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BioBalance Gets Approval for Pouchitis Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioBalance Corp., a wholly owned subsidiary of New York Health Care, has received approval from the FDA to begin U.S. trials of its proprietary biotherapeutic agent, Probactrix, a prescription drug for pouchitis. Pouchitis is a debilitating complication that can develop following corrective surgical treatment of ulcerative colitis, in which a pouch is constructed to enable normal bowel movements after removal of the diseased colon. This pouch can become inflamed, leading to debilitating gastrointestinal symptoms. Currently, there are no approved treatments for pouchitis. Current management involves short-term and occasionally chronic treatment with antibiotics.

The Phase I/II, randomized, placebo-controlled, multi-center study will be conducted in approximately 63 antibiotic-dependent pouchitis patients to demonstrate the ability of a prescription formulation of Probactrix to maintain symptomatic response of pouchitis symptoms after antibiotic withdrawal.

Probactrix is a single strain of non-pathogenic E.coli M-17 that was originally isolated from the intestinal microflora of a healthy volunteer. One mechanism of action is believed to work by selective displacement of pathogenic bacteria in the digestive tract and preventing their re-colonization, restoring a healthy balance of intestinal flora without the potential negative consequences of antibiotic use.

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