Replies to post #245072 on Biotech Values

[DewDiligence]

Re: EDP-235 phase-2 design

Looks like they are picking patients who are in pretty good shape.

They are. The EDP-235 phase-2 trial is too small to have sufficient statistical power for such metrics as the rate of hospitalization; rather, the purpose of the phase-2 is to gather more evidence on safety and viral loads and to select a dose (or doses) for phase-3. In phase-3, the tested population will almost certainly include high-risk patients.

Since the phase-2 trial does not intend to show a statsig reduction in the rate of hospitalization, enrolling average-risk patients will not cause the trial to fail statistically. What it will do is speed up recruitment and thereby shorten the time to the onset of phase-3.

[Biowatch]

Typically clinical trials enroll the healthiest of the potentially ill because they don’t want outside factors to “confuse” the data.

If for example someone is already coming down with Covid, or may be at extreme risk of adverse consequences if they have Covid, they probably don’t want them in the trial because it will make the adverse effects or poor outcomes look worse.

For example, if someone is at very high risk of a lethal heart attack before they enroll in the trial, if they die of a heart attack during the trial, that will be counted as an adverse event due to the trial, not as something that would have happened regardless of their enrollment.