GEN ฤฐlaรง ve Saฤlฤฑk รrรผnleri A.ล. (GENIL), Parkinson hastalarฤฑnda mitokondriyal fonksiyon bozukluฤunu hedefleyen ilaรง adayฤฑ SUL-238’in Faz II kavram kanฤฑtlama klinik araลtฤฑrmasฤฑnda ilk hastaya tedavi baลlandฤฑฤฤฑnฤฑ duyurdu.
SHEPHERD adlฤฑ klinik araลtฤฑrmasฤฑ, erken evre ve tedavi almamฤฑล Parkinson hastalarฤฑnda SUL-238’in yรผksek enerjili fosfatlar รผzerindeki etkilerini manyetik rezonans spektroskopisi yรถntemiyle deฤerlendirecek.
Yรถnetimden aรงฤฑklamalar
GEN Yรถnetim Kurulu Baลkanฤฑ Abidin Gรผlmรผล, “SUL-238’in Faz II klinik araลtฤฑrmasฤฑnda ilk hastaya doz uygulanmasฤฑ, hem SUL-238 programฤฑ hem de Parkinson hastalฤฑฤฤฑyla yaลayan bireyler iรงin รงok รถnemli bir dรถnรผm noktasฤฑ niteliฤindedir” dedi.
Gรผlmรผล, Parkinson hastalฤฑฤฤฑnda hastalฤฑฤฤฑn ilerlemesini yavaลlatabilecek veya durdurabilecek tedavilere yรถnelik yรผksek bir karลฤฑlanmamฤฑล ihtiyaรง bulunduฤunu belirterek, “SUL-238’in hastalฤฑฤฤฑn temelinde yer alan mitokondriyal fonksiyon bozukluฤunu hedefleyen etki mekanizmasฤฑnฤฑn, bu alanda dรถnรผลtรผrรผcรผ bir yaklaลฤฑm sunma potansiyeli taลฤฑdฤฑฤฤฑna inanฤฑyoruz” ifadesini kullandฤฑ.
GEN Genel Mรผdรผr Yardฤฑmcฤฑsฤฑ Dr. Nadir Ulu ise araลtฤฑrmanฤฑn baลlamasฤฑnฤฑn SUL-238 iรงin kritik รถneme sahip bir kavram kanฤฑtlama fฤฑrsatฤฑ sunduฤunu sรถyledi. “Araลtฤฑrmaya henรผz tedavi almamฤฑล hastalarฤฑn dahil edilmesi, SUL-238 ile erken dรถnemde yapฤฑlacak mรผdahalenin mitokondri fonksiyonunu iyileลtirip iyileลtiremeyeceฤini deฤerlendirmek aรงฤฑsฤฑndan benzersiz bir pencere aรงmaktadฤฑr” diye ekledi.
SUL-238 hakkฤฑnda
SUL-238, kฤฑล uykusu mekanizmalarฤฑndan ilham alฤฑnarak geliลtirilen ve mitokondriyi hedefleyen yenilikรงi bir kรผรงรผk molekรผl ilaรง adayฤฑ. Hรผcrenin enerji รผretim merkezini destekleyerek bozulmuล mitokondri fonksiyonlarฤฑnฤฑ iyileลtirmeyi hedefliyor. ฤฐlaรง adayฤฑ kan-beyin bariyerini geรงebiliyor ve hem klinik รถncesi hem de Faz I klinik araลtฤฑrmalarda gรผvenlilik profili araลtฤฑrฤฑlmฤฑล durumda.
| รzel Durum Aรงฤฑklamasฤฑ (Genel) | |
| Yapฤฑlan Aรงฤฑklama Gรผncelleme mi? | Evet (Yes) |
| Yapฤฑlan Aรงฤฑklama Dรผzeltme mi? | Hayฤฑr (No) |
| Konuya ฤฐliลkin Daha รnce Yapฤฑlan Aรงฤฑklamanฤฑn Tarihi | 16.03.2026 |
| Yapฤฑlan Aรงฤฑklama Ertelenmiล Bir Aรงฤฑklama mฤฑ? | Hayฤฑr (No) |
| Bildirim ฤฐรงeriฤi | |
| Aรงฤฑklamalar | |
Parkinson Hastalฤฑฤฤฑnฤฑn Tedavisinde Kฤฑล Uykusundan ฤฐlham Alan SUL-238'in Faz II Klinik Araลtฤฑrmasฤฑnda ฤฐlk Hastaya Tedavi Baลlandฤฑ. SHEPHERD kavram kanฤฑtlama klinik araลtฤฑrmasฤฑ, Parkinson hastalฤฑฤฤฑnda SUL-238'in mitokondriyal fonksiyon รผzerindeki etkilerini deฤerlendirecek. Ankara, Tรผrkiye, 8 Haziran 2026 โ GEN ฤฐlaรง ve Saฤlฤฑk รrรผnleri A.ล. (GENIL.IS), Parkinson hastalarฤฑnda mitokondriyal fonksiyon bozukluฤunu hedefleyen ilaรง adayฤฑ SUL-238'in Faz II kavram kanฤฑtlama klinik araลtฤฑrmasฤฑnda ilk hastaya tedavi baลlandฤฑฤฤฑnฤฑ duyurdu. SHEPHERD klinik araลtฤฑrmasฤฑ, erken evre ve tedavi almamฤฑล Parkinson hastalarฤฑnda SUL-238'in yรผksek enerjili fosfatlar รผzerindeki etkilerini manyetik rezonans spektroskopisi yรถntemiyle deฤerlendirecek. "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" baลlฤฑklฤฑ Faz II klinik araลtฤฑrmasฤฑnฤฑn detaylarฤฑna clinicaltrials.gov (NCT07322887) adresinden ulaลฤฑlabilir. GEN Yรถnetim Kurulu Baลkanฤฑ Abidin Gรผlmรผล, konuya iliลkin deฤerlendirmesinde ลunlarฤฑ sรถyledi: "SUL-238'in Faz II klinik araลtฤฑrmasฤฑnda ilk hastaya doz uygulanmasฤฑ, hem SUL-238 programฤฑ hem de Parkinson hastalฤฑฤฤฑyla yaลayan bireyler iรงin รงok รถnemli bir dรถnรผm noktasฤฑ niteliฤindedir. Parkinson hastalฤฑฤฤฑnda hastalฤฑฤฤฑn ilerlemesini yavaลlatabilecek veya durdurabilecek tedavilere yรถnelik yรผksek bir karลฤฑlanmamฤฑล ihtiyaรง bulunuyor. SUL-238'in hastalฤฑฤฤฑn temelinde yer alan mitokondriyal fonksiyon bozukluฤunu hedefleyen etki mekanizmasฤฑnฤฑn, bu alanda dรถnรผลtรผrรผcรผ bir yaklaลฤฑm sunma potansiyeli taลฤฑdฤฑฤฤฑna inanฤฑyoruz." GEN Genel Mรผdรผr Yardฤฑmcฤฑsฤฑ (Medikal, AR-GE ve Klinik Operasyonlar) Dr. Nadir Ulu ise ลunlarฤฑ ifade etti: "Bu araลtฤฑrmanฤฑn baลlamasฤฑ, SUL-238 iรงin kritik รถneme sahip bir kavram kanฤฑtlama fฤฑrsatฤฑ sunmaktadฤฑr. Araลtฤฑrmaya henรผz tedavi almamฤฑล hastalarฤฑn dahil edilmesi, SUL-238 ile erken dรถnemde yapฤฑlacak mรผdahalenin mitokondri fonksiyonunu iyileลtirip iyileลtiremeyeceฤini deฤerlendirmek aรงฤฑsฤฑndan benzersiz bir pencere aรงmaktadฤฑr. Bu araลtฤฑrmayฤฑ mรผmkรผn kฤฑlan tรผm hastalara, hasta yakฤฑnlarฤฑna ve araลtฤฑrmacฤฑlara teลekkรผr ediyoruz." Parkinson Hastalฤฑฤฤฑ Hakkฤฑnda Parkinson hastalฤฑฤฤฑ, 60 yaล รผzerindeki bireylerin %2'sine kadarฤฑnฤฑ etkileyen en yaygฤฑn nรถrodejeneratif hareket bozukluฤudur. ฤฐlerleyici seyir gรถsteren hastalฤฑkta, onlarca yฤฑldฤฑr sรผren araลtฤฑrmalara raฤmen mevcut tedaviler bรผyรผk รถlรงรผde semptomlarฤฑn yรถnetimine odaklanmakta; hastalฤฑฤฤฑn altta yatan ilerleyici doฤasฤฑnฤฑ deฤiลtiren tedavi seรงeneklerine yรถnelik ihtiyaรง halen devam etmektedir. Mitokondri fonksiyon bozukluฤunun ve oksidatif hasarฤฑn, Parkinson ve Alzheimer hastalฤฑklarฤฑ da dahil olmak รผzere nรถrodejeneratif hastalฤฑklarฤฑn patofizyolojisinde rol oynadฤฑฤฤฑ bilinmektedir. รok iลlevli organeller olan mitokondrilerin bรผtรผnlรผฤรผ, nรถronal fonksiyonlarฤฑn sรผrdรผrรผlmesi ve hรผcrelerin hayatta kalmasฤฑ aรงฤฑsฤฑndan kritik รถneme sahiptir. SUL-238 Hakkฤฑnda SUL-238, kฤฑล uykusu mekanizmalarฤฑndan ilham alฤฑnarak geliลtirilen ve mitokondriyi hedefleyen yenilikรงi bir kรผรงรผk molekรผl ilaรง adayฤฑdฤฑr. Hรผcrenin enerji รผretim merkezini destekleyerek bozulmuล mitokondri fonksiyonlarฤฑnฤฑ iyileลtirmeyi hedefler. SUL-238 nรถrodejeneratif, kardiyovaskรผler ve renal bozukluklar ile birlikte aynฤฑ zamanda yaลlanma modellerinde de umut verici etkiler gรถstermiลtir. Kan-beyin bariyerini geรงebilmektedir ve hem klinik รถncesi hem de Faz I klinik araลtฤฑrmalarda gรผvenlilik profili รงok detaylฤฑ ve titiz bir ลekilde araลtฤฑrฤฑlmฤฑลtฤฑr. GEN, 25 yฤฑlฤฑ aลkฤฑn tecrรผbesiyle Tรผrkiye'nin en hฤฑzlฤฑ bรผyรผyen ilaรง ลirketlerinden biridir. รok yรถnlรผ bir iล modeline sahip olan GEN, hem gรผรงlรผ kรผresel iล ortaklarฤฑ ile nadir hastalฤฑklar ve karลฤฑlanmamฤฑล saฤlฤฑk ihtiyaรงlarฤฑna dรผnya รงapฤฑnda รงรถzรผmler sunmakta hem de en iyi standartlarฤฑ karลฤฑlayan son teknoloji รผretim tesisi ve bรผyรผk Ar-Ge yatฤฑrฤฑmlarฤฑ ile uluslararasฤฑ pazarda yรผksek talep gรถren rekabetรงi รผrรผnler geliลtirmekte ve รผretmektedir. Sulfateq Hakkฤฑnda Sulfateq BV, yenilikรงi ilaรง geliลtirmeyi hฤฑzlandฤฑrmak iรงin akademik ve endรผstriyel araลtฤฑrma merkezleriyle stratejik iล birlikleri yรผrรผten, Hollanda merkezli bir biyoteknoloji ลirketidir. ลirket, mitokondri saฤlฤฑฤฤฑnฤฑ koruyan ve SUL bileลikleri adฤฑ verilen yenilikรงi kรผรงรผk molekรผl sฤฑnฤฑfฤฑ ajanlar geliลtirmektedir. 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, Tรผrkiye, June 08, 2026 โ GEN Pharmaceuticals (GENIL.IS), Tรผrkiye'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 Gรผlmรผล, 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 โ targeting mitochondrial dysfunction at the core of the disease โ 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-naรฏve 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 Tรผrkiye'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 | |
