Synthetic Biologics Posts Encouraging Safety Data on SYN-020 In Healthy Volunteers

Synthetic Biologics Inc SYN has announced safety data from its Phase 1 multiple ascending dose (MAD) trial of SYN-020 intestinal alkaline phosphatase (IAP).
The Phase 1 MAD study enrolled 32 healthy adult volunteers into four cohorts with SYN-020 administered orally in doses ranging from 5 mg to 75 mg twice daily for 14 days, with a follow-up evaluation at day 35.
SYN-020 is a recombinant bovine IAP formulated for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation.
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile and was well-tolerated across all dose levels.
There were a few treatment-related adverse events, and all were mild and resolved without medical intervention.
The most common adverse event, constipation, occurred in three out of 24 subjects in the treatment arm and one out of eight subjects in the placebo arm.
Additional analyses, including fecal levels of SYN-020 and anti-drug antibody levels, are ongoing.
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