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ANKARA, Turkey, July 28, 2025 – (ACN Newswire) – GEN Prescribed capsules (GENIL.IS), Türkiye’s main strong level pharmaceutical firm, announced obvious results from its Allotment 1 scientific trial evaluating the security, tolerability, and pharmacokinetics (PK) of first-in-class and new orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were offered on the Alzheimer’s Affiliation World Convention 2025 (AAIC®) in Toronto.

This single oral ascending dose (SAD) Allotment 1, first-in-human, randomized, double-blind, placebo-controlled watch used to be performed in three parts, spirited a full of fifty three healthy elderly adults. Allotment 1 incorporated 6 cohorts (50, 100, 250, 500, 1000, and 2000 mg orally, n=23). In Allotment 2, the PK of a single 1000 mg oral dose used to be investigated in 10 healthy elderly adults. In Allotment 2B, the food conclude used to be assessed the expend of a randomized, single oral 2000 mg dose, two-treatment, two-duration, crossover assemble (n=20).

The trial results confirmed that single oral doses of 50-2000 mg of SUL-238 were stable and nicely-tolerated, while demonstrating a favourable PK profile and excessive cerebrospinal fluid (CSF) penetration. These findings originate SUL-238 a promising candidate for added scientific snort in neurodegenerative ailments, collectively with Alzheimer’s illness.

No side effects (AEs) restricted dose escalation, AE charges were comparable between SUL-238 and placebo, and all AEs were aloof or moderate. The mean terminal elimination half-lifestyles used to be 0.86-3.80 hours, and the time to maximum plasma focus used to be 0.50-1.39 hours. Below fed conditions, maximum plasma focus (Cmax) and space underneath the plasma focus-time curve (AUC0-∞) reduced by 50% and 60%, respectively. CSF-to-plasma percentages at 2 and eight hours put up-dose were 21.1% (±6.6%) and 74.2% (±46.0%).

Abidin Gülmüs, Chairman of GEN, said:”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, PhD, Vice President of R&D at GEN, added:”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 a new, first-in-class, hibernation-derived itsy-bitsy molecule that targets mitochondria, the cell’s “powerhouse.” It supports mitochondrial bioenergetics via complex I/IV activation and has improved mitochondrial feature in rodent objects of neurodegenerative, cardiovascular, and renal ailments, as well to aging. SUL-238 crosses the blood-brain barrier and has undergone broad security review in preclinical and Allotment 1 reports. GEN licenses SUL-238 from Sulfateq BV for neurodegenerative illness applications.

About GEN:

Founded in 1998, GEN is Türkiye’s main strong level pharmaceutical firm, centered on developing innovative therapies across a couple of therapeutic areas. GEN manufactures excessive-quality, competitive merchandise at its GMP-certified facility and pursues usual drug snort via two dedicated R&D centers and investments.

About Sulfateq:

Sulfateq B.V. is an early-stage Dutch biotech firm that fosters strategic collaborations with academic and industrial analysis centers to tempo up the enchancment of innovative unusual medicines. It has developed a new class of itsy-bitsy molecules, the SUL-compounds, that shield mitochondrial health.

For extra recordsdata:
www.genilac.com.tr
www.sulfateqbv.com

Contact Files
Bulutay Günes
Sr. Head of Company Ticket
b.gunes@genilac.com

Ali Ketencioglu
Investor Relatives Supervisor
a.ketencioglu@genilac.com

Kees van der Graaf
Sulfateq CEO
recordsdata@sulfateqbv.com

Topic: Press originate summary

Source: GEN Prescribed capsules

Sectors: Healthcare & Pharm

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