Cellceutix Initiates Dose Escalation in Phase 2 Trial of Brilacidin for Ulcerative Proctitis

Cellceutix Initiates Dose Escalation in Phase 2 Trial of Brilacidin for Ulcerative Proctitis
Cellceutix has initiated the dose escalation of brilacidin (PMX-30063) in the second cohort of patients enrolled in a Phase 2 clinical trial evaluating the drug candidate for the treatment of ulcerative proctitis and ulcerative proctosigmoiditis (UP/UPS), two types of ulcerative colitis (UC). UP is a mucosal inflammatory bowel disease of unknown cause involving only the rectum. UP evolves to UPS when both the rectum and the distal colon are involved. Brilacidin is the company’s lead drug candidate modeled after host defense proteins (HDPs), the front-line of defense in the immune system. It's a small synthetic molecule that kills pathogens and functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. After reviewing safety data from the first cohort (on 50 mg), researchers concluded that brilacidin administered for six weeks (42 consecutive days) as a retention enema appeared to be well-tolerated by patients with no measurable systemic absorption reported. This provided the green light researchers needed to initiate a dose escalation to 100 mg once daily. The ongoing Phase 2 open-label, proof-of-concept clinical trial began enrolling its first patients in June. The trial is evaluating brilacidin for induction of remission, not merely maintenance, in patients suffering from mild to moderate UP/UPS. The trial includes three sequential, progressively escalating cohorts with six patients enrolled in each. The cohorts started at 50 mg, then 100 mg, and if
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