Replies to post #45381 on Innovation Pharmaceuticals Inc (IPIX)

[vip1999]

I think it is just a break down of Phase 2 to 2 different phases 2a and 2b.

Phase IIb: Well controlled trials to evaluate efficacy ( and safety) in patients with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine's efficacy.

[macnqueso]

In this case the P2b trial is clinically indicated because of findings in the P2a trial... namely that Brilacidin is highly effective in very short dosing protocols... and not really anymore effective in longer dosing protocols... and the possibility that shorter dosing cycle will further reduce any adverse side effects, which are already quite manageable, but less of this is even better... so before launching into a very expensive P3 trial designed to achieve stat sig level of efficacy... it makes sense to do a P2b with shorter dosing cycle as confirmation of P2a findings... data from P2b will inform the trial design for P3...

[BonelessCat]

Phase 2b trial is drug optimization using several test arms within the range of efficacy to optimize drug dosing and safety parameters. Phase 2/3 is an expanded trial that also seeks to optimize a drug, but safety and efficacy are better established so the trial also includes expansion of test subjects to elicit less common safety concerns such as allergenic responses and other downstream effects that need to be put on the label as well as to confirm safety parameters established in Phase 1 primary outcomes or Phase 2a if the trial is an expanded Phase 2b/3.

Seel can probably shed more light on this and correct any possible misconceptions in detail.