RE: A simple AI explanation…..28 Apr 2026 16:09
Hi PCS/BenH et al -
IMC meeting 29th Oct 2024 -
Question 1: Can you provide more detail on the proposed 1801 tox studies e.g. will they be in humans, animals or utilise AI, will the trials remain in Australia and what timescale is required?
The aim is to get the SDC-1801 programme Phase 2 ready, and depending on the disease we’ll initially study in Phase 2, we’d expect to get a readout in 12 to 16 weeks. We'd like to give ourselves the option to be able to dose for up to 16 weeks in patients, and in order to do that, you have to have preclinical tox studies in two species for a minimum of 16 weeks. This is a regulatory requirement. As far as we are aware, no regulatory authority will accept AI derived results for example.
Regarding trials remaining in Australia, if we or a partner company proceeds to Phase 2, groups of 40-60 patients will be required, so these are usually conducted in multi-centre sites across several different countries, of which Australia may well be one.
Question 5:
Can you elaborate if there were specific toxicology concerns that emerged during the 1a trial which prompted the decision to extend the toxicology studies? What were the key findings or observations that led to this course of action?
There were no toxicity concerns raised from the Phase 1 trial so the decision to look at extended preclinical toxicities is purely based on regulatory requirement to be able to move ahead and conduct a Phase 2 study. Feedback from potential commercialisation partners was that they didn't see the benefit of a short validating Phase 1b trial because the TYK2 target is now clinically validated, and saw more benefits in taking the programme straight into Phase 2 trials. We are therefore going to get the programme Phase 2 ready for positive reasons rather than any negative reasons arising from the Phase 1 trial.
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