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GEN Announces First Patient Dosed in Phase II Clinical Trial of SUL-238 in Parkinson's Disease
GEN Announces First Patient Dosed in Phase II Clinical Trial of SUL-238 in Parkinson's Disease
Proof-of-concept SHEPHERD study will assess SUL-238's effects on mitochondrial function in patients with Parkinson's disease.
ANKARA, TR / ACCESS Newswire / June 8, 2026 / GEN Pharmaceuticals (GENIL.IS), Türkiye's leading specialty pharmaceutical company, announced today that the first patient has been dosed in its Phase II Proof of Concept Trial for SUL-238 Targeting Mitochondrial Dysfunction in Patients with Parkinson's Disease.
Details of the Phase II trial, entitled "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 (SHEPHERD) can be viewed at clinicaltrials.gov (NCT07322887).
Abidin Gülmüş, Chairman of GEN, stated: "Dosing the first patient in this Phase II trial is a pivotal moment for SUL-238 and for the Parkinson's community. There remains a profound unmet need for therapies that can slow or halt disease progression, and we believe SUL-238's mechanism of action - targeting mitochondrial dysfunction at the core of the disease - positions it as a potentially transformative approach."
Nadir Ulu, MD, PhD, Chief Scientific Officer, Vice President of GEN, stated: "The initiation of this trial represents a critical proof-of-concept opportunity. By enrolling treatment-naïve patients, we have a unique window to evaluate whether early intervention with SUL-238 can improve mitochondrial function. We thank the participating patients, their families, and the clinical investigators whose commitment makes this research possible."
About Parkinson's Disease
Parkinson's Disease (PD) is the most common neurodegenerative movement disorder affecting up to 2% of those aged above 60 years, with incidence expected to double by 2040. The disease follows a progressive course and despite decades of research, currently available treatments remain symptomatic and do not modify the underlying course of disease. Mitochondrial dysfunction and oxidative damage are implicated in the pathophysiology of neurodegenerative disorders including PD and Alzheimer's disease. Since mitochondria are highly multifunctional organelles, their integrity is essential for neuronal function and survival.
About SUL-238
SUL-238 is a novel, first-in-class, hibernation-inspired small molecule designed to target mitochondria, the 'powerhouse' of the cell. SUL-238 supports mitochondrial bioenergetics via complex I/IV activation and enhances mitochondrial function in various preclinical disease models for neurodegenerative, cardiovascular and renal disorders, as well as in accelerated aging. SUL-238 exhibits a favourable pharmacokinetic profile and a high cerebrospinal fluid penetration, and has undergone extensive safety evaluation in preclinical and clinical Phase I studies. GEN licenses SUL-238 from Sulfateq B.V. for neurodegenerative disease applications.
About GEN
Founded in 1998, GEN is Türkiye's leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas. Through significant R&D investments and global collaborations, GEN is committed to advancing healthcare worldwide. The company develops and manufactures high-quality, competitive products at its GMP-certified production facility and continues its bold efforts in original drug development via two dedicated R&D centers.
About Sulfateq
Sulfateq B.V. is a Dutch biotech company in Groningen (the Netherlands) that fosters strategic collaborations with academic and industrial research centres to accelerate the development of innovative new medicines. It has developed a novel class of small molecule SUL-compounds that maintain mitochondrial health.
For more information:
www.genilac.com.tr
www.sulfateqbv.com
Press Contacts:
Bulutay GÜNEŞ, Sr. Head of Corporate Brand
[email protected]
Fatih GÖREN, Investor Relations Manager
[email protected]
Kees van der Graaf, Chief Executive Officer
[email protected]
SOURCE: GEN Ilac ve Saglik Urunleri A.S.
View the original press release on ACCESS Newswire
(A.Moore--TAG)
