Shanghai-based biotech InventisBio’s tyrosine kinase 2 (TYK2) inhibitor nomelcitinib has posted a win in a pivotal psoriasis trial – potentially paving the way for the drug’s debut on an increasingly competitive market.
This late-stage success stems from an ongoing, China-based Phase III study (NCT07130604), in which InventisBio has randomised 391 patients with moderate-to-severe plaque psoriasis to receive one of two doses of nomelcitinib or placebo.
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During this trial, over 70% of patients given nomelcitinib across both treatment groups achieved at least a 90% improvement in the area and severity of their psoriasis at week 16 – meeting the trial’s primary endpoint – while a significantly higher percentage (>80%) taking the drug were deemed ‘clear’ or ‘almost clear’ of psoriasis by researchers through the Physician’s Global Assessment (PGA) versus placebo.
On top of this, the JH2-selective TYK2 inhibitor elicited a rapid response, with a significantly higher proportion of patients given either dose of the drug experiencing improvements in psoriasis severity and symptoms at week four.
Researchers also found nomelcitinib to be safe and tolerable, as they identified no new safety signals linked to the drug’s use in this population.
With this positive data in the bag, InventisBio will now await the results of its second China-based Phase III trial, which is putting nomelcitinib head-to-head with Bristol Myers Squibb’s (BMS) marketed TYK2 inhibitor, Sotyktu (deucravacitinib), in moderate-to-severe psoriasis. The biotech is also running a Phase II psoriasis trial on nomelcitinib in the US.
Competition swells in psoriasis market
InventisBio explores the potential of nomelcitinib as the psoriasis market becomes increasingly competitive, with companies looking to create the next generation of drugs that are more convenient for patients and have a better durability of response than current market leaders such as AbbVie’s Skyrizi (risankizumab), Novartis’ Cosentyx (secukinumab) and Johnson & Johnson’s (J&J) Stelara (ustekinumab).
However, InventisBio will face stiff competition from other players looking to enter the TYK2 arena, as both Takeda and Alumis recently debuted positive data from late-stage global programmes on their respective TYK2 inhibitors, zasocitinib and envudeucitinib.
Nomelcitinib will also have to contend with other drugs currently making their debut on the market, with J&J’s newly approved IL-23-targeting psoriasis pill, Icotyde (icotrokinra), attracting analyst attention for its “biologic-like efficacy” in a once-daily oral format.
According to a forecast in a recent report from GlobalData, the parent company of Clinical Trials Arena, the plaque psoriasis market will reach a value of $30.1bn in 2030.
