AzurRx BioPharma (NASDAQ: AZRX), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (“GI”) diseases, today announced its entry into an agreement with PPD Inc. (NASDAQ: PPD ), a leading global contract research organization (“CRO”), for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated GI infections. Under the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022. Licensed in January from FirstWave Bio Inc., the goal of AzurRx’s FW-1022 clinical program is to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19. “We are moving rapidly to initiate the planned Phase 2 trial of FW-1022 and are pleased to have PPD as our CRO partner given the company’s proven expertise and track record of clinical excellence,” said James Sapirstein, president and CEO of AzurRx BioPharma. “Even as the vaccine rollout continues, millions of people will become infected with the SARS-CoV-2 virus, and recent study data suggest approximately one in five of those stricken will suffer COVID-related GI infections with symptoms that include loss of appetite, nausea, vomiting and diarrhea. There is no therapeutic available to treat this condition, and we believe FW-1022 offers the potential to address this serious and possibly long-lasting after-effect of COVID-19.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (“GI”) diseases. The company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 immune checkpoint inhibitor colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.AzurRx.com.
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