GEN initiates Phase 1 study of the first-in-class investigational drug SUL-238

GEN initiates Phase 1 study of the first-in-class investigational drug SUL-238

Ankara, Türkiye – GEN, a leading specialty pharmaceutical company in Turkey with its GMP certified Manufacturing Facility and R&D centers, announced that the first SUL-238 dosing in Phase 1 clinical trial in healthy volunteers was carried out on February 19, 2024. Formulation and R&D stability studies of the investigational products used in the Phase 1 clinical trial were conducted in GEN R&D Laboratories and produced in the GEN Manufacturing Facility.

Abidin Gülmüş, Founder & CEO of GEN, said: “As GEN, in line with our innovation and global growth strategies, we are thrilled to reach out to the next chapter of our journey of developing a novel oral therapeutic, SUL-238, to offer a solution to the patients living with Alzheimer’s Disease and neurodegenerative diseases across the globe.”

Nadir Ulu, MD, PhD, Vice President (R&D and Clinical Operations) of GEN, said: “We are proud to announce that the first healthy volunteer has been dosed in our GN-001 trial. This marks a remarkable milestone for 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 people with neurodegenerative diseases. We are grateful for the support from the healthy volunteers and clinical trial investigators”.

About SUL-238

SUL-238 is a unique small molecule designed to target the ‘powerhouse’ of the cell, the mitochondria, and improve its function during disease. Mitochondrial dysfunction plays a significant role in the development of several acute and chronic diseases. Positive preclinical proof of concept has been obtained in animal models for Alzheimer’s Disease (AD) and other diseases such as Heart Failure (HF), Chronic Kidney Disease (CKD), Pulmonary Arterial Hypertension (PAH), Acute Kidney Injury (AKI) and Sepsis. Besides the proof of concepts, SUL-238 has been extensively investigated in safety tests according to the guidelines of drug regulatory authorities such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

About Alzheimer’s Disease

Alzheimer’s Disease is a devastating, progressive disorder that results in memory loss and other cognitive impairments. There is currently no treatment available that can cure or even halt the progressive course of Alzheimer’s Disease. Consequently, Alzheimer’s Disease features on the priority medicines list of the World Health Organization.

Mitochondrial dysfunction and neuroinflammation are present in Alzheimer’s Disease. Although the underlying mechanisms of these pathologic changes remain unclear, possible links between these phenomena have been reported, and it is increasingly recognized that mitochondria or mitochondrial components may contribute to neuroinflammation.