Novel developmental drug shows promise for coeliac disease

TAK-062, a novel endopeptidase under development, is well-tolerated and can rapidly degrade gluten, and may be a potential oral therapeutic for coeliac disease (CeD), a recent study has found.

Researchers performed a phase I dose escalation study conducted in two parts. Part 1 included 24 participants (15 healthy, 9 with CeD) who were given ascending doses of TAK-062 to assess safety. Part 2 included 57 healthy participants in whom gluten clearance was assessed after treatment by aspirating of gastric samples via a nasogastric tube.

In part 1, none of the healthy participants developed treatment-emergent adverse events (TEAEs), which arose in 55.6 percent (n=5) of CeD patients. However, only two CeD patients with TEAEs received the active treatment, both of which were cases of headache. In part 2, TEAEs were documented in six patients, four of whom received various doses of TAK-062; these TEAEs included headache, nausea, vomiting, and epistaxis.

Notably, the highest TAK-062 of 900 mg liquid formulation was well tolerated. There were no TEAEs with severity exceeding grade 1, and none of the side effects in both parts were considered to be related to the study drug. No deaths occurred.

In terms of efficacy, TAK-062 was able to degrade 97 percent to >99 percent of gluten following the consumption of complex meals containing 1–6 g of gluten. Such an effect was observed 20–65 minutes post-dose.

“The ability of TAK-062 to degrade gluten was unaffected by proton pump inhibitor pretreatment and was similar whether administered in liquid or encapsulated spray-dried formulations,” the researchers said. “Further evaluation of TAK-062 as an oral therapeutic for patients with CeD is supported by these findings, and phase II efficacy studies are planned.”