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Phase 1 results show that SUL-238 is safe, well-tolerated, and demonstrates favorable pharmacokinetics with high CSF penetration in healthy elderly volunteers, supporting its advancement into further clinical development for Alzheimer’s and other neurodegenerative diseases.<\/strong><\/i><\/p>\n<\/p><\/div>\n SUL-238 was originally discovered by Sulfateq and has since been further developed through a collaborative effort of Sulfateq and GEN as a novel therapeutic in neurodegenerative diseases.<\/p>\n This Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics (PK) after multiple-ascending doses (MAD) of orally administered SUL-238 in healthy elderly men and women (aged \u226540 years).<\/strong> The study included two cohorts with a treatment period of 14 days and a safety follow-up through 14 days after the last dose. 15 healthy adults in each cohort were randomized in a 2:1 ratio to receive SUL-238 or placebo. Total daily dose of SUL-238 was 4000 mg (2000 mg b.i.d., first cohort) or 4500 mg (1500 mg t.i.d., second cohort). SUL-238 demonstrated an excellent safety and tolerability profile after multiple doses in both cohorts, while demonstrating a favourable PK profile and a high cerebrospinal fluid (CSF) penetration<\/strong>, making it a promising candidate for further clinical development in neurodegenerative diseases, including Alzheimer’s and Parkinson’s diseases.<\/p>\n Key Findings:<\/strong><\/p>\n Safety in both cohorts:<\/p>\n No clinically significant changes were observed in physical and neurological exams, vital signs, ECG, and clinical laboratory parameters.<\/p>\n<\/li>\n AE rates were comparable between participants receiving SUL-238 and placebo.<\/p>\n<\/li>\n All AEs were of mild intensity or considered not related to SUL-238.<\/p>\n<\/li>\n<\/ul>\n First cohort PK (2000 mg b.i.d.):<\/p>\n SUL-238 was rapidly absorbed with a mean time to maximum plasma concentration (Tmax<\/sub>) reached at 1.25(\u00b10.54) and 1.50(\u00b10.53) hours on day 1 and day 14, respectively.<\/p>\n<\/li>\n Mean terminal elimination half-life (t1\/2<\/sub>) was3.50(\u00b11.06) hours on day 14.<\/p>\n<\/li>\n Mean trough plasma concentration of SUL-238 was 39.23(\u00b124.31) ng\/mL and 41.49(\u00b118.20) ng\/mL on day 8 and day 14, respectively.<\/p>\n<\/li>\n<\/ul>\n Second cohort PK (1500 mg t.i.d.):<\/p>\n SUL-238 was rapidly absorbed, with a mean time to maximum plasma concentration (Tmax<\/sub>) reached at 0.95(\u00b10.16) and 1.00(\u00b10.00) hours on day 1 and day 14, respectively.<\/p>\n<\/li>\n Mean terminal elimination half-life (t1\/2<\/sub>):3.74(\u00b11.84) hours on day 14.<\/p>\n<\/li>\n Mean trough plasma concentration of SUL-238 was 57.98(\u00b131.08) and 60.63(\u00b164.14) ng\/mL on day 8 and day 14, respectively.<\/p>\n<\/li>\n<\/ul>\n Abidin G\u00fclm\u00fc\u015f<\/strong>, Chairman of GEN, stated: Nadir Ulu, MD, PhD<\/strong>, Vice President of R&D at GEN, added: About SUL-238<\/strong> About GEN:<\/strong> About Sulfateq:<\/strong><\/p>\n Sulfateq B.V. is an early-stage Dutch biotech company 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 molecules, the SUL-compounds, that maintain mitochondrial health.<\/p>\n For more information:<\/strong> Contact Information<\/strong><\/p>\n Bulutay G\u00fcne\u015f Fatih G\u00f6ren <\/p>\n Source: GEN \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri A.\u015e.<\/p>\n<\/p><\/div>\n
\n ANKARA, Turkey, December 2, 2025 (Newswire.com)
\n –
\n <\/strong>GEN Pharmaceuticals (GENIL.IS), T\u00fcrkiye’s leading specialty pharmaceutical company, has announced new positive results from its Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of first-in-class, novel orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were presented at the 18th<\/sup> Clinical Trials on Alzheimer’s Disease (CTAD)<\/strong> in San Diego, CA (United States) today.<\/p>\n\n
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“We’re greatly motivated by these new positive results of SUL-238 in our Phase 1 trial, which mark a key advance toward addressing Alzheimer’s disease at its biological foundation.”<\/i><\/p>\n
“With its excellent safety and PK profile in this Multiple Ascending Dose Phase 1 trial, SUL-238 continues to represent a very strong drug candidate for further clinical development aimed at meeting the critical unmet needs in neurodegenerative diseases, including Alzheimer’s disease.<\/i><\/p>\n
SUL-238 is a novel, first-in-class, hibernation-derived 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 models for neurodegenerative, cardiovascular, and renal diseases, as well as in accelerated aging. SUL-238 exhibits the capability to cross the blood-brain barrier and has undergone extensive safety evaluation in preclinical and clinical Phase 1 studies. GEN licenses SUL-238 from Sulfateq B.V. for neurodegenerative disease applications.<\/p>\n
Founded in 1998, GEN is T\u00fcrkiye’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.<\/p>\n
www.genilac.com.tr<\/a>
www.sulfateqbv.com<\/a><\/p>\n
Sr. Head of Corporate Brand<\/i>
b.gunes@genilac.com<\/a><\/p>\n
Investor Relations Manager<\/i>
f.goren@genilac.com<\/a><\/p>\n