# InventisBio Announces Topline Results of a Phase III Study of Nomelcitinib (TYK2 Inhibitor), Demonstrating Promising Efficacy and Safety in Patients with Moderate to Severe Plaque Psoriasis.

- Link: https://www.thailand-business-news.com/pr-news/inventisbio-announces-topline-results-of-a-phase-iii-study-of-nomelcitinib-tyk2-inhibitor-demonstrating-promising-efficacy-and-safety-in-patients-with-moderate-to-severe-plaque-psoriasis
- Published: 2026-11-02T18:00:00+07:00
- Author: PR Newswire

SHANGHAI, Nov. 2, 2026 /PRNewswire/ — InventisBio Co., Ltd. today announced that
its JH2 selective TYK2 inhibitor nomelcitinib (D-2570) has met both the primary 
endpoint and the key secondary endpoint in a registrational Phase III clinical trial
for the treatment of moderate-to-severe plaque psoriasis, demonstrating clinically
and statistically significant superiority over placebo. This result marks a milestone
in the clinical development of nomelcitinib in the field of psoriasis.

The study is a multicenter, randomized, double-blind, placebo-controlled Phase III
trial designed to confirm the efficacy and safety of nomelcitinib in patients with
moderate-to-severe plaque psoriasis. A total of 391 patients have been enrolled 
and randomly assigned in a 1:1:1 ratio to two nomelcitinib treatment groups or a
placebo group. The primary endpoint is the percentage of patients achieving at least
a 90% improvement from baseline in PASI (Psoriasis Area Severity Index) score (PASI
90) at week 16. The key secondary endpoint is the percentage of patients achieving
PGA (Physician Global Assessment) score of 0 (skin lesion cleared) or 1 (skin lesion
almost cleared) with a reduction of ≥2 points from baseline (PGA 0/1) at week 16.

At week 16, both nomelcitinib treatment groups achieved PASI 90 in over 70% of patients,
significantly higher than the placebo group (p<0.0001). The proportion of patients
reaching PGA 0/1 in the nomelcitinib groups exceeded 80%, also significantly higher
than that in the placebo group (p<0.0001). In analyses of other secondary efficacy
endpoints, the nomelcitinib groups consistently outperformed the placebo group, 
showing both clinically meaningful and statistically significant improvements. Among
patients with moderate-to-severe plaque psoriasis, nomelcitinib demonstrated rapid
onset of action — by week 4, both treatment groups already showed significantly 
higher proportions of patients achieving PASI 90 and PGA 0/1 compared to placebo,
with further improvement observed as treatment continued.

During the study period, nomelcitinib demonstrated a favorable safety profile and
good tolerability, consistent with findings from its earlier Phase II study and 
other JH2 selective TYK2 inhibitors, with no new safety signals identified.

"We are very excited about the topline results of this registrational phase III 
study. This study confirmed the magnitude of improvement in PASI 90 and PGA 0/1 
seen in our earlier Phase II study, while all other secondary efficacy endpoints
maintained significant improvement over the placebo group. Importantly, the safety
profile is matching that of our Phase II study with no new safety signals." said
Ling Zhang, CMO of InventisBio.

In addition to this registrational Phase III trial, another head-to-head Phase III
clinical trial evaluating nomelcitinib for psoriasis is progressing smoothly. This
trial uses deucravacitinib as the active control, and is expected to provide additional
data supporting the efficacy and safety of nomelcitinib in patients with moderate-
to-severe plaque psoriasis. In parallel, a Phase II study in the U.S. for psoriasis
and multiple Phase II studies in China for other indications, including ulcerative
colitis (UC), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), and
vitiligo, are also underway.

About Nomelcitinib (D-2570)

Nomelcitinib is a novel oral selective inhibitor of tyrosine kinase 2 (TYK2), independently
developed by InventisBio, designed for the treatment of autoimmune diseases such
as psoriasis. Nomelcitinib selectively binds to the JH2 pseudokinase domain of TYK2,
inhibiting TYK2 kinase activity and blocking the phosphorylation of STAT proteins
mediated by TYK2-dependent cytokine signaling, thereby suppressing the release of
inflammatory factors and modulating immune responses. Preclinical data indicate 
that nomelcitinib exhibits nearly 1,000-fold selectivity over JAK1, suggesting a
wide therapeutic safety margin in clinical settings. Phase II clinical trial results
for psoriasis showed that, compared with the placebo group, nomelcitinib demonstrated
significant efficacy in clearing skin lesions and improving disease severity at 
week 12, with an overall favorable safety profile and good tolerability.

About InventisBio Co., Ltd.

InventisBio is an innovative drug development company based in China with a global
vision, focusing on major disease areas such as oncology, metabolic disorders, and
autoimmune diseases. Guided by the mission to address unmet medical needs, the company
is committed to developing innovative drugs with independent intellectual property
rights and intended for global markets. The company is striving to provide patients
with safer, more effective, and affordable treatment options.

Leveraging its expertise and talent in target identification, molecular design, 
pharmacology and translational medicine, chemical synthesis and formulation development,
and clinical trial design and execution, the company has established comprehensive
platforms including target evaluation and screening, computer-aided drug design,
high-throughput drug discovery and screening, pharmacokinetics and early toxicology
assessment, and pharmacological evaluation. InventisBio has independently developed
a series of patented innovative targeted therapeutics covering oncological indications
such as non-small cell lung cancer, breast cancer, and colorectal cancer; metabolic
disorders including hyperuricemia and gout; and autoimmune diseases like psoriasis.

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