Policy & Regulation
Nimbus Therapeutics Presents Additional Clinical Data from Phase 1 Studies of Oral Allosteric TYK2 Inhibitor at SID Annual Meeting
20 May 2022 - - US-based clinical-stage company Nimbus Therapeutics has presented new data from multiple Phase 1 clinical studies of its investigational oral allosteric tyrosine kinase 2 inhibitor, NDI-034858, in both healthy volunteers and patients with moderate-to-severe psoriasis, the company said.

The data are being presented in a poster session at the 2022 Society for Investigative Dermatology annual meeting, being held May 18-21, 2022, in Portland, Oregon.

Data presented at SID reflect analyses of pharmacokinetics, pharmacodynamics, tolerability and clinical activity of NDI-034858.

As previously reported, NDI-034858 was observed to be generally well tolerated, and it showed a dose-dependent trend in exploratory clinical activity.

The pharmacokinetic profile of NDI-034858 observed in healthy volunteers supports the potential for once-daily dosing, with 50 mg expected to cover IC90 for 24 hours.

Additionally, an analysis of the biochemical selectivity of NDI-034858 using proprietary structure-based computational modeling found that Nimbus' TYK2 inhibitor was highly selective, with approximately 13,000 times more selectivity than deucravacitinib.

The poster, titled "Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in Phase 1 studies of the novel allosteric tyrosine kinase 2 inhibitor NDI-034858," will be presented on Thursday, May 19, from 4:30-6:30 p.m. PT.

Phase 2b clinical studies to evaluate NDI-034858 in moderate-to-severe plaque psoriasis (NCT04999839) and active psoriatic arthritis (NCT05153148) are ongoing.

Nimbus Therapeutics is a clinical-stage company working to design and develop medicines through its computational drug discovery engine.

Nimbus' pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, Massachusetts.

TYK2 is an important signal-transducing kinase that mediates immune signaling and is important in both adaptive and innate immune cells.

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

Nimbus is conducting a number of Phase 2 clinical studies to evaluate its novel allosteric TYK2 inhibitor, including an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and an ongoing psoriatic arthritis (NCT05153148) study.
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