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AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced that its French subsidiary, AzurRx SAS, received approximately 459,000 Euros ($550,000) in non-dilutive funding from the French government as part of the 2020 CIR (French Research Tax Credit). This funding will support ongoing clinical trials for MS1819, aimed at treating exocrine pancreatic insufficiency in cystic fibrosis patients. CEO James Sapirstein expressed gratitude for the support, highlighting that the funding will bolster their European clinical efforts during the COVID-19 pandemic.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) will participate in the Emerging Growth Conference on May 12, 2021, at 10:30 a.m. EDT. The management team will present an overview of the company's business and clinical development, highlighting milestones for 2021 and early 2022. Interested attendees can register for the event here. If unable to attend, an archived webcast will be available post-event. AzurRx focuses on non-systemic therapies for gastrointestinal diseases, with key candidates targeting exocrine pancreatic insufficiency and COVID-19 gastrointestinal infections.
AzurRx BioPharma (NASDAQ: AZRX) announced that President and CEO James Sapirstein will present at the Investor Summit Group’s Q2 Virtual Summit on May 17, 2021, at 9:30 a.m. EDT. The presentation will cover the company’s business overview and clinical development programs, highlighting 2021 and early 2022 milestones. Additionally, the management team will engage in virtual one-on-one meetings with registered investors. AzurRx specializes in non-systemic therapies for gastrointestinal diseases and has several assets in clinical trials.
AzurRx BioPharma (NASDAQ: AZRX) announced significant clinical and corporate developments in a letter to shareholders dated April 15, 2021. The company outlined its progress on two major drug candidates: FW-1022, for COVID-19 gastrointestinal infections, which recently entered Phase 2 trials, and FW-420 for immune checkpoint inhibitor-associated colitis. The company also reported mixed results from its Phase 2b trial of MS1819 for pancreatic insufficiency, prompting a new formulation strategy. Additionally, AzurRx raised approximately $18 million in Q1 2021 through public offerings and private placements.
AzurRx BioPharma (NASDAQ: AZRX) announced an agreement with PPD to manage its upcoming Phase 1b/2a clinical trial for micronized niclosamide, aimed at treating grade 1 colitis and diarrhea in oncology patients on immune checkpoint inhibitors. The trial is expected to begin in the second quarter of 2021 and will utilize both oral and topical formulations of niclosamide. This follows the ongoing Phase 2 trial targeting COVID-19-related gastrointestinal infections. The company aims to provide a non-systemic treatment to help patients continue their cancer therapies without interruption.
AzurRx BioPharma has initiated its Phase 2 RESERVOIR clinical trial of FW-1022, a micronized oral formulation of niclosamide, targeting COVID-19 related gastrointestinal infections. Patient enrollment is set for April 2021, with topline data expected in Q1 2022. The trial aims to confirm safety and efficacy in clearing the SARS-CoV-2 virus from the GI tract, using fecal virus clearance as the primary efficacy measure. This study may provide insights into addressing 'long haul' COVID-19 symptoms, particularly in patients experiencing severe GI complications.
AzurRx BioPharma (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 clinical trial evaluating MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency. The trial showed MS1819 was safe and well-tolerated, and demonstrated drug activity. However, it did not consistently meet its primary efficacy endpoint of coefficient of fat absorption (CFA). The variability in efficacy was attributed to the enteric capsule formulation. The company plans to develop a new optimized formulation and has raised approximately $22.5 million in Q1 2021 to fund further development.
AzurRx BioPharma is set to host a conference call and audio webcast on March 31, 2021, at 4:30 p.m. ET, to discuss topline results from its Phase 2b OPTION 2 clinical trial involving MS1819 for treating cystic fibrosis patients with exocrine pancreatic insufficiency.
The trial compared MS1819 against current enzyme replacement therapy, focusing on fat absorption metrics. The study involved 30 patients across 15 sites. Results will indicate the efficacy and safety of the new therapy in improving patient outcomes.
AzurRx BioPharma announced the completion of enrollment in its Phase 2 trial for MS1819 combined with porcine-derived pancreatic enzyme replacement therapy (PERT) to treat severe exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. The trial aims to enhance fat absorption and alleviate symptoms in patients who do not respond adequately to PERT alone. Previous results showed promising improvements in key efficacy endpoints. Top-line results from this combination trial are expected in Q2 2021, following the recent completion of a related monotherapy trial.
AzurRx BioPharma (NASDAQ: AZRX) announced the completion of patient enrollment in its Phase 2b OPTION 2 trial for MS1819, targeting cystic fibrosis patients with exocrine pancreatic insufficiency. A total of 30 patients were enrolled, and top-line data is expected by the end of Q1 2021. The trial aims to compare the safety and efficacy of MS1819, a synthetic lipase, against the current porcine enzyme replacement therapy. This milestone is crucial as it will inform dosing for a potential Phase 3 study and aims to reduce the pill burden for patients.
