New Hope for the Treatment of Parkinson's Disease

• First patient treated in Phase II clinical trial of GEN's innovative drug candidate SUL-238 in Parkinson's patients. • SHEPHERD study will evaluate the effects of SUL-238 on mitochondrial function in Parkinson's disease. • SUL-238 stands out as a next-generation molecule targeting mitochondria, developed drawing inspiration from hibernation mechanisms. GEN Pharmaceutical and Health Products Inc. (GENIL.IS) announced that the first patient has been treated in the Phase II clinical trial of SUL-238, an innovative drug candidate targeting mitochondrial dysfunction in Parkinson's patients. The Phase II proof-of-concept study, named "SHEPHERD," will evaluate the effects of SUL-238 on high energy phosphates in early-stage, treatment-naive Parkinson's patients using magnetic resonance spectroscopy (31P-MRS). The study aims to demonstrate the drug's effects on the biological mechanisms underlying the disease. GEN Board Chairman Abidin Gülmüş made the following statement on the matter: "The treatment of the first patient in our Phase II clinical trial represents an extremely significant milestone for both the SUL-238 development program and individuals living with Parkinson's disease. There is a major unmet need for therapies that could slow or halt disease progression in Parkinson's disease. We believe SUL-238's innovative mechanism of action, targeting mitochondrial dysfunction believed to underlie the disease, has the potential to offer a transformative approach in this field." Dr. Nadir Ulu, GEN Deputy General Manager (Medical, Research & Development and Clinical Operations), highlighted the importance of the study: "This study provides a critical proof-of-concept opportunity for SUL-238. The inclusion of treatment-naive patients in the research creates an important opportunity to evaluate the potential of early intervention to improve mitochondrial function. We extend our gratitude to all patients, family members and researchers who have contributed to the implementation of this study." Details of the study titled "A Phase II, Randomized, Double-blind, Placebo-Controlled, Single-Center Study to Assess the Effects of SUL-238 on High Energy Phosphates with Magnetic Resonance Spectroscopy (31P-MRS) in Patients with Early, Untreated Parkinson's Disease" can be accessed on the ClinicalTrials.gov platform under number NCT07322887. **Unmet Treatment Need in Parkinson's Disease Continues** Parkinson's disease affects approximately 2 percent of individuals over 60 years of age and is considered one of the most common neurodegenerative movement disorders worldwide. Due to the progressive nature of the disease, current treatments focus primarily on symptom control, while the need for new therapeutic options that could alter disease progression continues. Scientific research demonstrates that mitochondrial dysfunction and oxidative damage play an important role in the development of neurodegenerative diseases such as Parkinson's and Alzheimer's. Protection of mitochondria, which lie at the center of cellular energy production, is critical for healthy neuronal function and survival. **Innovative Molecule Inspired by Hibernation: SUL-238** SUL-238 is an innovative small-molecule drug candidate targeting mitochondria, developed drawing inspiration from the metabolic resilience mechanisms of hibernating organisms. The molecule, which aims to improve impaired mitochondrial function by supporting cells' energy production capacity, has shown promising results in neurodegenerative, cardiovascular and renal disease models as well as in aging research. SUL-238, which has the ability to cross the blood-brain barrier, has had its safety profile comprehensively evaluated in preclinical studies and Phase I clinical trials. **About GEN** With over 25 years of experience, GEN is one of Turkey's fastest-growing pharmaceutical companies. Developing solutions for rare diseases and unmet healthcare needs, the company develops and manufactures globally competitive products through strong international business partnerships as well as advanced technology manufacturing infrastructure and research & development investments. **About Sulfateq** Netherlands-based biotechnology company Sulfateq BV is accelerating innovative drug research through strategic collaborations with academic and industrial research institutions. The company continues its work on next-generation small-molecule agents called SUL compounds, aimed at protecting mitochondrial health.