2020 – Exegi Pharma

FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic standard

November 12, 2020 (Rockville, Maryland): ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. This designation grants certain benefits to drugs and biological products intended to treat diseases which affect less than 200,000 patients in the U.S. EXE-346 is an LBP which contains a fixed-proportion of 8 strains of live probiotic bacteria which are intended for oral administration. Pouchitis is a condition which impacts patients who have had a surgical procedure to remove their colon. The surgery, called a pouch anastomosis, creates an intestinal “J-Pouch” ...

First Published Clinical Trial Using Live Biotherapeutic Candidate in COVID-19 Patients Suggests Role In Improving Outcome standard

ROCKVILLE, Md., July 13, 2020 ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy. COVID-19 crisis exploded in Italy and clinicians struggled to navigate patient care. Investigators at Policlinico Umberto I, “Sapienza” University of Rome hypothesis that a bacterial formulation, with a specific biochemical and immunological profile, could trigger the production of ...

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