Sareum has announced that it has filed a clinical trial authorisation (CTA) application for its lead asset, SDC-1801, with the UK Medicines and Healthcare products Regulatory Agency. The announcement marks a key milestone for the company and paves the way for the clinical transition of its flagship TYK2/JAK1 inhibitor targeting the autoimmune space. Subject to regulatory approval, the Phase Ia trial is expected to start in Q4 CY22 and will evaluate the safety and tolerability of SDC-1801 in healthy subjects. If successful, Sareum will initiate a Phase Ib study in psoriasis (PS) patients in 2023. The £4.3m cash balance at the end of June should be sufficient to take SDC-1801 through Phase Ia clinical trials, with the company continuing to assess funding options to further clinical development.
29 Jul 2022
Sareum Holdings - SDC-1801 CTA filed in the UK
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Sareum Holdings - SDC-1801 CTA filed in the UK
Sareum Holdings plc (SAR:LON) | 27.5 -0.8 (-9.8%) | Mkt Cap: 28.8m
- Published:
29 Jul 2022 -
Author:
Soo Romanoff -
Pages:
2
Sareum has announced that it has filed a clinical trial authorisation (CTA) application for its lead asset, SDC-1801, with the UK Medicines and Healthcare products Regulatory Agency. The announcement marks a key milestone for the company and paves the way for the clinical transition of its flagship TYK2/JAK1 inhibitor targeting the autoimmune space. Subject to regulatory approval, the Phase Ia trial is expected to start in Q4 CY22 and will evaluate the safety and tolerability of SDC-1801 in healthy subjects. If successful, Sareum will initiate a Phase Ib study in psoriasis (PS) patients in 2023. The £4.3m cash balance at the end of June should be sufficient to take SDC-1801 through Phase Ia clinical trials, with the company continuing to assess funding options to further clinical development.