HANGZHOU, China, Aug. 9, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of atopic dermatitis.
The study was a randomized, double-blind, placebo-controlled, multicenter Phase II trial conducted in adult patients (aged 18-75) with moderate-to-severe atopic dermatitis (AD) who had previously received inadequate response to topical treatment for AD or had previously received other systemic treatment for AD. The study was led by Professor Jianzhong Zhang, Director of the Dermatology Department at Peking University People's Hospital. A total of 150 patients were enrolled in the trial. The patients were randomly divided into three trial groups at a ratio of 1:1:1, namely LNK01001 high-dose, low-dose, and placebo groups. The primary efficacy endpoint of the study was the percentage change from baseline in the eczema area and severity index (EASI) score at Week 12.
Preliminary data showed that after 12 weeks of treatment, patients in both the high and low dose groups showed significant improvement, with a statistically significant difference in the percentage change from baseline in EASI score compared to the placebo group, achieving the primary endpoint. Additionally, the proportion of responders achieving EASI-75 (≥75% improvement from baseline in EASI score) and Investigator's Global Assessment (IGA) response[1] were significantly higher in both high and low dose groups of LNK01001 compared to the placebo group. Improvement of pruritus is an important indicator of quality of life for patients with atopic dermatitis, and the results of the trial showed that LNK01001 had a rapid onset of improvement in pruritus, with both the high and low dose groups of LNK01001 showing significantly better improvement in pruritus indices than the placebo group at 24 hours after dosing.
In terms of safety, both high and low dose groups of LNK01001 demonstrated good overall tolerability, with comparable rates of CTC grade 2+ treatment-emergent adverse events (TEAE) and serious adverse events (SAE) compared to the placebo group. No major adverse cardiovascular events (MACE), venous thromboembolism (VTE), malignancies, or severe infections were reported.
Professor Jianzhong Zhang, the principal investigator of this study, the 13th Director in the Dermatology Division of the Chinese Medical Association and Director of the Dermatology Department at Peking University People's Hospital, said, "Atopic dermatitis is a disease characterized by chronic, recurrent pruritus and polymorphic inflammatory skin lesions. Controlling itch and clearing skin lesions are the most urgent treatment needs for AD patients. The results of this study suggest that LNK01001 has the potential to provide clinical benefits to adult patients with moderate to severe AD. We will continue to conduct further research and look forward to validating the efficacy and safety of LNK01001 in Phase III clinical trials to benefit more patients."
"With social development and lifestyle changes, the number of atopic dermatitis patients is increasing, with a global population of 390 million. We are pleased to see that LNK01001 has shown positive results in the treatment of atopic dermatitis", said Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, "We are preparing to submit an application for the End of Phase II (EOP2)/Pre-Phase III meeting to advance the clinical development of this compound and strive to benefit more patients as soon as possible."
Note: [1]: IGA response is defined as achieving an IGA score of 0 or 1 (complete or near-complete clearance of skin lesions) and an improvement of ≥2 points from baseline.
About Lynk Pharmaceuticals:
Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed several innovative new drugs and successfully completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.