It's all in the timing?22 Jun 2026 14:59
Whilst the publication ties in nicely with the start of the Bio Convention, has anyone else considered the choice of date MIGHT also be a solid indication that the tox study results (as far as they can be known), are top notch? The manuscript was finally accepted on 27th May so the BoD could have paid the open-access publication fee back then but they appear to have waited. Was it to give them the option of waiting for preliminary results of the tox study and if things looked bad, they could say stuff the publication fee and focus on 737?
Having read the paper, the only major thing that leaps out to me as a potential issue (keep in mind I'm neither doctor or scientist), is "Sporadic cases of myalgia and rhabdomyolysis have also been observed with other JAK and TYK2 inhibitors underscoring the importance of continued surveillance for potential muscle toxicity in the early clinical development of SDC-1801."
(Rhabdomyolysis is a serious condition characterized by the breakdown of muscle tissue, leading to the release of harmful substances into the bloodstream, which can cause kidney damage. Symptoms include muscle pain, weakness, and dark-colored urine.)
The study notes, "One participant in the 100 mg OD SDC-1801 cohort had an elevated creatine phosphokinase (CPK) level of 237 U/l on day 6 of treatment and on directed questioning complained of mild low back pain; CPK rose to 9606 U/l by day 9. CPK decreased progressively and was within the normal range at the follow-up visit (day 24). Moderate rhabdomyolysis was diagnosed on day 6 and mild myalgia on day 8, which resolved on day 10. Both were considered probably related to SDC-1801, and the participant was withdrawn from treatment on day 9."
So it looks like keeping dosing to below 100mg should be safe.
The other point of interest for me was, "Administration of SDC-1801 over the dosing ranges was performed with differing combinations of SDC-1801 capsule strengths, and inspection of the SDC-1801 concentration time curves for each of the doses indicated that the 50 mg capsules delivered much lower SDC-1801 exposure than expected, exemplified by the 100 mg OD dose (Figure 3B). To better understand exposure related to the 50 mg capsule, an alternative capsule configuration was used in the 75 mg OD and 70 mg BID cohorts, replacing the 50 mg capsule with 5 × 10 mg capsules; it was clear that the 10 mg capsules provided better exposure than the 50 mg capsule." I'm in no doubt the anomaly can be addressed.
Regards.
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