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AzurRx BioPharma (NASDAQ:AZRX) announced a binding agreement with Asymchem for the development and production of MS1819, aimed at treating exocrine pancreatic insufficiency. Asymchem will handle fermentation and production under cGMP conditions. James Sapirstein, AzurRx's COO, emphasized the importance of this partnership in reducing manufacturing costs for its Phase 3 clinical trial. Asymchem's expertise is expected to optimize MS1819's development and enhance its market potential, supporting AzurRx's ongoing Phase 2 trials for the drug.
AzurRx BioPharma (NASDAQ: AZRX) is advancing efforts to develop synthetic alternatives to porcine-derived pharmaceuticals, specifically targeting exocrine pancreatic insufficiency (EPI) linked to cystic fibrosis. The company's lead candidate, MS1819, is undergoing two Phase 2 clinical trials, showing promising results in enhancing fat absorption without adverse effects. Notably, supply chain issues from pork ingredient variability and disease risks highlight the need for such alternatives. The firm has activated two trial sites in Turkey, with a full data readout expected in Q2 2021.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) has established a Scientific Advisory Board (SAB) featuring renowned experts in cystic fibrosis and chronic pancreatitis. The board aims to enhance the clinical development of MS1819, targeting exocrine pancreatic insufficiency in patients suffering from these conditions. CEO James Sapirstein expressed enthusiasm for the expertise brought by the SAB members, which include Dr. Michael Konstan, Dr. Darwin L. Conwell, and Dr. Michael Wilschanski. Their involvement signals a strategic advancement as the company prepares to transition MS1819 from Phase 2 to a pivotal Phase 3 clinical trial.
AzurRx BioPharma has initiated two clinical trial sites in Turkey for its Phase 2 Combination Therapy trial of MS1819, targeting cystic fibrosis patients with severe exocrine pancreatic insufficiency. This follows the activation of six sites in Hungary, with eight of the planned twelve sites now active. The trial aims to enroll approximately 24 patients, and topline data is expected in Q2 2021. MS1819 is designed to enhance nutrient absorption in patients unable to achieve normal fat digestion, providing a promising alternative to traditional enzyme therapies.
AzurRx BioPharma (NASDAQ: AZRX) celebrates the one-year anniversary of CEO James Sapirstein's leadership, highlighting significant achievements in developing MS1819, a potential replacement for porcine-derived pancreatic enzyme therapy. The company raised $22.1 million in capital, ensuring adequate funds for two ongoing Phase 2 clinical trials. Despite challenges from COVID-19, patient enrollment continues, with positive interim data reported. AzurRx has exited preclinical programs to streamline operations and aims for top line data releases in early 2021.
AzurRx BioPharma (NASDAQ: AZRX) announced two accepted abstracts for the North American Cystic Fibrosis Conference (NACFC) from October 7 to 23, 2020. These include results from the Phase 2 OPTION clinical trial of non-porcine MS1819 lipase, which showed good tolerance at a daily dose of 2g. Additionally, the company identified an effective enteric capsule for MS1819, enhancing its delivery into the duodenum. The findings aim to position MS1819 as a safer alternative to traditional porcine enzyme therapies for cystic fibrosis patients.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) will present at two investor conferences: the 2020 H.C. Wainwright 22nd Annual Global Investment Conference on September 14 at 4:30 p.m. ET and the 2020 LD 500 Virtual Conference on September 4 at 11:40 a.m. ET. CEO James Sapirstein will present virtually and participate in one-on-one investor meetings. The company is focused on developing non-systemic therapies for gastrointestinal diseases, particularly its lead drug candidate, MS1819, currently undergoing Phase 2 clinical trials.
AzurRx BioPharma has enrolled its first three patients in the Phase 2b OPTION 2 clinical trial for MS1819, targeting cystic fibrosis patients with exocrine pancreatic insufficiency. This trial aims to compare MS1819 with standard porcine enzyme replacement therapy, focusing on safety and efficacy metrics, including the coefficient of fat absorption. Topline data is expected in the first half of 2021. The study involves approximately 30 patients across 15 sites in the U.S. and Europe, marking a significant milestone despite challenges from the COVID-19 pandemic.
AzurRx BioPharma (NASDAQ: AZRX) provided an update on its clinical trials and financing in a letter from CEO James Sapirstein. The interim data from the combination therapy trial showed positive results, with the primary efficacy endpoint met and no serious adverse events reported. The company announced a secure financial position after raising approximately $15.2 million from the Series B Private Placement, funding operations through Q3 2021. Clinical trial timelines have been adjusted, with topline data expected for Option 2 in Q1 2021 and the combination therapy trial in Q2 2021.
AzurRx BioPharma reported positive results from its Phase 2 trial of MS1819 for treating severe exocrine pancreatic insufficiency in cystic fibrosis patients. The first five patients showed a clinically significant improvement of over 80% in the coefficient of fat absorption across all doses. No adverse safety events were reported, strengthening the profile of MS1819. Topline data is expected in 1Q 2021. The trial aims to enroll 24 patients, with enhanced nutrient absorption and quality of life as key outcomes.
