15 September 2021 - - US-based biotechnology company Nimbus Therapeutics has started dosing patients in the Phase 2b study of the company's oral allosteric TYK2 inhibitor, the company said.

The study will assess the efficacy, safety, and tolerability of the investigational therapy in patients with moderate to severe plaque psoriasis.

TYK2 inhibition is a promising treatment approach for a wide range of autoimmune and inflammatory diseases thanks to the protein's central role in both the innate and adaptive immune responses.

Nimbus' allosteric TYK2 inhibitor has demonstrated highly selective inhibition of TYK2 with little evidence of off-target effects, and in Phase 1 studies, demonstrated safety and tolerability with efficacy signals consistent with what is expected of an allosteric TYK2 inhibitor.

The Phase 2b trial (NCT# 04999839) is a randomized, multicenter, double-blind, placebo-controlled study that will evaluate four dosages of the investigational therapy taken orally once per day. It is planned to enroll approximately 250 subjects.

Its primary endpoint will be the proportion of patients achieving PASI-75, meaning a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index, at 12 weeks. Additional trial details can be found by visiting ClinicalTrials.gov.

Nimbus said it plans to initiate multiple other Phase 2 studies in various autoimmune and inflammatory diseases in 2021 and 2022 to elucidate the full range of potential patient benefit from its oral allosteric TYK2 inhibitor.

Nimbus Therapeutics designs breakthrough medicines.

Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle.

Nimbus is headquartered in Cambridge, Mass.