PrimegeGene announced on September 12, 2023, that the Company's self-developed Class 1 new drug PG-011 Gel (Pemetrexedinib Gel) has successfully completed the Phase II clinical study for the treatment of nodular itchy rash, meeting the expected goal, which marks another new progress in the field of topical medication for the treatment of immune-inflammatory diseases, and shows that Pemetrexedinib Gel is an excellent therapeutic agent in the areas of anti-inflammation, itch-relief, and immune regulation. Pramoxetinib PrimegeGene has developed its own JAK inhibitor, which has been approved for clinical trials in a number of indications, and is at the forefront of clinical research on topical pramoxetinib for the treatment of nodular itchy rash.
Prurigo Nodularis (PN) is a common and difficult-to-treat chronic inflammatory dermatosis, which is characterized by intense itching and repeated scratching, resulting in multiple, hyperkeratotic nodular lesions.The etiology and mechanism of PN are related to immune function, neurological factors, sweat gland function, psychology, and other factors. Intense itching and skin lesions coupled with anxiety and emotional depression caused by the disease have a significant impact on the patient's quality of life and produce a high burden of disease.
There is a lack of effective clinical treatments for the disease. In recent years, only Dupilumab (Dupilumab) has been approved for the treatment of the disease, and other treatment modalities include topical glucocorticoids or tar-based agents for localized treatment, as well as antihistamines and sedative and sleeping drugs for systemic treatment, etc. The clinic is in urgent need of medications that can effectively treat Nodular Itchy Rash, in particular, innovative topical or systemic therapeutic medications that can alleviate the symptoms of the itchy rash.
The Phase II clinical study of pemetrexedinib gel for the treatment of nodular itchy rash is an exploratory clinical trial led by Prof. Lu Qianjin of the Institute of Dermatology, Chinese Academy of Medical Sciences. Adult patients with mild to moderate nodular itchy rash were enrolled in this study to evaluate the efficacy, safety and pharmacokinetic profile of pramoxetinib gel for 4 weeks of treatment.
The results of the study showed that after 4 weeks of treatment with topical pemetrexedinib gel administered three times daily, the proportion of subjects achieving clinically meaningful reduction in itching and the proportion of subjects with significant reduction in nodule size in the treatment group was significantly better than that in the placebo group, demonstrating a favorable therapeutic effect. In terms of safety, Pemetrexedinib Gel demonstrated a favorable systemic and local safety profile and was well tolerated, with minimal systemic blood entry. Based on the results of this study, PrimegeGene will formulate the next step in its clinical development strategy to confirm the clinical efficacy and safety of pemetrexedinib gel for the treatment of PN, to provide new treatment options for patients with nodular itchy rash, and to address unmet clinical needs.