Nimbus Therapeutics has reported positive data from a Phase IIb clinical trial of NDI-034858, an allosteric TYK2 inhibitor, in moderate-to-severe plaque psoriasis patients.
The double-blind, multicentre, placebo-controlled, randomised study was designed for evaluating the tolerability, safety, and efficacy of four doses of NDI-034858 given orally once a day to psoriasis patients.
Findings from 259 trial participants showed that the allosteric TYK2 inhibitor achieved statistical significance, with a greater number of patients reaching PASI-75, compared to a placebo at 12 weeks.
The company stated that NDI-034858 has also achieved additional endpoints in the study, and its safety was consistent with other allosteric TYK2 inhibitors.
It intends to present this trial data at an upcoming medical conference.
Nimbus Clinical Development senior vice-president Bhaskar Srivastava said: “We are pleased to report success from our Phase 2b psoriasis patient trial that supports NDI-034858’s best-in-class potential among the new class of allosteric TYK2 inhibitors.
“Additionally, the consistent safety profile seen in this study reinforces TYK2 inhibitors as a differentiated non-JAK therapeutic class.”
The company stated that NDI-034858 is being assessed to treat several autoimmune diseases.
It showed wide therapeutic margins and exceptional functional selectivity in preclinical studies.
The therapy is currently being evaluated in an ongoing Phase IIb trial in active psoriatic arthritis patients, in addition to psoriasis.
Nimbus plans to launch the Phase III studies in psoriasis, as well as the future trials in other autoimmune indications such as inflammatory bowel disease (IBD) and lupus.
Last November, the company dosed the first participant in its Phase I/II trial of NDI-101150 in solid tumour patients.