GEN Begins Phase 1 Clinical Trial of SUL-238
GEN announced that it has initiated a Phase 1 clinical trial with healthy volunteers of SUL-238, an innovative investigational drug intended for use in the treatment of Alzheimer and other neurodegenerative diseases.
GEN has begun a Phase 1 clinical trial with healthy volunteers for SUL-238, a first-in-class innovative investigational drug. Starting its work in 2021 in collaboration with Netherlands-based biotechnology company Sulfateq BV, GEN announced that the first dose of SUL-238, intended for use in the treatment of Alzheimer's disease and other neurodegenerative diseases, was administered on 19 February 2024.
The formulation and R&D stability studies of the investigational products to be used in the Phase 1 clinical trial of SUL-238 were conducted in GEN's R&D laboratories, and the clinical research products to be used in this study were manufactured at GEN's production facilities.
Abidin Gülmüş, Chairman of the Board and General Manager of GEN, speaking about the excitement and pride of signing an important study towards the treatment of Alzheimer's disease, continued as follows:
"As a dynamic player in Turkey's pharmaceutical industry, in line with our innovation and global growth strategies, we are excited to reach the next step in our journey to develop SUL-238, a new oral therapy to provide solutions for Alzheimer's disease and other neurodegenerative diseases. We know that this special study we are conducting is an important step that will benefit our country and humanity, and we continue our work with this sense of responsibility."
Nadir Ulu, Deputy General Manager of R&D and Clinical Operations at GEN, made the following statement:
"We are proud to announce that the first dose of the drug has been administered to the first healthy volunteer in our GN-001 study. This is an important milestone for both the GEN and Sulfateq teams and for the SUL-238 development program in Alzheimer's disease and other neurodegenerative diseases.
We look forward to continuing our efforts to develop SUL-238 as a potential treatment option for individuals with neurodegenerative diseases. We are grateful for the support we have received from healthy volunteers and the researchers involved in our clinical trial."
SUL-238 is a unique small molecule that targets mitochondria, the cell's 'power plant', and is designed to enhance mitochondrial function during the disease process. Mitochondrial dysfunction plays an important role in the development of many acute and chronic diseases. Positive preclinical proof-of-concept findings have been obtained in experimental animal models for Alzheimer's Disease (AD) and heart failure (HF), chronic kidney disease (CKD), pulmonary arterial hypertension (PAH), acute kidney injury (AKI) and sepsis, among other diseases. In addition to proof-of-concept studies, SUL-238 has been extensively investigated through safety testing conducted in accordance with guidelines of drug authorities such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
GEN is one of Turkey's fastest-growing pharmaceutical companies with over 25 years of experience. With a diversified business model, GEN both provides global solutions to rare diseases and unmet health needs with strong global partners and develops and manufactures competitive products in high demand in the international market with state-of-the-art production facilities and significant R&D investments that meet the highest standards.
As one of the few pharmaceutical companies included in the Turquality program, GEN makes bold R&D investments with the aim of becoming an important global player in the pharmaceutical sector and continues its original drug development activities in two different R&D centers with its strong infrastructure. Serving with expert staff in its offices in Turkey, Germany, Russia, Kazakhstan, Uzbekistan, Azerbaijan and Georgia, GEN continues to accelerate its progress in acting in light of ethical and scientific principles, producing innovative solutions and growing toward the goal of becoming the healthcare company of the future.
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