Dear Shareholders,
You will hopefully have seen the publication, this month, of the full dataset from our Phase 1 clinical trial of SDC-1801 in the British Journal of Clinical Pharmacology [1] , one of the most respected peer-reviewed scientific journals in its field. Publication in a peer-reviewed journal validates our confidence in the tolerability and pharmacokinetic profile of this molecule and offers a strong signal of potential efficacy.
Most importantly, in all doses tested, from 5mg up to 150mg, SDC-1801 was shown to be safe and well tolerated. There were no deaths and no serious side effects that could be attributed to the drug, reinforcing our confidence in the safety profile.
Pharmacokinetics analysis confirmed that SDC-1801 has a half-life of approximately 15 to 27 hours. In practical terms, this means the drug stays active in the body long enough to support once-daily dosing. This is an important advantage, as simpler dosing regimens improve patient adherence to treatment.
One of the most striking findings was that SDC-1801, at a dose of 70mg twice daily, achieved blood levels comparable to those seen with brepocitinib at its 100mg once-daily dose. Crucially, SDC-1801 achieved this without the side effects that have been observed with brepocitinib at equivalent exposure levels. The comparison with brepocitinib is particularly noteworthy. It suggests that, when compared to existing therapies, SDC-1801 may offer patients a cleaner, more tolerable option in a proven therapeutic class. That is a compelling proposition, and it reinforces my conviction that SDC-1801 has genuine best-in-class potential.
Biomarker analysis provided clear evidence that SDC-1801 is doing what it is designed to do: engaging TYK2 and JAK1 in a sustained and dose-dependent way. Reductions in established inflammatory biomarkers are a strong signal of potential efficacy in patients with autoimmune conditions.
The publication of the full dataset supports our confidence in our clinical programme for SDC-1801. We are now focused on completing the work needed to take SDC-1801 into Phase 2 and are making good progress with toxicology studies, which are on track to complete dosing by the end of July. We anticipate having a complete regulatory package for progression to Phase 2 in place by the end of this year.
Meanwhile, we continue to make good progress with our business development discussions focused on SRA737, building on the positive Phase 1/2 data that demonstrated good tolerability as monotherapy and promising activity in combination with low-dose gemcitabine in anogenital cancers.
As we approach the second half of the year, we remain confident in the prospects for our lead asset and excited about the benefits we believe we can bring to patients and investors.
As always, thank you for your continued support.
Stephen Parker,
Executive Chairman,
Sareum Holdings plc
[1] The full scientific paper is available via the British Journal of Clinical Pharmacology at bpspubs.onlinelibrary.wiley.com. For investor enquiries, please contact ir@sareum.co.uk.