Biotech Values

[DewDiligence]

OCRX—I’m not concerned about OCR-002’s efficacy per se, but rather about the phase-2b trial design in HE where OCRX has modeled a 23% improvement for OCR_002 + SoC relative to SoC alone. The problem here is that the SoC, a laxative detested by patents and hospital staff, actually world fairly well, so showing an incremental statsig improvement by adding OCR-002 may be tough.

If it were strictly up to me, the goal of the phase-2b trial would be to show non-inferiority relative to the SOC on efficacy (removal of ammonia) and superiority relative to the SoC on some composite measure of patient and hospital-staff satisfaction. Of course, the FDA would be unlikely to agree to such a design in phase-3, which is why OCRX isn’t using such a design.

In any case, the phase-2b trial is expected to have a futility and enrollment-size analysis any day, and is expected to report final data by late 2015 (subject to a robust enrollment rate).