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Sareum hails safety profile for SDC-1801 after phase 1 trial

Thu, 15th Feb 2024 11:20

(Alliance News) - Sareum Holdings PLC on Thursday said SDC-1801 has the potential to achieve therapeutically effective dose levels with no serious adverse events, following a phase 1 trial.

Shares in Sareum rose 7.3% to 40.25 pence each in London on Thursday morning.

The Cambridge, England-based pharmaceutical company, which completed the single ascending dose part of a phase 1a clinical trial for SDC-1801, said the study indicated a "favourable profile" and supported the oral dosing of psoriasis patients once a day.

SDC-1801 is a dual TYK2/JAK1 kinase inhibitor, which is 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.

Sareum said the study is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. This trial includes a single ascending dose study, a multiple ascending dose study and a food effects study.

The food effect study part of the trial has also been completed, the firm said, demonstrating no significant food effect on SDC-1801 blood levels.

The multiple ascending dose study is ongoing and full safety data from the Phase 1a clinical trial are expected to be available during the first half of 2024, the company said.

If the results are satisfactory and subject to financing, regulatory requirements, and recruitment preparations, the company will initiate a phase 1b clinical study. It said it would aim to recruit up to 24 psoriasis patients, and have the study completed by the end of 2024.

Chief Executive Officer Tim Mitchell said: "We're pleased to announce that Sareum has cleared an important milestone in this trial. 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.

"These are preliminary results but if we continue to see the positive safety profile and pharmacokinetic data we have seen so far, this will 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."

By Sabrina Penty, Alliance News reporter

Comments and questions to newsroom@alliancenews.com

Copyright 2024 Alliance News Ltd. All Rights Reserved.

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