Thursday, January 28, 2021 7:20:45 AM
BY GlobeNewswire
— 7:00 AM ET 01/28/2021
DELRAY BEACH, Fla., Jan. 28, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ( AZRX) (“AzurRx” or the “Company”) , a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of patient enrollment in the first cohort of the Phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
The Phase 2b OPTION 2 trial extension arm is currently dosing patients at clinical trial sites in the U.S. and Europe who have participated in the previous arms of the OPTION 2 trial. The goal of the MS1819 clinical program is to provide cystic fibrosis patients with a safe and effective therapy to control EPI, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can lead to a chronic nutritional deficiency. For cystic fibrosis patients, maintaining proper nutritional levels is essential to ensure healthy growth, weight management and good lung function.
James Sapirstein, President and Chief Executive Officer of AzurRx BioPharma ( AZRX), stated, “The extension arm of the Phase 2b OPTION 2 trial is providing us with an opportunity to determine both the optimized dosage and delivery mechanism of MS1819. We have fully enrolled the most important cohort of the extension study and would like to thank both our clinical collaborators and patients for their continued participation in the study. We continue to be encouraged by the absence of any reports of serious adverse events to date, and eagerly look forward to reporting topline results from this trial in Q1 2021.”
OPTION 2 Extension Study
The Phase 2b OPTION 2 study is an open-label, multi-center, crossover clinical trial designed to investigate the safety, tolerability, and efficacy of MS1819 in a head-to-head comparison against the current standard of care for EPI, porcine pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint is the coefficient of fat absorption (CFA). AzurRx BioPharma ( AZRX) initiated the additional study arm, the Phase 2b OPTION 2 extension trial, to identify both the optimal dose and the optimal delivery method for MS1819 using immediate-release capsules at higher dose levels than previous early-stage clinical trials.
To date, there have been no serious adverse events reported during either the Phase 2b OPTION 2 trial or its extension arm. The Phase 2b OPTION 2 extension trial is enrolling volunteers 18 years or older at trial sites in the U.S. and Poland who have completed the OPTION 2 crossover trial at higher dose levels relative to the previous OPTION 1 trial. Trial participants will be treated with MS1819 over a two-week-period. AzurRx BioPharma ( AZRX) expects to report topline data by the end of first quarter 2021.
Recent FWBI News
- First Wave BioPharma and Celiac Journey to Host Nasdaq Event in Support of Celiac Disease Awareness Month • GlobeNewswire Inc. • 05/09/2024 11:00:00 AM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/08/2024 09:16:31 PM
- First Wave BioPharma Announces Invited Paper for Special Edition on Celiac Disease in Peer-Reviewed Scientific Journal, Nutrients • GlobeNewswire Inc. • 04/24/2024 11:00:00 AM
- First Wave BioPharma CEO James Sapirstein to Present at the Planet MicroCap Showcase • GlobeNewswire Inc. • 04/17/2024 11:00:00 AM
- First Wave BioPharma CEO James Sapirstein to Participate in 2024 Longwood Healthcare Leaders Conference • GlobeNewswire Inc. • 04/15/2024 11:00:00 AM
- First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference • GlobeNewswire Inc. • 03/18/2024 11:00:00 AM
- First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline • GlobeNewswire Inc. • 03/14/2024 10:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2024 10:26:27 PM
- First Wave BioPharma to Participate In ‘Fireside Chat’ at the 36th Annual Roth Conference • GlobeNewswire Inc. • 03/05/2024 12:00:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 03/04/2024 10:29:57 PM
- First Wave BioPharma, Inc. to Raise Approximately $4.0 Million of Gross Proceeds in Registered Direct Offering • GlobeNewswire Inc. • 03/04/2024 01:00:00 PM
- First Wave BioPharma CEO to Present at the BIO CEO & Investor Conference 2024 • GlobeNewswire Inc. • 02/13/2024 12:00:00 PM
- First Wave BioPharma to Present at the DealFlow MicroCap Conference • GlobeNewswire Inc. • 01/23/2024 12:00:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/18/2024 09:01:56 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/18/2024 05:15:15 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/17/2024 09:02:51 PM
- First Wave BioPharma CEO to Present at the Sequire Investor Summit 2024 in Puerto Rico • GlobeNewswire Inc. • 01/17/2024 12:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 01/08/2024 10:14:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:13:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:13:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/04/2024 01:22:04 PM
- First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024 • GlobeNewswire Inc. • 01/04/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:54:55 AM
- Form RW - Registration Withdrawal Request • Edgar (US Regulatory) • 12/28/2023 05:21:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 10:23:52 PM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM