- Synthetic Biologics Inc (NYSE: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.
- Price Action: SYN shares are up 0.18% at $0.23 on the last check Tuesday.
