(Sharecast News) - Sareum announced significant milestones in its phase 1a clinical trial for SDC-1801, its lead programme aimed at addressing autoimmune diseases such as psoriasis, on Thursday.
The AIM-traded firm said the completion of the single ascending dose (SAD) phase and the food effect study marked progress in the development of the dual TYK2/JAK1 kinase inhibitor.
It said the phase 1a trial focussed on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of SDC-1801 in healthy subjects.
Comprising single and multiple ascending dose studies, as well as a food effects study, the trial aimed to provide crucial insights into the therapeutic potential of SDC-1801.
Following the dosing of the final subjects in the SAD phase, preliminary data analysis revealed promising results.
The safety review committee's assessment indicated a favourable safety profile for SDC-1801, supporting its potential for once-daily oral dosing.
No serious adverse events were reported, suggesting the compound's safety and tolerability.
Additionally, the completion of the food effect study demonstrated that SDC-1801's blood levels remained consistent regardless of food intake.
That finding offered flexibility in dosing schedules for future clinical studies, enhancing the drug's usability and convenience.
While the multiple ascending dose study was ongoing, the company said it anticipated the availability of full safety data in the first half of 2024.
Pending satisfactory results and contingent on financing, regulatory approvals and recruitment, Sareum said it was planning to initiate a phase 1b clinical study.
The next phase aimed to enrol up to 24 psoriasis patients, with completion expected by the end of 2024.
"We're pleased to announce that Sareum has cleared an important milestone in this trial," said chief executive officer Dr Tim Mitchell.
"We are encouraged by the preliminary data from the SAD and food effect parts of the phase 1a trial for SDC-1801, which support our confidence in the trial and the broader clinical strategy."
Dr Mitchell said while they were preliminary results, if the firm continued to see the positive safety profile and pharmacokinetic data seen so far, that would underpin our planning for the phase 1b part of the study and beyond.
"We look forward to the data from the multiple ascending dose part of this trial, which will help us advance towards this critical next point in the study."
At 1257 GMT, shares in Sareum Holdings were up 11.73% at 41.9p.
Reporting by Josh White for Sharecast.com.
Sareum (SAR)