AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, this morning issued a clinical development and strategic corporate update. In the update, the company reports that the first patients have been dosed in its phase II OPTION study to investigate MS1819-SD in cystic fibrosis (“CF”) patients with exocrine pancreatic insufficiency (“EPI”). Planned enrollment of the study is anticipated to include approximately 30 CF patients, with initial top line data results expected in mid-2019. The OPTION study is presently enrolling patients at five sites in the U.S. and anticipates up to six additional U.S. sites initiating soon. Furthermore, AzurRx has received approval from the Polish Ministry of Health to expand enrollment to include European patients, with the first European clinical trial sites being permitted to enroll soon. In addition, the company also announced that it has raised $2 million from the sale of a convertible note to its largest shareholder, convertible at $2.50 per share. “Having the first patients dosed in our OPTION study of MS1819-SD in patients with CF represents a significant milestone for AzurRx and demonstrates that we are on track to complete our Phase 2 study by mid-2019 as previously announced,” AzurRx BioPharma CEO Thijs Spoor stated in the news release.
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About AzurRx BioPharma, Inc.
AzurRx BioPharma is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819-SD recombinant lipase for EPI is the company’s lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the company can be found at www.AzurRx.com.
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