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Research: Healthcare
Sareum Holdings has announced positive top-line data from the Phase Ia clinical trial for SDC-1801, its lead asset, a novel TYK2/JAK1 inhibitor targeting autoimmune conditions. The results, which include data from the multiple ascending dose (MAD) arm, reiterate the drug-supportive safety profile and once-daily dosing potential, complementing the preliminary data released in February 2024. Notably, no significant change in serum creatinine levels (which tends to affect kidney function) was observed in SDC-1801 treatment, a potential limitation of the TYK2/JAK1 inhibitor category leader, brepocitinib, as seen in several clinical trials. Full, unblinded data from the Phase I study will be available in Q324 and will potentially be followed by a Phase IIa study in psoriasis patients.
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Sareum Holdings |
SDC-1801 records positive Phase Ia data
Pharma and biotech |
Spotlight - Flash
2 July 2024 |
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Sareum Holdings is a research client of Edison Investment Research Limited |
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Sareum Holdings has announced positive top-line data from the Phase Ia clinical trial for SDC-1801, its lead asset, a novel TYK2/JAK1 inhibitor targeting autoimmune conditions. The results, which include data from the multiple ascending dose (MAD) arm, reiterate the drug-supportive safety profile and once-daily dosing potential, complementing the preliminary data released in February 2024. Notably, no significant change in serum creatinine levels (which tends to affect kidney function) was observed in SDC-1801 treatment, a potential limitation of the TYK2/JAK1 inhibitor category leader, brepocitinib, as seen in several clinical trials. Full, unblinded data from the Phase I study will be available in Q324 and will potentially be followed by a Phase IIa study in psoriasis patients.
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Source: Company data. Note: *EPS figures have been adjusted retrospectively for the 50:1 share consolidation in March 2022. |
Sareum has reported encouraging top-line data from the Phase Ia study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of SDC-1801 in healthy volunteers. This includes new data from the MAD arm (four sequential and ascending doses tested for 10 days on four dose cohorts with eight participants each), which recently concluded healthy volunteer dosing, although the observations remain blinded for now. Preliminary data from the single ascending dose and food effect arms was shared in February 2024 and the latest observations are in line with the previously shared information. The drug continued to show a strong safety profile, with no serious adverse events or deaths. Moreover, management noted that SDC-1801 was able to achieve materially higher exposure in blood than predicted therapeutic levels, with a relatively long half-life (17–20 hours), which supports the previously observed potential of restricting the treatment to once-daily dosing (similar to FDA-approved TYK2 inhibitor Sotyktu). Importantly, no significant changes to the blood counts or increased serum creatinine levels were observed, a potential advantage over Pfizer/Roivant Sciences’ brepocitinib (the most clinically advanced Phase III TYK2/JAK1 asset), which has recorded higher creatinine levels across multiple trials.
Full, unblinded data from the study are expected to be available in Q324, with biomarker data and further details on the safety profile and comparison across the drug/placebo cohorts. We expect this to be followed by a Phase IIa study in psoriasis patients, although the timing will be contingent on the company’s success in securing external capital (either through a development partner or an equity raise). As indicated in our previous note, the current cash at hand (c £3.2m, including £0.4m gross cash at end-H124, £0.4m in R&D tax credit received in Q1 CY24, the £2.3m equity raise in March 2024 and £0.1m from warrants exercise) provides a runway into H224, but we expect additional funds will be required to initiate and run the Phase IIa study.
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Research: Real Estate
Target Healthcare REIT has sold four of its care homes for £44.5m to the incumbent tenant, modestly ahead of the carried value. The homes have performed well since being acquired as part of the significant portfolio transaction in late 2021, but their sale enhances key portfolio average metrics such as age, floor space and unexpired lease term, has been completed at a lower yield than the portfolio average and enables the company to reduce exposure to more expensive debt.