GEN Announces Positive Phase 2 Clinical Trial Results for GN-037 Topical Cream in Patients with Mild to Moderate Plaque Psoriasis
Ankara, Türkiye, September 25, 2024 – GEN Pharmaceuticals (GENIL.IS), a leading Turkish pharmaceutical company, has announced the positive results of its Phase 2 clinical trial evaluating the safety and efficacy of its investigational drug, GN-037 topical cream, in treating mild to moderate plaque psoriasis. The findings were presented at Amsterdam’s European Academy of Dermatology and Venereology (EADV) 2024 Congress.
This multicenter, randomized, double-blind, placebo-controlled Phase 2 study involved 190 patients across 19 clinical centers in Türkiye. Patients were treated with GN-037, clobetasol 17-propionate, or placebo twice daily for four weeks, followed by an additional four-week observation period. The study demonstrated GN-037’s statistically significant superiority in reducing psoriasis symptoms compared to placebo, positioning it as a promising new treatment option for psoriasis patients worldwide.
Key Findings:
- GN-037 Phase 2 trial met the primary endpoint: treatment successdefined as the % of patients with at least a 2-grade improvement in Investigator’s Global Assessment (IGA) score and achieving an IGA score of 0 or 1.
- 37.9% of patients treated with GN-037 achieved treatment success at week 4 compared to 9.1% in the placebo group (P=0.006).
- GN-037 demonstrated significant improvements in the reduction of erythema (57.6%, P=0.008), plaque elevation (72.7%, P=0.001), and scaling (80.3%, P=0.006) compared to placebo.
- 31.8% of patients in the GN-037 group achieved at least a 75% reduction in PASI, compared to 6.1% in the placebo group (P=0.009).
- No new safety concerns emerged with similar treatment-emergent adverse events across all arms.
Abidin Gülmüş, Chairman of GEN, stated:
“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.”
Nadir Ulu, MD, PhD, Vice President of R&D, added:
“Our Phase 2 trial results highlighted GN-037’s potential to improve patient outcomes significantly, and it may provide a novel, well-tolerated treatment option for patients with mild to moderate plaque psoriasis.”
About Plaque Psoriasis
Plaque psoriasis is a chronic and recurrent skin disease affecting approximately 1.3 million people in Türkiye and 125 million globally. Most cases require topical treatment, and GN-037 aims to address the unmet needs of patients with mild to moderate forms of the disease.
About GEN:
Founded in 1998, GEN is Türkiye’s leading speciality pharmaceutical company. It is focused on developing innovative therapies across multiple therapeutic areas, with significant R&D investments and a commitment to advancing global healthcare. GEN actively works in both in-licensing and out-licensing business models. GEN partners with leading global pharmaceutical companies to bring innovative therapies and rare solutions to communities in its countries. It also develops and produces highly demanded and competitive therapeutic products in its GMP-certified manufacturing facility to bring therapy solutions required in international markets.
