Daily Newsletter

05 September 2023

Daily Newsletter

05 September 2023

Sareum doses first subjects in second stage of Phase 1a trial of SDC-1801

Full safety data from the Phase Ia trial are anticipated in the first half of next year.

September 05 2023

Sareum has dosed the first subjects in the multiple ascending dose section of a Phase Ia clinical trial of SDC-1801 to treat autoimmune diseases.

Subjects in the second stage will receive oral SDC-1801 once daily for ten days at a specialist clinical unit in Melbourne, Australia.

The latest move to progress to the next dose group comes after the safety review committee granted approval following its review of preliminary data generated from the initial three cohorts in the single ascending dose section of the study.

The data further supports the continuation of the dose escalation from the first part of the study.

A favourable profile of SDC-1801 was also demonstrated based on the safety and pharmacokinetics data from the initial cohorts in part one.

Sareum CEO Dr Tim Mitchell said: “During this next phase of the study, we expect valuable biomarker data to be generated that will be available upon completion of this part of the trial.

“As SDC-1801 continues to progress through the clinic on schedule, we remain committed to bringing this innovative medicine to patients with autoimmune disease.

“We look forward to the completion of the Phase Ia study and to progression into Phase Ib, subject to continuing positive safety results in the remainder of the Phase Ia.”

Full safety results from the Phase Ia trial are anticipated in the first half of next year while a Phase Ib study is expected to initiate soon for treating psoriasis patients.

In addition to parts one and two of the study, the randomised, placebo-controlled Phase Ia clinical trial will investigate the food effects of SDC-1801 in part three of the study.

M&A in the Contract Manufacturing Industry

Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.

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