with the Company's clinical development plan, an application for a CTA has now been filed.
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.
Sareum, working alongside a specialist contract research organisation (CRO), has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to regulatory approval from MHRA, the Phase 1a trial is planned to commence in Q4 2022 and will investigate the safety and tolerability of an oral formulation of SDC-1801 in ascending doses administered to healthy subjects. In addition, the trial will evalua
RNS has landed
Had a little read through previous posts hopefully 737 we be updated via GSK Q2 Wednesday 27th this should be the catalyst needed for mass investment is SAR.. come On SAR/GlaxoSmithKline!
I still believe the only way of preventing future pandemics is having a home test that is fast and easy to use. I quick test by the front door in every house hold before you go out into the plague infested world will more that likely prevent the world becoming infested in the first place let’s hope to a brighter future not a zombie apocalypse.. this is new technology I’m happy to stay invested
I am ready for the big bucks 2
A nice cosy partnership with GSK would be lovely 11am RNS oncoming ????
The graphene age is starting and CPX is right in the mix.. it’s a no brainier it’s time to load up gla.. this is going to get very interesting very quickly imho
Any one for space invaders???
CPX had an interesting RNS this morning worth A read.. before a pouncing I’m just sharing the love xx
It’s time to load up?? smile everyone CPX is going to be a Titan!!!! Good luck long term holders
Still holding and hoping but not knowing
For those whom think they are clairvoyant and for those whom simply need a recap please read as this is what’s going on obviously dah x
Wed, 16th Mar 2022 07:00
RNS Number : 8792E
Sareum Holdings PLC
16 March 2022
Sareum Holdings plc
("Sareum" or the "Company")
SDC-1801 on Track to Enter Clinical Development in H2 2022 following Positive Preclinical Data Analysis and Toxicology Report
Cambridge, UK, 16 March 2022 - Sareum Holdings plc (AIM: SAR), the specialist drug development company, is pleased to provide an update on the development of its proprietary TYK2/JAK1 inhibitor SDC-1801 towards first-in-human trials. As disclosed in the Company's half-year results on 21 February 2022, the data analysis from the preclinical toxicology and safety studies required to file for an exploratory Clinical Trial Authorisation ("CTA") is complete. The Company has now received the final signed report from the Contract Research Organisation that conducted these studies and, as previously reported, these data fully support the Company's plan to submit a CTA application in mid-2022 and to commence a Phase 1a clinical trial with SDC-1801 in H2 2022.
SDC-1801 is being developed as a potential new treatment for a range of autoimmune diseases and for the acute respiratory symptoms of Covid-19.
The report confirms that the studies met their objectives of identifying any organs or tissues that might be susceptible to high-dose toxicity and determining an appropriate dose range to test in first-in-human studies.
Sareum is working with specialist clinical trial consultants to design the first clinical trial with SDC-1801. This Phase 1a trial will investigate the safety of ascending doses of SDC-1801 in healthy subjects prior to the selection of an initial indication for further clinical study in patients in any subsequent trials. The Phase 1a trial will also investigate the effect of SDC-1801 on certain biomarkers of autoimmune disease that could be predictive of efficacy when tested in patients.
In addition, the manufacture of SDC-1801 drug substance and oral capsule formulation under Good Manufacturing Practice ("GMP") conditions is on track to enable the Phase 1a trial to commence in H2 2022, pending their successful completion and the requisite CTA approval.
Dr John Reader, Chief Scientific Officer of Sareum, commented: "We are pleased to have successfully completed the preclinical toxicology studies and have now received the final report, which will form a key part of the planned CTA application for SDC-1801. We are particularly encouraged that the promising data and progress with the manufacture of SDC-1801 in capsule form continue to support our intention to file the CTA application in mid-year and our plan to begin the first clinical trial with SDC-1801 during H2 2022."
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO
Hopefully SAR are inline to partner GSK as Roivant with Pfizer? Roivant have a MC of 3 billion it would be fantastic if SAR could be valued the same? obviously gla..
Sooner the better as far as research and commercialisation are concerned
Still the great silence grows??? I’m thinking the next noise made form the BOD will be extremely load! Come on SAR ITS TIME TO SHINE GLA
We are now licensed to GSK lovely jubbly.. maybe a champagne moment??? GLA