PhIIb win puts Nimbus one step closer to challenging Bristol Myers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

Nimbus expects to present the data at an upcoming medical conference and start a Phase III study in 2023. The exact benefit will be key as the company goes up against not just Bristol Myers and existing treatments, but a suite of players hawking next-gen approaches to blocking the anti-inflammatory target.

PASI-75 is a common metric in psoriasis trials referring to a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index compared to placebo at 12 weeks. Other endpoints were also met, according to Nimbus.

Bhaskar Srivastava

“Additionally, the consistent safety profile seen in this study reinforces TYK2 inhibitors as a differentiated non-JAK therapeutic class,” said Bhaskar Srivastava, Nimbus’ SVP for clinical development, in a statement.

While TYK2 itself belongs to the JAK family — which has been associated with multiple safety concerns — TYK2 inhibitors have so far skirted the safety issues that plagued JAK inhibitors, a point Bristol Myers also underscored when the FDA granted a clean label for its Sotyktu (deucravacitinib) without a black box warning.

Analysts have pegged Sotyktu, which Bristol Myers touts as an oral option with efficacy close to biologics, as a megablockbuster drug with peak sales in the $3 billion-plus range.

NDI-034858 is a top program out of Nimbus’ computational drug discovery platform. Armed with a recent $125 million raise, Nimbus is also developing the drug in other indications, including active psoriatic arthritis, and is planning trials in autoimmune disorders such as inflammatory bowel disease and lupus.

There’s a bit of a contentious history here, too: Celgene made a deal with Nimbus for the right to acquire its TYK2 programs, before Bristol Myers bought Celgene. At one point, Nimbus filed a lawsuit calling for the termination of the $74 billion megamerger, claiming it would stifle competition — but eventually dropped the suit.

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