Artugen Therapeutics Limited, a Company developing novel live biotherapeutics (LBPs) for patients living with infectious, inflammatory and oncologic diseases announced the first patient dosed with ART24, the Company’s first clinical product candidate for prevention of recurrence of Clostridium difficile infection (CDI).

The advancement of ART24 into the Phase 1 clinical trial was based on its favorable profile exhibited in pre-clinical safety testing, as well as its demonstration of potent and selective in vitro and in vivo activity against C. difficile and associated toxins. The Phase 1 clinical trial is evaluating ART24 for safety, tolerability and pharmacokinetics in a double-blind, placebo-controlled study in patients recently cured of CDI.

ART24 was additionally granted Fast Track by the FDA.

"We are thrilled by the remarkable progress made by the Artugen team and excited about the advancement of the clinical development of ART24," said CEO Ronnie Farquhar. "Thousands of people die each year due to recurrent C. difficile infections and we are pleased that the FDA has granted the ART24 program Fast Track Status."

C. difficile has been categorized as an urgent threat by the Centers for Disease Control and is estimated to cause almost half a million illnesses in the United States each year. Even when successfully treated, CDI recurrence is common and can be as high as 60% in patients who have experienced multiple episodes. Given that an estimated 15,000 deaths are directly attributable to C. difficile infections, preventing CDI recurrence is a critical therapeutic strategy in the management of CDI.

"I am excited about this novel non antibiotic approach that addresses the prevention of CDI recurrence following a primary episode", said Dr. Jessica Allegretti, Principal Investigator in the ongoing Phase 1 clinical trial at the Brigham and Women’s hospital in Boston.

"Preventing CDI remains an unmet medical need as each CDI episode has the potential to cause considerable morbidity and mortality," said Chief Medical Officer, Chris Stevens, MD. "As a first-in-class LBP that acts directly against C. difficile and its toxins, ART24 is a welcome non antibiotic preventative approach to CDI recurrence."

Top-line results from the Phase 1 trial of ART24 are expected by the end of 2020.

ART24 represents a novel class of direct-acting live biotherapeutics (LBPs), which are therapeutic agents with defined clinical benefit claims. As the characterization of the human microbiome and its link to human health has become better understood, the use of LBPs in clinical application represents great opportunity. ART24 is a naturally occurring, pure bacterial strain which was discovered by Artugen Therapeutics in collaboration with APC Microbiome Ireland.

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