Synthetic Biologics has initiated enrolment and dosed eight subjects in a Phase I clinical trial of SYN-020 intestinal alkaline phosphatase (IAP) to potentially prevent and treat gastrointestinal (GI) diseases.
Formulated for oral delivery to the small intestine, SYN-020 is a recombinant bovine IAP.
The ongoing, placebo-controlled, multiple-ascending dose (MAD) Phase I trial will assess the safety, tolerability and biodistribution of repeated doses of SYN-020 in up to 32 healthy adult subjects.
They will be categorised into four sequential arms of eight each to receive either oral twice-daily 5mg, 15mg, 45mg or 75mg doses of SYN-020 for 14 days.
Synthetic will conduct a safety analysis, on concluding each arm, to assess if advancing to higher doses is feasible.
Topline results from the trial are expected in the second quarter of next year.
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A Phase I single-ascending dose (SAD) clinical trial of SYN-020 that enrolled 24 healthy adult subjects concluded recently.
These participants were categorised into four arms to receive single oral doses of SYN-020 ranging from 5mg to 150mg.
Initial data analyses showed that SYN-020 had a favourable safety profile and was well-tolerated at all tested doses in the trial.
Furthermore, no adverse events and serious adverse events linked to the treatment were reported.
Synthetic Biologics CEO and chief financial officer Steven Shallcross said: “We are excited to announce the initiation of the Phase I multiple-ascending dose clinical study, which is an important milestone in furthering the clinical development of SYN-020 for multiple potential indications.
“SYN-020 is a promising, versatile programme that we believe has enormous potential to help address a considerable need for innovative new therapies targeting disorders that stem from immune and inflammatory damage to the intestine, including celiac disease, non-alcoholic fatty liver disease (NAFLD), age-related metabolic and inflammatory diseases, and radiation enteropathy.”