#China #Hangzhou #Atopic Dermatitis #Lynk Pharmaceuticals #LNK01004

Introduction to LNK01004 Phase II Results

Lynk Pharmaceuticals Co., Ltd., a cutting-edge company focused on drug development, has made significant strides in their fight against atopic dermatitis (AD) through their innovative topical formulation, LNK01004. On November 19, 2025, the company unveiled key findings from their Phase II clinical trials, which have generated optimism regarding the treatment of moderate-to-severe AD.

Trial Overview

In a randomized, double-blind, vehicle-controlled study, the efficacy and safety of LNK01004, available in 0.3% and 1.0% dosage forms, were evaluated over an 8-week period. Of the 75 adult participants enrolled in the trial, they exhibited a vIGA-AD score of either 3 or 4, while encompassing a BSA (Body Surface Area) involvement ranging between 5% and 35%. Participants self-administered the ointment twice daily, allowing researchers to gauge its impact effectively.

Efficacy Findings

The results were promising. After the 8-week treatment period, both doses of LNK01004 produced notable EASI-75 response rates compared to the vehicle group, particularly among patients older than the average baseline BSA. Specifically, those with BSA greater than or equal to 10% demonstrated response rates of 61.1% and 46.2% for the 0.3% and 1.0% formulations, respectively. In contrast, the vehicle group exhibited a significantly lower response rate of just 20%. Patients with BSA of 20% or more experienced even more pronounced clinical improvements, reinforcing the potential of LNK01004 as a viable therapeutic option for individuals grappling with moderate-to-severe AD.

Safety Profile

From a safety standpoint, the Phase II trials revealed low systemic exposure, showcasing a mean Cmax value of 0.06 ng/mL for the 0.3% group and 0.15 ng/mL for the 1.0% group, which is drastically lower than the human whole-blood IC50. Lynk Pharmaceuticals reported good overall tolerability across both dosages, consistent with earlier trials. Furthermore, all treatment-related adverse effects were categorized as mild or moderate, with no serious adverse events emerging during the study.

Expert Commentary

Dr. Henry Wu, the Chief Development Officer of Lynk Pharmaceuticals, expressed excitement over the Phase II results, emphasizing the efficacy and safety demonstrated in patients suffering from moderate-to-severe AD. He remarked that the data not only highlights LNK01004 as a promising topical JAK inhibitor but also underlines its potential clinical significance across various dermatological applications.

Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, articulated the necessity for improved dermatological treatments, acknowledging that current options frequently involve systemic therapies. He noted that LNK01004, due to its topical nature, minimizes the risk of systemic immunosuppression-related adverse reactions, thus enhancing patient compliance and overall quality of life. He reaffirmed the company's dedication to advancing clinical development for LNK01004 and exploring other potential applications.

Future Perspectives for Lynk Pharmaceuticals

Lynk Pharmaceuticals, established by seasoned experts from prominent pharmaceutical giants, remains committed to creating innovative therapies to address unmet medical needs in immune and inflammatory diseases. Following these encouraging Phase II results, the company is poised to continue developing LNK01004 for atopic dermatitis and beyond, striving to introduce transformative treatment options for individuals yearning for effective management of dermatological conditions. For more insights about their innovative endeavors, visit Lynk Pharmaceuticals.

Conclusion

As Lynk Pharmaceuticals progresses with the development of LNK01004, the results from the recent Phase II clinical trial bring hope not only to those living with atopic dermatitis but also to the broader landscape of dermatological treatments. With an innovative approach and a commitment to patient safety, Lynk Pharmaceuticals stands at the forefront of advancements in the management of inflammatory diseases.