
Lattice miss is grating for Bristol Myers
Why deucravacitinib would fail in ulcerative colitis when it succeeded convincingly in psoriasis is not clear, but fail it has. In the phase 2 Lattice-UC study Bristol Myers Squibb’s oral Tyk2 inhibitor did not show improved clinical remission over placebo in moderate to severe UC. Neither did the trial meet its secondary efficacy endpoints. Deucravacitinib might still have a chance in the condition: a second phase 2 trial testing a higher dose is under way, and could report imminently. But hopes in UC will surely dim, not least because Pfizer has already discontinued its Tyk2, PF-06826647, in the disease. Perhaps deucravacitinib is a better bet in the various other disorders in which it is being trialled, though for now psoriasis remains the only indication for which analysts are forecasting sales – $2.4bn in 2026, according to Evaluate Pharma. The news will hardly help shore up confidence in Bristol’s biggest pipeline hope, which has already been dented by regulatory concerns. The company’s shares have slid heavily since the FDA slapped surprisingly stringent warnings on the related Jak-inhibitor class, with investors fearful that the regulator might consider the Tyk2 mechanism to carry similar risks.
Selected clinical-stage projects targeting Tyk2 | |||
---|---|---|---|
Project | Company | Status | Trial details |
Deucravacitinib (BMS-986165) |
Bristol Myers Squibb | Psoriasis (ph3) | Poetyk-PSO-1 (NCT03624127) and Poetyk-PSO-2 (NCT03611751) hit |
Psoriatic arthritis (ph3) | NCT04908202 and NCT04908189, end 2023 | ||
Ulcerative colitis (ph2) | Lattice-UC (NCT03934216) failed; IM011-127 (NCT04613518) ends 2021 | ||
Crohn's disease (ph2) | NCT03599622, ends 2023 | ||
Lupus nephritis (ph2) | NCT03943147, ends 2023 | ||
Systemic lupus erythematosus (ph2) | NCT03920267, ends 2023 | ||
PF-06826647 | Pfizer | Psoriasis (ph2) | NCT03895372, completed by no results reported |
Hidradenitis suppurativa (ph2) | NCT04092452, ends 2022 (includes brepocitinib & PF-06650833 arms) | ||
Topical brepocitinib (PF-06700841)* |
Pfizer | Atopic dermatitis (ph2) | NCT03903822, hit Mar 2021 |
Psoriasis (ph2) | NCT03850483, ends 2021 | ||
Oral brepocitinib (PF-06700841)* |
Pfizer | Psoriatic arthritis (ph2) | NCT03963401, completed but no results reported |
Systemic lupus erythematosus (ph2) | NCT03845517, ends 2022 | ||
Hidradenitis suppurativa (ph2) | NCT04092452, ends 2022 (also includes PF-06826647 & PF-06650833 arms) | ||
Vitiligo (ph2) | NCT03715829, completed, no results (also includes ritlecitinib (PF-06651600) arm) | ||
Crohn's disease (ph2) | NCT03395184, ends 2022 (also includes ritlecitinib (PF-06651600) arm) | ||
NDI-034858 | Nimbus^ | Plaque psoriasis (Ph2) | NCT04999839, ends 2022 |
OST-122** | Oncostellae | Ulcerative colitis (ph1/2) | NCT04353791, ends 2022 |
ICP-332 | Innocare | Ph1 in healthy volunteers | Trial begun in China |
BMS-986322 | Bristol Myers Squibb | Ph1 in healthy volunteers | NCT04175925, recruitment on hold owing to Covid-19 |
Notes: *also hits Jak1; **also hits Jak3 & ARK5; ^Bristol Myers Squibb has option via Celgene acquisition. Sources: Evaluate Pharma, clinicaltrials.gov. |