- First three sufferers enrolled in dose escalation trial utilizing delayed-release enteric capsules
- Topline information anticipated in 1H 2021
NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), an organization specializing in the event of non-systemic, recombinant therapies for gastrointestinal illnesses, at present introduced that’s has enrolled the primary three sufferers in its Phase 2b OPTION 2 medical trial to analyze MS1819 in cystic fibrosis (CF) sufferers with exocrine pancreatic insufficiency (EPI). The trial will enroll roughly 30 CF sufferers with high line information from the examine anticipated in 1H 2021.
The Phase 2b multi-center examine is designed to analyze the protection, tolerability, and efficacy of MS1819 (2.2 gram and four.four gram doses in enteric capsules) in a head-to-head comparability in opposition to the present porcine enzyme substitute remedy (PERT) normal of care. The major efficacy endpoint is the coefficient of fats absorption (CFA), with secondary endpoints of stool weight, indicators and signs of malabsorption and coefficient of nitrogen absorption (CNA).
“Enrolling the first patient in our Phase 2b OPTION 2 trial is an important milestone and we appreciate the support from our clinical trial specialists and centers. We are optimistic that our delayed-release delivery of MS1819 will achieve our primary and secondary efficacy endpoints in this study,” stated Dr. James Pennington, Chief Medical Officer of AzurRx. “We anticipate data from this trial will inform the optimal dose for our pivotal Phase 3 study, and look forward to top line results in the first quarter of next year.”
James Sapirstein, Chief Executive Officer of AzurRx, added, “We are very pleased to announce that patient dosing in the OPTION 2 trial has begun in the U.S. This represents an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis. Despite the challenges posed by the COVID-19 pandemic, the AzurRx team has been able to successfully activate new clinical trial sites and work with investigators to safely admit patients into the trial.”
Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial is designed to analyze the protection, tolerability and efficacy of MS1819 (2.2 and four.four gram doses in enteric capsules) in a head-to-head comparability versus the present normal of care, porcine pancreatic enzyme substitute remedy tablets. The OPTION 2 trial might be an open-label, crossover examine, carried out in 15 websites in the U.S. and Europe. A complete of 30 CF sufferers 18 years or older might be enrolled. MS1819 might be administered in enteric capsules to offer gastric safety and permit optimum supply of enzyme to the duodenum. Patients will first be randomized into two cohorts: to both the MS1819 arm, the place they obtain a 2.2 gram day by day oral dose of MS1819 for 3 weeks; or to the PERT arm, the place they obtain their pre-study dose of PERT tablets for 3 weeks. After three weeks, stools might be collected for evaluation of coefficient of fats absorption. Patients will then be crossed over for an additional three weeks of the choice remedy. After three weeks of cross-over remedy, stools will once more be collected for evaluation of CFA. A parallel group of sufferers might be randomized and studied in the identical trend, utilizing a four.four gram day by day dose of MS1819. All sufferers might be adopted for an extra two weeks after finishing each crossover remedies for publish examine security remark. Patients might be assessed utilizing descriptive strategies for efficacy, evaluating CFA between MS1819 and PERT arms, and for security.
MS1819 is a recombinant lipase enzyme for the remedy of exocrine pancreatic insufficiency related to cystic fibrosis and power pancreatitis. MS1819, provided as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fats molecules in the digestive tract of EPI sufferers in order that they are often absorbed as vitamins. Unlike the usual of care, the MS1819 artificial lipase doesn’t comprise any animal merchandise.
About Exocrine Pancreatic Insufficiency
EPI is a situation characterised by deficiency of the exocrine pancreatic enzymes, ensuing in a affected person’s incapability to digest meals correctly, or maldigestion. The deficiency in this enzyme may be liable for greasy diarrhea, fecal urge and weight reduction.
There are greater than 30,000 sufferers in the U.S. with EPI attributable to cystic fibrosis in accordance with the Cystic Fibrosis Foundation and roughly 90,000 sufferers in the united stateswith EPI attributable to power pancreatitis in accordance with the National Pancreas Foundation. Patients are at present handled with porcine pancreatic enzyme substitute tablets.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical firm specialised in the analysis and improvement of non-systemic biologics for gastrointestinal problems. The Company is concentrated on the event of its lead drug candidate, MS1819. AzurRx is at present conducting two Phase 2 medical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination remedy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme substitute remedy, the present normal of care. The Company is headquartered in New York, NY, with scientific operations primarily based in Langlade, France and medical operations in Hayward, California. Additional data on the Company may be discovered at www.azurrx.com.
This press launch might comprise sure statements regarding future outcomes that are forward-looking statements. These statements usually are not historic info, however as an alternative signify solely the Company’s perception relating to future occasions, many of which, by their nature, are inherently unsure and outdoors of the Company’s management. It is feasible that the Company’s precise outcomes and monetary situation might differ, presumably materially, from the anticipated outcomes and monetary situation indicated in these forward-looking statements, together with whether or not outcomes obtained in preclinical and nonclinical research and medical trials might be indicative of outcomes obtained in future medical trials; whether or not preliminary or interim outcomes from a medical trial such because the interim outcomes introduced might be indicative of the ultimate outcomes of the trial. Additional data regarding the Company and its enterprise, together with a dialogue of components that would materially have an effect on the Company’s monetary outcomes, together with these associated to the medical improvement of MS1819, the outcomes of its medical trials, and the influence of the coronavirus (COVID-19) pandemic on the Company’s operations and present and deliberate medical trials, together with, however not restricted to delays in medical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-Okay for the 12 months ended December 31, 2019 underneath the heading “Risk Factors,” in addition to the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press launch are made solely as of the date of this press launch, and we don’t undertake any obligation to publicly replace or right any forward-looking statements to mirror occasions or circumstances that subsequently happen or of which we hereafter grow to be conscious.
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