Study Results of Novel TYK2 Inhibitor Soficitinib in Patients with AD Published by JAMA Dermatology
MWN-AI** Summary
On January 29, 2026, JAMA Dermatology published promising results from a Phase II study assessing the efficacy and safety of soficitinib (ICP-332), a novel TYK2 inhibitor, in treating moderate-to-severe atopic dermatitis (AD). This double-blind, placebo-controlled trial involved 75 participants who were randomly assigned to receive either soficitinib at doses of 80 mg or 120 mg, or a placebo, taken orally once daily.
The study's primary endpoints focused on safety and efficacy, specifically examining the percentage change from baseline in the Eczema Area and Severity Index (EASI) at week 4. Results indicated significant improvements, with the 80 mg group showing a 78.2% improvement in EASI, the 120 mg group a 72.5% improvement, and the placebo group only a 16.7% improvement. Both soficitinib doses also achieved a notably higher EASI-75 response rate of 64% compared to a 56% response from placebo. The treatment also led to greater percentages of patients achieving scores of clear or almost clear on the Validated Investigator Global Assessment, specifically in the 80 mg group.
Patients experienced rapid relief from pruritus, with substantial reductions in pruritus severity and frequency observed by day 2, and further improvements peaked at week 4. The study found that 72% of patients in the soficitinib groups improved by four or more points on symptom severity compared to just 16% in the placebo group.
Importantly, soficitinib demonstrated a good safety profile, with most treatment-related adverse events being mild or moderate. Professor Jinhua Xu from Huashan Hospital remarked on the encouraging results, noting the potential for advancing to Phase III trials to further assess soficitinib's benefits for AD patients.
MWN-AI** Analysis
The recent publication of Phase II study results for the novel TYK2 inhibitor soficitinib in JAMA Dermatology presents a compelling investment opportunity in the biopharmaceutical sector. With the drug showcasing significant efficacy and safety in treating moderate-to-severe atopic dermatitis (AD), attention should be directed toward InnoCare, the company behind soficitinib.
The study revealed that patients receiving soficitinib had a substantial improvement in the Eczema Area and Severity Index (EASI), achieving improvements of 78.2% and 72.5% for the 80 mg and 120 mg doses, respectively, compared to only 16.7% for the placebo group. Additionally, the high EASI-75 response rate of 64% for both dosing groups compared to a mere 8% in placebo underlines the drug's potential market appeal.
As InnoCare has completed patient enrollment for a Phase III clinical trial involving 579 patients, anticipation is mounting for the drug’s commercial prospects. Given the prevalence of AD and the current lack of effective therapies, if the Phase III results mirror these promising findings, soficitinib could capture a significant market share.
Investors should monitor developments regarding the drug's progress. Analysts may also want to consider the broader implications of this success across InnoCare's pipeline, particularly as the company is exploring soficitinib's application in other autoimmune conditions, including vitiligo.
In summary, soficitinib stands at the forefront of a transformative solution in dermatology, supported by promising clinical data. As safety and efficacy signals remain strong, stakeholders may find favorable opportunities within InnoCare, leading to potential growth in share value as the company moves closer to commercialization. However, investors should remain cognizant of the inherent risks within clinical development as future results unfold.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
BEIJING, Jan. 29, 2026 (GLOBE NEWSWIRE) -- JAMA Dermatology recently published the results of a Phase II study of novel TYK2 inhibitor soficitinib (ICP-332) in patients with moderate-to-severe atopic dermatitis (AD). The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD.
This is a double-blind, placebo-controlled, phase 2 randomized clinical trial aiming to evaluate the safety and efficacy of soficitinib for moderate to severe AD. 75 participants were randomized 1:1:1 to receive soficitinib at 80 mg or 120 mg, or placebo orally once daily. The primary endpoint was safety and efficacy. The key efficacy endpoint was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other endpoints included percentages of patients achieving EASI-75 (a ?75% improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with 2 or more points improvement.
Soficitinib achieved multiple efficacy endpoints in the study. Percentage improvement from baseline in EASI at week 4 were 78.2% in the 80-mg soficitinib group, 72.5% in the 120-mg soficitinib group, and 16.7% for those receiving placebo. There was a statistically significant higher EASI-75 response rate with both soficitinib doses (64.0% for each; difference vs placebo, 56.0%) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and improvement of 2 or more points at week 4 in the 80-mg soficitinib group vs placebo (36.0%; difference vs placebo, 32.0%, P=0.005).
Meanwhile, soficitinib demonstrated rapid relief of pruritus and significant improvement in quality of life. Substantial reductions in Pruritus NRS severity and frequency scores were observed on day 2 of treatment compared to placebo, with continued improvement over time peaking at week 4 in severity and in frequency (all P<0.05). In both the 80-mg soficitinib and 120-mg soficitinib groups, 18 of 25 patients (72.0%) achieved an improvement of 4 points or more at week 4, compared with 4 of 25 patients (16.0%) in the placebo group (P<0.0001). DLQI from baseline in the soficitinib groups were considerably better than those in the placebo group at weeks 1, 2, and 4.
Soficitinib also showed a good tolerability and safety profile, and treatment-related adverse events (TRAEs) were mild or moderate. All TEAEs in the 80-mg soficitinib group were mild, which is comparable to those receiving placebo.
Professor Jinhua Xu of Huashan Hospital Fudan University said, “In this Phase II randomized clinical trial, soficitinib monotherapy was efficacious and demonstrated a favorable benefit-risk profile. I am delighted that patient enrollment has been completed for the Phase III clinical trial of soficitinib in AD and look forward to benefiting patients as early as possible.”
JAMA Dermatology is a leading international academic journal published by the American Medical Association (AMA), focusing on cutting-edge research in dermatology.
Note: The main content of this press release is derived from this published article. Full text can be found in https://jamanetwork.com/journals/jamadermatology/fullarticle/2843770.
About Soficitinib
Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, psoriasis, and more. Patient enrollment has been completed for the Phase III clinical trial of soficitinib in moderate-to-severe AD, with a total of 579 patients enrolled; enrollment has also been completed for the Phase II clinical trial of soficitinib in vitiligo, with a total of 162 patients enrolled.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
InnoCare Forward-looking Statements
This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
Contact
| Media | Investors |
| Chunhua Lu | |
| 86-10-66609879 | 86-10-66609999 |
| chunhua.lu@innocarepharma.com | ir@innocarepharma.com |
FAQ**
How does InnoCare Pharma INCPF plan to leverage the favorable safety profile and efficacy results from the Phase II study of soficitinib to attract investors for its upcoming Phase III clinical trial?
What strategies does InnoCare Pharma INCPF have in place to ensure successful commercialization of soficitinib, especially considering its promising results in moderate-to-severe atopic dermatitis?
Given the completion of patient enrollment for both the Phase III trial of soficitinib in atopic dermatitis and the Phase II trial in vitiligo, how does InnoCare Pharma INCPF prioritize these developments in terms of future funding and resource allocation?
How might the results of the Phase II study impact the overall market position of InnoCare Pharma INCPF in the dermatology sector, particularly against competitors developing similar TYK2 inhibitors?
**MWN-AI FAQ is based on asking OpenAI questions about InnoCare Pharma (OTC: INCPF).
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