AzurRx BioPharma (NASDAQ: AZRX), a clinical stage biopharmaceutical company specializing in the development of targeted, nonsystemic therapies for gastrointestinal (“GI”) diseases, has entered into an agreement with PPD Inc. (NASDAQ: PPD) for its upcoming phase 1b/2a clinical trial. PPD, a leading global contract research organization will manage the clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, or FW-420 (“CRO”). The trial is designed to evaluate proprietary formulations of micronized niclosamide for grade 1 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (“ICIs”). This is the second clinical trial involving niclosamide that the CRO will manage for AzurRx. As previously announced, PPD is also managing AzurRx’s phase 2 clinical trial to investigate niclosamide as a treatment for COVID-19-related gastrointestinal infections; that trial is planned for Q2 2021. “The goal of our FW-420 clinical program is to develop a safe, effective, and non-systemic treatment for immune checkpoint inhibitor-associated colitis, and we are excited to once again partner with PPD to begin the preparations for our Phase 1b/2a clinical trial,” said AzurRx BioPharma president and CEO James Sapirstein in the press release. “The development of immune checkpoint inhibitors has marked a major advance in cancer therapeutics, but the drugs can induce a serious inflammation of the bowels, which if left unchecked, can prove life-threatening and force patients to halt treatment. There are currently no treatments available for grade 1 colitis resulting from the use of ICIs. We believe an oral, non-absorbed treatment, such as FW-420, could prevent the condition from progressing and enable patients to continue their treatment regimen uninterrupted. We hope to rapidly advance the FW-420 program with the support of PPD.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, nonsystemic therapies for gastrointestinal (“GI”) diseases. The company has a pipeline of three gut-restricted GI assets. The first is MS1819, a recombinant lipase biologic for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis and chronic pancreatitis, with two ongoing phase 2 clinical trials. The other two are clinical-stage therapies using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-420, for the treatment of grade 1 immune checkpoint inhibitor associated colitis (“ICI-AC”) and diarrhea in oncology patients, and FW-1022, for the treatment of COVID-19 gastrointestinal infections. The company is headquartered in Delray Beach, Florida, with clinical operations in Hayward, California. For more information, visit the company’s website at www.AzurRx.com.
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