A phase 3 trial of InventisBio’s nomelcitinib has hit its primary endpoint, delivering evidence that the TYK2 inhibitor can hold its own against rival psoriasis drugs.
Shanghai-based InventisBio randomized 391 people in China to receive one of two nomelcitinib regimens or placebo. At Week 16, more than 70% of patients in the two treatment arms had experienced at least a 90% improvement on the Psoriasis Area Severity Index (PASI). InventisBio has yet to share placebo data, but the biotech said nomelcitinib performed “significantly” better than the control, achieving the trial's primary endpoint.
The PASI 90 rate, which is in line with the phase 2 result, looks competitive. Cross-trial comparisons can be unreliable, particularly when comparing Chinese trials to global studies, but the PASI 90 rate is higher than those reported for rival TYK2 drugs in development at Takeda and Alumis.
Takeda linked its TYK2 inhibitor zasocitinib to PASI 90 rates of 61.3% and 51.9% at Week 16 of its phase 3 trials. Alumis reported (PDF) PASI 90 rates of 59.9% and 53.1% at Week 16 of its phase 3 envudeucitinib trials. Meanwhile, Johnson & Johnson and Protagonist Therapeutics’ oral L-23 receptor antagonist Icotyde achieved (PDF) PASI 90 rates of 50% to 55% in the two adult trials supporting its FDA approval.
InventisBio reported a hit on a key secondary endpoint looking at the proportion of patients with clear or almost clear skin at Week 16. More than 80% of people receiving nomelcitinib met the response criteria, significantly outperforming placebo. Again, InventisBio’s data look competitive versus results shared by Alumis, J&J and Takeda.
No new safety signals emerged in the study, keeping InventisBio on course to deliver data that could support approvals in multiple indications. The biotech started another phase 3 trial in China in January to compare its drug candidate to Bristol Myers Squibb’s TYK2 inhibitor Sotyktu, a benchmark that J&J and Takeda have already beaten. InventisBio is running a phase 2 psoriasis trial in the U.S.
InventisBio has global rights to nomelcitinib and the biotech’s Chinese R&D program includes phase 2 clinical trials in ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus and vitiligo. This range reflects the broad therapeutic potential of TYK2 inhibitors, which has in turn attracted high valuations for the class, including when Takeda paid $4 billion upfront for zasocitinib in 2022.
The most exciting areas of biopharma R&D is among the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:
