RCS - GEN Pharmaceuticals - GEN and Sulfateq BV Announce Positive Phase 1
28/07/2025 14:00
For best results when printing this announcement, please click on link below: https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250728:nRSb7793Sa&default-theme=true RNS Number : 7793S GEN Pharmaceuticals 28 July 2025 GEN and Sulfateq BV Announce Positive Phase 1 Trial Data on Investigational Drug SUL-238 for Alzheimer's and Other Neurodegenerative Diseases Phase 1 results demonstrate that SUL-238, a first-in-class, orally administered, mitochondria-directed drug candidate, is safe and well-tolerated in healthy elderly volunteers, showing a favourable pharmacokinetic profile and high brain penetration. These findings support the advancement of SUL-238 into further clinical development for Alzheimer's and other neurodegenerative diseases. ANKARA, TR / ACCESS Newswire (https://www.accessnewswire.com/) / July 28, 2025 / GEN Pharmaceuticals (GENIL.IS), Türkiye's leading specialty pharmaceutical company, announced positive results from its Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of first-in-class and novel orally administered mitochondria-directed drug candidate SUL-238 in healthy elderly volunteers. The findings were presented at the Alzheimer's Association International Conference 2025 (AAIC(®)) in Toronto. Click here for image (https://cdn.nwe.io/files/x/5b/fb/714bc98ab766e64c4901e387d565.jpg) . This single oral ascending dose (SAD) Phase 1, first-in-human, randomized, double-blind, placebo-controlled study was conducted in three parts, involving a total of 53 healthy elderly adults. Part 1 included 6 cohorts (50, 100, 250, 500, 1000, and 2000 mg orally, n=23). In Part 2, the PK of a single 1000 mg oral dose was investigated in 10 healthy elderly adults. In Part 2B, the food effect was assessed using a randomized, single oral 2000 mg dose, two-treatment, two-period, crossover design (n=20). The trial results showed that single oral doses of 50-2000 mg of SUL-238 were safe and well-tolerated, while demonstrating a favourable PK profile and high cerebrospinal fluid (CSF) penetration. These findings make SUL-238 a promising candidate for further clinical development in neurodegenerative diseases, including Alzheimer's disease. No adverse effects (AEs) limited dose escalation, AE rates were comparable between SUL-238 and placebo, and all AEs were mild or moderate. The mean terminal elimination half-life was 0.86-3.80 hours, and the time to maximum plasma concentration was 0.50-1.39 hours. Under fed conditions, maximum plasma concentration (C(max)) and area under the plasma concentration-time curve (AUC(0-∞)) decreased by 50% and 60%, respectively. CSF-to-plasma percentages at 2 and 8 hours post-dose were 21.1% (±6.6%) and 74.2% (±46.0%). Abidin Gülmüş, Chairman of GEN, stated: "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 novel, first-in-class, hibernation-derived small molecule that targets mitochondria, the cell's "powerhouse." It supports mitochondrial bioenergetics via complex I/IV activation and has improved mitochondrial function in rodent models of neurodegenerative, cardiovascular, and renal diseases, as well as aging. SUL-238 crosses the blood-brain barrier and has undergone extensive safety evaluation in preclinical and Phase 1 studies. GEN licenses SUL-238 from Sulfateq BV 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. GEN manufactures high-quality, competitive products at its GMP-certified facility and pursues original drug development through two dedicated R&D centers and investments. About Sulfateq: Sulfateq B.V. is an early-stage Dutch biotech company that fosters strategic collaborations with academic and industrial research centers to accelerate the development of innovative new medicines. It has developed a novel class of small molecules, the SUL-compounds, that maintain mitochondrial health. For more information: www.genilac.com.tr (https://www.genilac.com.tr) www.sulfateqbv.com (https://www.sulfateqbv.com) Contact Information Bulutay Güneş Sr. Head of Corporate Brand b.gunes@genilac.com Ali Ketencioğlu Investor Relations Manager a.ketencioglu@genilac.com Kees van der Graaf Sulfateq CEO info@sulfateqbv.com SOURCE: GEN İlaç ve Sağlık Ürünleri A.Ş. This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com (mailto:rns@lseg.com) or visit www.rns.com (http://www.rns.com/) . RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. 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