No box warning set to leave Bristol’s Sotyktu in the black

The US approval of Bristol Myers Squibb’s Tyk2 inhibitor deucravacitinib, now branded Sotyktu, will almost certainly put pressure on the rival oral psoriasis product Otezla given Sotyktu's better-than-expected label. There had been concerns that, with Tyk2 a member of the Jak family, the FDA might have taken an ultra-cautious view on safety; however, the much-feared black box warning and onerous testing requirements did not emerge, and many are predicting that Sotyktu could dominate the oral market for new psoriasis patients soon after its September launch, notwithstanding its $75,000 list price. The wider significance of Sotyktu’s approval is the potential shift towards more efficacious oral psoriasis options and the validation of Tyk2 as a target. Other Tyk2 inhibitors waiting in the wings include Nimbus’s NDI-034858 and Ventyx’s VTX958; the latter's stock soared 69% today. Privately held Nimbus, which today raised $125m, has the next most-advanced Tyk2 inhibitor, in phase 2, but has previously reported issues with neutropenia, lipid abnormalities and CPK elevation. Meanwhile, developers of other oral psoriasis options outside Tyk2, such as Dice Therapeutics and Immunic, saw their stock sink.

Selected clinical-stage Tyk2 inhibitors for psoriasis
Product/project Company Status
Sotyktu Bristol Myers Squibb Approved - launch September 2022
NDI-034858  Nimbus Therapeutics Ph2 - data expected Q4 2022/Q1 2023
VTX958 Ventyx Biosciences Ph1 - ph2 trials due to start Q4 2022
GLPG-3667 Galapagos Ph1 - ph2 trials due to start in 2022
ESK-001 Alumis Ph1 - primary completion date Dec 2022
ICP-488 Innocare Ph1 - primary completion date Jan 2023
Source: Evaluate Pharma, & company statements.

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