As GEN, we announced the positive results of the Phase 2 clinical trial of our investigational drug GN-037 topical cream at the EADV 2024 Congress in Amsterdam.
Our Chairman, Mr. Abidin Gülmüş, shared the following statement regarding the announcement:
“As one of Türkiye’s leading pharmaceutical companies, we are thrilled to announce positive results of our Phase 2 clinical trial in patients with mild to moderate plaque psoriasis. We believe that our novel topical combination cream, GN-037, will offer a solution to the psoriasis community around the globe.”
GEN’s Vice President (R&D and Clinical Operations), Mr. Nadir Ulu, evaluated the clinical trial results with the following remarks:
“Patients diagnosed with plaque psoriasis often face challenging episodes which require treatment with different topical agents, underscoring the need for new treatment options with combination drugs that have the potential to improve patient adherence. We are pleased that our novel topical fixed combination, GN-037 cream, was more effective than placebo in achieving primary and all secondary end points in our Phase 2 clinical trial. The results of our clinical trial is encouraging and build on the sustained positive treatment success in patients with mild to moderate plaque psoriasis. We would like to express our sincere appreciation to those who participate in and conduct this Phase 2 clinical trial and the advisory support we receive from patients and healthcare professionals.”
The topline results of our multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial in which the clinical efficacy and safety of GN-037 topical cream is evaluated in the treatment of mild to moderate plaque psoriasis have been presented at European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam today. Formulation of GN-037 topical cream which is our company’s investigational drug in the clinical development phase was developed by GEN R&D laboratories.
Based on analyzed data from the patients with mild to moderate psoriasis enrolled in this Phase 2 clinical trial, topically applied GN-037 has been proven to be statistically significantly efficacious and superior to placebo.
A total of 190 patients from 19 clinical centers in Turkey were enrolled in this Phase 2 clinical trial. Patients included in this study received GN-037 cream or clobetasol 17-propionate or placebo treatments twice a day, morning and evening, for four weeks. At the end of the four-week treatment period, the patients were followed up for an additional four weeks. GN-037 demonstrated statistically significant superiority over vehicle throughout the study. At week 4, treatment success was achieved in 37.9% of patients in GN-037 arm compared with 9.1% in placebo arm (P=0.006). Treatment success was 29.2% in clobetasol 17-propionate arm (P=0.366). Additionally, GN-037 was also superior to placebo in reducing the signs of erythema, plaque elevation and scaling. At least 2 grade improvement compared to baseline was achieved by 57.6% (erythema, P=0.008 vs placebo), 72.7% (plaque elevation, P=0.001 vs placebo) and 80.3% (scaling, P=0.006 vs placebo) of patients in GN-037 arm. Superiority of GN-037 over placebo was maintained for four more weeks after treatment cessation. Treatment emergent adverse events were similar among the arms and there was no new additional safety concern with the GN-037 cream. In summary, topically applied GN-037 treatment demonstrated an excellent efficacy, safety and tolerability profile in patients with mild to moderate psoriasis.
Psoriasis is a recurrent, chronic skin disease that can occur in various clinical forms. The frequency of psoriasis varies in different societies and geographic regions. Different published studies report that the frequency of psoriasis is 1,5-2% in the general population. 70-80% of psoriasis patients have limited/localized disease and are managed with topical therapy only. In this respect, topical treatment is the most common form of treatment in psoriasis management. Based on the current information it is anticipated that there are approximately 1.300.000 psoriasis patients in Turkey and of these patients 900.000 are treated with topical drugs.
