GEN Reports Positive Phase 2 Results for GN-037 Cream in Mild to Moderate Plaque Psoriasis

ANKARA, TURKEY – GEN Pharmaceuticals, a prominent Turkish pharmaceutical company, recently shared encouraging outcomes from its Phase 2 clinical trial of GN-037 topical cream, for the treatment of mild to moderate plaque psoriasis. The results were disclosed at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam.

The rigorous Phase 2 study, executed across 19 clinical sites in Türkiye, was multicenter, randomized, double-blind, and placebo-controlled. It included 190 participants who were assigned to receive either GN-037, clobetasol 17-propionate, or a placebo. Treatments were administered twice daily over four weeks, followed by an observational period of an additional four weeks. The trial's outcomes demonstrated that GN-037 significantly outperformed the placebo in alleviating psoriasis symptoms, suggesting it could be a promising treatment option for patients worldwide.

Key data from the trial indicated that GN-037 achieved its primary endpoint of treatment success, defined as the percentage of participants experiencing at least a 2-grade improvement in the Investigator’s Global Assessment (IGA) score and reaching an IGA score of 0 or 1. By the fourth week, 37.9% of those treated with GN-037 achieved this treatment success, contrasted with 9.1% in the placebo group, a statistically significant difference (P=0.006).

Additionally, GN-037 showed superior performance in addressing specific psoriasis symptoms. About 57.6% of GN-037 recipients experienced significant reductions in erythema (P=0.008), 72.7% saw improvements in plaque elevation (P=0.001), and 80.3% benefited from reduced scaling (P=0.006) compared to placebo users. Furthermore, 31.8% of the GN-037 group achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI), in contrast to 6.1% in the placebo group (P=0.009).

The safety profile of GN-037 was consistent with expectations, as no new safety issues arose, and the occurrence of treatment-emergent adverse events was similar across all study groups.

Abidin Gülmüş, Chairman of GEN Pharmaceuticals, expressed his enthusiasm over the trial's success, stating, “We are thrilled to announce the positive results of our Phase 2 clinical trial. We believe GN-037 offers new hope for the global psoriasis community.” Similarly, Nadir Ulu, MD, PhD, Vice President of Research and Development, noted the significant potential of GN-037 to enhance patient outcomes, highlighting its promise as a novel and well-tolerated treatment alternative for individuals with mild to moderate plaque psoriasis.

GEN Pharmaceuticals, established in 1998, is Türkiye’s foremost specialty pharmaceutical company. It is dedicated to developing groundbreaking therapies across various therapeutic fields. The company places a strong emphasis on research and development, evidenced by substantial investments aimed at advancing global healthcare. GEN's operational strategy includes collaborations with leading international pharmaceutical firms to introduce innovative treatments and rare solutions to diverse communities. Additionally, GEN manufactures high-demand therapeutic products in its GMP-certified facility, catering to both domestic and international markets.

With the promising results from this clinical trial, GN-037 could potentially become a new standard in the treatment of mild to moderate plaque psoriasis, offering relief to patients worldwide.