ANKARA, Turkey, July 28, 2025 – (ACN Newswire) –GEN Pharmaceuticals (GENIL.IS), Türkiye’s leading specialized pharmaceutical business, revealed favorable arise from its Phase 1 medical trial assessing the security, tolerability, and pharmacokinetics (PK) of first-in-class and unique orally administered mitochondria-directed drug prospect SUL-238 in healthy senior volunteers. The findings existed at the Alzheimer’s Association International Conference 2025 (AAIC ®) in Toronto.
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This single oral rising dosage(SAD)Phase 1, first-in-human, randomized, double-blind, placebo-controlled research study was carried out in 3 parts, including an overall of 53 healthy senior grownups. Part 1 consisted of 6 associates (50, 100, 250, 500, 1000, and 2000 mg orally, n=23). In Part 2, the PK of a single 1000 mg oral dosage was examined in 10 healthy senior grownups. In Part 2B, the food result was examined utilizing a randomized, single oral 2000 mg dosage, two-treatment, two-period, crossover style (n=20).
The trial results revealed that single oral dosages of 50-2000 mg of SUL-238 were safe and well-tolerated, while showing a beneficial PK profile and high cerebrospinal fluid (CSF) penetration. These findings make SUL-238 an appealing prospect for additional medical advancement in neurodegenerative illness, consisting of Alzheimer’s illness.
No negative impacts (AEs) minimal dosage escalation, AE rates were equivalent in between SUL-238 and placebo, and all AEs were moderate or moderate. The mean terminal removal half-life was 0.86-3.80 hours, and the time to optimum plasma concentration was 0.50-1.39 hours. Under fed conditions, optimum plasma concentration (Cmax) and location under the plasma concentration-time curve (AUC0-∞) reduced by 50% and 60%, respectively. CSF-to-plasma portions at 2 and 8 hours post-dose were 21.1% ( ± 6.6%) and 74.2% ( ± 46.0%).
Abidin GülmüsChairman of GEN, mentioned:”We are very encouraged by these promising first-in-human results, marking an important step forward in our mission to address the underlying biology of Alzheimer’s disease.”
Nadir Ulu, MD, PhDVice President of R&D at GEN, included:”With its excellent safety and PK profile in this Phase 1 trial, combined with robust preclinical data, SUL-238 represents a strong candidate for further clinical development to meet the critical unmet needs in neurodegenerative diseases, including Alzheimer’s disease.”
About SUL-238
SUL-238 is an unique, first-in-class, hibernation-derived little particle that targets mitochondria, the cell’s “powerhouse.” It supports mitochondrial bioenergetics by means of complex I/IV activation and has actually enhanced mitochondrial function in rodent designs of neurodegenerative, cardiovascular, and kidney illness, along with aging. SUL-238 crosses the blood-brain barrier and has actually gone through substantial security examination in preclinical and Phase 1 research studies. GEN licenses SUL-238 from Sulfateq BV for neurodegenerative illness applications.
About GEN:
Established in 1998, GEN is Türkiye’s leading specialized pharmaceutical business, concentrated on establishing ingenious treatments throughout several restorative locations. GEN produces premium, competitive items at its GMP-certified center and pursues initial drug advancement through 2 devoted R&D centers and financial investments.
About Sulfateq:
Sulfateq B.V. is an early-stage Dutch biotech business that cultivates tactical cooperations with scholastic and commercial proving ground to speed up the advancement of ingenious brand-new medications. It has actually established an unique class of little particles, the SUL-compounds, that preserve mitochondrial health.
To learn more:
www.genilac.com.tr
www.sulfateqbv.com
Contact Information
Bulutay Günes
Sr. Head of Corporate Brand
b.gunes@genilac.com
Ali Ketencioglu
Financier Relations Manager
a.ketencioglu@genilac.com
Kees van der Graaf
Sulfateq CEO
info@sulfateqbv.com
Subject: Press release summary
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