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AZRX: Update on MS1819 Phase II Trial

By John Vandermosten, CFA


AzurRx BioPharma, Inc. (NASDAQ:AZRX) announced an update to their Phase IIa Trial outcomes for MS1819.  The company announced interim results for the first six patients of an anticipated 12 – 15 patient study showing a positive dose response curve and a 21% improvement in the coefficient of fat absorption (CFA) in evaluable patients.  The response rate went as high as 57% in one of the patients observed, and higher response rates were noted in patients with lower baseline CFA levels.

Secondary endpoints including Bristol Stool Scale, number of daily evacuations, and weight of stool were similarly improved as CFA.  From a safety standpoint, no serious adverse events, or notable mild or moderate events have occurred in the trial.  

AzurRx did not provide any updates on additional enrollees beyond the six cited in the interim update, however, we expect updated data when the company completes the trial.  Company commentary has indicated they are adding about one patient per month.  Acknowledging the two week washout period and two months of dose cohorts, patient analysis takes about 2.5 months which suggests we could see Phase IIa results in the first half of 2018.

We see today’s data update as expected and supportive of our positive thesis on AzurRx.  

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