Hi all,
A new SNT 6302. I didn't expect that ! But it must be a really top product as SNT 6302 was and is world class.
From a scientific perspective this is what stood out for me. Why do a placebo wing in a Phase 1b?
Phase 1b trials with a placebo wing are conducted for several important reasons:
Safety assessment: While the primary focus of Phase 1 trials is safety, including a placebo group allows researchers to distinguish between adverse events caused by the investigational drug and those that may occur naturally or due to the underlying condition.
Dose-finding: Phase 1b trials often involve dose escalation to determine the optimal dose for future studies. A placebo group helps researchers compare the effects of different doses to a baseline.
Preliminary efficacy signals: Although not the main objective, a placebo group can provide early indications of potential efficacy, which can inform the design of subsequent Phase 2 trials.
Reduction of bias: Placebo controls help reduce bias in both participants and researchers, ensuring that observed effects are truly due to the investigational drug.
Pharmacodynamic profiling: Comparing the drug's effects to placebo allows researchers to better understand the pharmacodynamic properties of the investigational product.
Ethical considerations: In some cases, especially for serious conditions with no effective treatments, including a placebo group in early-phase trials can be more ethically acceptable than in later-phase studies.
So read between the lines this is more akin to how a Phase 2 is run.
Will it fast track time to getting to a Phase 3 , one could deduce yes as early objectives are completed.
Well done Scientific Officer and ancillary team.
I wish other Companies were this accomplished.
Kpax
(20min delay)