AzurRx BioPharma, Inc. (NASDAQ:AZRX) (AzurRx or the Company), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced, in partnership with Mayoly Spindler, a European pharmaceutical company, the completion of its Phase IIa trial of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis. AzurRx expects to formally report the Phase IIa data in the Fall of 2018.
The primary objective of the open-label, multi-center, dose escalation Phase IIa study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the CFA (coefficient of fat absorption) and its change from baseline.
Initial data from the Phase IIa study shows a very strong safety and efficacy profile. Both clinical activity and a clear dose response have been observed, with the highest MS1819-SD dose cohort continuing to show greater than 21% improvement in CFA in evaluable patients. Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA. Favorable trends were also observed on other evaluated endpoints, including Bristol stool scale, number of daily evacuations and weight of stool, and these were consistent with the CFA results.
The Company enrolled 11 of a planned 12 chronic pancreatitis patients over the course of the Phase IIa trial. Due to a sufficient efficacy and safety signal from the enrolled patients, AzurRx will now focus on the treatment of EPI in the cystic fibrosis setting with a planned Phase II trial in patients with cystic fibrosis scheduled to begin in the second half of 2018.
We are very pleased that the MS1819-SD Phase IIa study has been completed and that results to date show that MS1819-SD succeeded in its safety and efficacy objectives, commented Thijs Spoor, CEO of AzurRx. With our recent capital raise and the addition of a clinical trial operations team with extensive experience in late stage cystic fibrosis clinical studies, we are very optimistic about the next phase of MS1819s clinical development as a new therapy for patients suffering from cystic fibrosis.
The results obtained in all dosed patients are very encouraging and confirm the safety and efficacy of MS1819-SD, stated Dr. James Pennington, the Chief Medical Officer of AzurRx. Based on these data, we believe we have the basis for initiating a Phase IIb trial of MS1819 in cystic fibrosis patients in the fall of 2018.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.