Nimbus Therapeutics Announces Expansion of Oral Allosteric TYK2 Inhibitor Program and Provides Additional Business Updates

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through its powerful computational discovery engine, today announced initiation of a Phase 2b study of the company’s investigational oral allosteric TYK2 inhibitor in patients with active psoriatic arthritis. The study represents the second of Nimbus’ planned clinical trials within its TYK2 franchise, alongside a Phase 2b study in moderate-to-severe plaque psoriasis, which initiated dosing in August 2021.

“Nimbus is excited to commence this new TYK2 clinical study as part of our efforts to evaluate patient impact of our oral allosteric TYK2 inhibitor,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “We believe allosteric TYK2 inhibitors offer immense promise as a new class of medicines that are designed to selectively inhibit TYK2 and potentially treat serious autoimmune and inflammatory conditions.”

Nimbus’ allosteric TYK2 inhibitor has demonstrated highly selective inhibition of TYK2 with little evidence of off-target effects in preclinical studies. In Phase 1 studies, Nimbus’ allosteric TYK2 inhibitor has been generally well tolerated and has shown exploratory signals of clinical activity consistent with what is expected of an allosteric TYK2 inhibitor. Nimbus will be presenting data from its Phase 1 studies at the upcoming American Academy of Dermatology annual meeting in March 2022.

“Nimbus is pleased to initiate the second Phase 2b trial with our allosteric TYK2 inhibitor and to further expand our potential impact in addressing serious autoimmune and inflammatory conditions,” said Bhaskar Srivastava, M.D., Ph.D., Vice President of Early Clinical Development at Nimbus. “Many patients with active psoriatic arthritis are not adequately treated, and there is a need for safe and effective oral treatment options.”

Furthermore, Nimbus Therapeutics and Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, reached an agreement resolving all legal claims and business interests between the two companies pertaining to Nimbus’ TYK2 inhibitor. Nimbus retains all rights to its TYK2 inhibitor program and remains solely responsible for continuing progress through clinical development.

Nimbus will present at the virtual 40th Annual J.P. Morgan Healthcare Conference at 9:00 a.m. ET / 6:00 a.m. PT on Monday, January 10, 2022. CEO Jeb Keiper will provide an overview of the company’s progress and anticipated milestones for 2022 and beyond.

About Nimbus Therapeutics
Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple potent and 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 (tyrosine kinase 2) 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 presently has two active clinical trials evaluating its novel allosteric TYK2 inhibitor, an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and the recently initiated active psoriatic arthritis (NCT05153148) study. The psoriatic arthritis Phase 2b trial is a randomized, multicenter, double-blind, placebo-controlled study that will evaluate three dose levels of the investigational therapy taken orally once per day. It is planned to enroll approximately 260 subjects, with a primary endpoint of proportion of subjects achieving at least an American College of Rheumatology (ACR) 20 response at week 12. Additional trial details can be found by visiting ClinicalTrials.gov.

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