RE: RE: CTA application SDC180127 May 2022 13:26
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.
it's all there in black and white for everyone that DYOR
H2 is the time line, meaning half year June, give or take a day or two,
and with only 3 trading days to go after today, I'm looking forward to an early
RNS update, in that regards, if the 1801 TOX report is anything to go by, that was 3 weeks earlier
than expected..
BTW yet another full blue day of buying?? sentiment is slowly changing at SAR
and I'm sure MM will start taking the brakes off at some point
if not today 1 day next week..
ATB
308..