R&D Projects

GN-037 Project

The Phase II clinical trial for GN-037, an innovative investigational topical cream developed in GEN R&D laboratories and intended for the treatment of mild to moderate plaque psoriasis, was conducted throughout 2023 to evaluate its clinical efficacy and safety. The results of the completed Phase I study, which preceded the Phase II trials, were presented in the article titled “Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial,” published in the Dermatology and Therapy journal on May 10, 2023. Dermatology and Therapy, a respected journal with international scientific standing, is known for publishing high-quality research on innovative treatments in dermatology. The Phase I clinical study results detailed in this article demonstrate that our investigational product, GN-037, has a favorable safety and tolerability profile. 

SUL-238 Project

The work on our innovative investigational product, SUL-238, which is being developed in collaboration with Sulfateq B.V. from the Netherlands for the potential treatment of Alzheimer’s and other neurodegenerative diseases, has continued during this period. SUL-238 has demonstrated the ability to prevent the development of Alzheimer’s disease and improve memory functions in experimental Alzheimer’s disease models in a dose-dependent manner. It has been shown to be safe in preclinical animal studies conducted according to European Medicines Agency (EMA) guidelines, including GLP and non-GLP toxicity studies. 

In the clinical research phase of this project, SUL-238 will first be investigated for safety and pharmacokinetics in a single-dose and multiple-dose Phase I clinical trial. Following successful completion of this phase, SUL-238 is expected to demonstrate improvements in cognitive functions by reversing or preventing the progression of impaired mitochondrial function in brain cells of Alzheimer’s patients in Phase II and Phase III clinical trials. 

For this purpose, the necessary formulation and R&D stability studies for the Phase I trial have been successfully completed in GEN R&D laboratories. Clinical research products for this Phase I trial have been produced at GEN Manufacturing Facility, and the relevant approval processes for the Phase I clinical trial have been initiated. An application has been made for the TÜSEB – Clinical Research Projects Call for Drug Development, which has a funding limit of 60 million TL, for the Phase I clinical trial.