Atterx Biotherapeutics Receives FDA Fast Track Designation forC-1205 for the Prevention of Catheter Associated Urinary Tract Infections (CAUTI)

"We are very pleased to receive Fast Track Designation (FTD) from the FDA for C-1205 and believe this classification underscores the urgent need for improved options for patients dealing with Catheter Associated Urinary Tract Infections (CAUTIs), said James Millar, Chief Executive Officer at Atterx Biotherapeutics. "It's very encouraging that the FDA confirms that the presented C-1205 data meet expectations to address this important unmet medical need".

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The company firmly believes that C-1205 will prevent CAUTI in most patients and will therefore greatly reduce the use of traditional antibiotics in the clinic (a major goal of hospitals, and the CDC). Urinary tract infections are the most common type of healthcare associated infection, responsible for more than 40% of all reported infections. UTIs lead to longer hospital stays, greater healthcare costs, increased antibiotic use and most importantly an estimated 45,000 to 50,000 deaths each year in the U.S. alone.

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The FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address important unmet medical needs. The aim is to accelerate the development of urgently needed new drugs for patients. Drugs granted FTD are eligible for more frequent meetings with the FDA to discuss the drug development plan and ensure the collection of appropriate data needed to support approval, as well as eligibility for Accelerated Approval, Priority Review and Rolling Review if relevant criteria are met.

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