Biotech Values

[DewDiligence]

Re: Intranasal Byetta / AMLN NSTK

>I understand why clinical trials take so long when switching from daily (Byetta) to weekly (LAR). But if intranasal would also be given daily, and the safety/efficacy of Exenatide have already been established with Byetta, does there really need to be a "full" phase I trial? I would have thought that something as simple as a head-to-head test between Byetta injection and Exenatide intranasal to see if efficacy remained the same would almost be a "Phase II" trial. Sorry if that's a dopey question.<

First of all, it’s not at all a dopey question—it’s a good one.

Intranasal (IN) Byetta uses proprietary excipients from NSTK to open the “tight junctions” in the nasal mucosa. A phase-1 study is needed not only to test dosing and pharmacokinetics but also to assure that there is no nose-specific toxicity.

An unanswered question is whether IN Byetta will be able to proceed using a 505b2 regulatory pathway as an alternative formulation of Byetta, or whether it will proceed under a regular BLA pathway as a distinct chemical entity. If the former, then the kind of head-to-head study you suggested might be allowed as a single phase-3 pivotal trial, to be preceded by some kind of phase-2 trial to further refine dosing.

Listen carefully for any mention by AMLN of “505b2” with respect to the IN Byetta program; if you hear the magic word, it may not be unreasonable to think that IN Byetta could make it to market before Exenatide LAR.