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DewDiligence

11/18/15 9:48 AM

#197330 RE: ghmm #197321

Re: OCRX oral formulation (from Stifel webcast)

• Now deciding if moving forward with 1 or 2 (that look most promising of the 3) of the oral candidates to optimize and move forward with.

• Feel confidant have a BID formulation and possibly QD going forward.

Optimize formulation and repeat (phase 1) middle of next year.

This does seem like a rather slow jog for the oral formulation, which the company itself considers integral to the economic impetus for the overall HE program. However, after listening to the webcast replay this morning, I think the word, “optimize” means qD dosing rather than something more esoteric. Apparently, OCRX has decided that achieving qD dosing in the chronic setting justifies a 9-12 month delay in the development timeline; they may well be right in making this call.
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DewDiligence

11/18/15 12:26 PM

#197348 RE: ghmm #197321

Re: OCRX /Xifaxan combination therapy

One other noteworthy tidbit from OCRX's Stifel webcast is that OCRX thinks the STOP-HE trial will address the issue of whether OCR-002 works in combination with Xifaxan, and hence OCRX need not conduct combination studies per se.

Although STOP-HE does not require Xifaxan use, it permits Xifaxan to be used in the SoC arm at the discretion of the investigator. Given Xifaxan's popularity as an off-label treatment in acute HE, STOP-HE should thus produce an ample amount of data on patients who receive both drugs.