Pharmacokinetic profile supports potential for once-daily dosing in moderate-to-severe psoriasis 

Wide range of doses explore higher ranges of TYK2 inhibition in the clinic than reported by other agents 

CAMBRIDGE, Mass. – May 19, 2022 – Nimbus Therapeutics, a clinical-stage company that is working to design and develop breakthrough medicines through its powerful computational drug discovery engine, today announced the presentation of new data from multiple Phase 1 clinical studies of its investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor, NDI-034858, in both healthy volunteers and patients with moderate-to-severe psoriasis. The data will be presented in a poster session at the 2022 Society for Investigative Dermatology (SID) Annual Meeting, being held May 18-21, 2022, in Portland, OR.

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.

“Nimbus’ oral allosteric TYK2 inhibitor has demonstrated exceptional functional selectivity, and has an encouraging clinical activity profile and a favorable tolerability profile. Notably, there is evidence that a single amino acid difference at the allosteric binding pocket may enable greater TYK2 selectivity of NDI-034858 over deucravacitinib,” said Bhaskar Srivastava, M.D., Ph.D., Senior Vice President, Clinical Development at Nimbus. “These results support continued development of this investigational drug candidate as a potential oral treatment option for patients with autoimmune diseases.”

The poster, titled “Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in Phase 1 studies of the novel allosteric tyrosine kinase 2 (TYK2) 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.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company working to design and develop breakthrough medicines through its powerful and comprehensive 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, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About the Nimbus TYK2 Program

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. Additional trial details can be found by visiting ClinicalTrials.gov.

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

Download PDF

View Poster