On May 20th AzurRx BioPharma, Inc. (NASDAQ:AZRX) presented secondary endpoint results for its Phase II Chronic Pancreatitis (CP) study, which completed clinical work in June 2018. The update follows topline and primary endpoint results released from the same trial last fall, which found a coefficient of fat absorption of 21.8% statistically significant to a p value of 0.002. We discussed these results in a September 2018 article.
View Exhibit I – Phase 2a CP Trial Design
The MS1819-SD Phase 2a open-label, dose escalation study was conducted in France, Australia and New Zealand. Secondary endpoints included stool consistency, bowel movements per day, steatorrhea and abdominal discomfort using a visual analog scale). All of the metrics moved in the right direction, with stool consistency, bowel movements and steatorrhea mean change all reaching statistically significant levels.
We provided an in depth discussion of the primary endpoint, coefficient of fat absorption, in the previous report referenced above, which was provided for reference in the company release. Observations compare results from baseline against results at the highest 2240 mg dose for the endpoints provided. Stool consistency improved by 20% on the Bristol scale, from a baseline of 5.1 to 4.1, with a p value of <0.001. Bowel movements were reduced by almost one per day, as daily evacuations decreased by 32%, from a baseline of 2.8 to 1.9 per day, with a p value of 0.006. The presence of excess fat in the feces (steatorrhea) was reduced by 18%, from 12.3 to 10.1, with a p value of 0.008. Abdominal discomfort was also better, but it was not statistically significant for the population observed. Below we provide the summary of data from the chronic pancreatitis study for MS1819-SD.
View Exhibit II – Summary of Endpoint Values for CP Study
A total of ten patients completed the trial, out of a screened 62. We note the high rate of attrition from screening; 39 of the screened individuals did not meet the inclusion/exclusion criteria, while another 3 withdrew consent and one had an adverse event. Eight others had other undisclosed reasons for not participating. This left 11 to be enrolled in the study, of which one dropped out, leaving 10 completers.
Four of eleven patients had at least one drug related adverse event. The most common adverse events were gastrointestinal disorders (4) and abdominal pain (2). The study investigators have found that the drug is safe and well tolerated up to the highest dose of 2240 mg/day.
The Phase IIa CP study primary and secondary endpoints show that MS1819-SD has a statistically significant benefit. The best outcomes were observed in patients at the highest dose and who presented a baseline CFA of less than 40 or taking proton pump inhibitor (PPI) therapy.
The focus of the latest release was to highlight the benefits observed in the secondary endpoints, including stool consistency, bowel movements and steatorrhea. These favorable changes can significantly impact the quality of life for patients justifying the utility of the recombinant lipase. AzurRx is currently conducting a Phase IIb trial in about 30 patients with EPI brought about by cystic fibrosis. The company just announced full enrollment in the trial and we anticipate topline results to be announced by summer 2019.
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