Microcyn demonstrated a positive clinical response, defined as the clinical cure or improvement of infection, as a monotherapy and in combination with levofloxacin, a systemic antibiotic. No serious drug-related adverse events were reported in any of the three treatment arms. The company plans to request an end-of-Phase II meeting with the FDA to discuss Phase II results and define the scope and parameters for advancing the clinical program.
The primary Phase II endpoint was clinical cure or improvement of infection at the end of therapy (day 10). Clinical cure of infection is defined as the elimination of all five of the Infectious Diseases Society of America (IDSA) visual symptoms that characterize mildly infected diabetic foot ulcers, including: presence of erythema less than two centimeters around the ulcer, detectable increase in temperature of the wound or periwound area, culturable exudate or extension of redness is present, localized swelling or induration and localized tenderness or pain. Clinical improvement of infection is defined as the elimination of at least two of the five ISDA symptomatic visual indications.
Hoji Alimi, CEO and founder of Oculus said: “We believe that Microcyn has the potential to be the first topical drug to provide patients with a favorable safety profile and effective antimicrobial properties. We are now focusing on further analysis of the complete trial data to prepare for our end-of-Phase II meeting with the FDA.”