This week, the first dosings of SUL-238 in healthy volunteers in a Phase I study marks a major milestone in the clinical development of this hibernation-derived, first-in-class drug. The phase I study investigates the safety, tolerability and pharmacokinetics after single and repeated doses of SUL-238 in human as the first step towards patient benefit.


Development of SUL-238 originates from the exploration of protective mechanisms used during hibernation (‘winter sleep’). Further development of SUL-238 within Sulfateq has benefitted from various public-private andbusiness partnerships fueled by the innovative life science environment in Groningen with all disciplines for drug development present. SUL-238 was conceived in Groningen from the close collaboration between the research group of Prof. Dr. Rob Henning (UMCG) and Sulfateq, with help from Symeres (present name) and Ardena (present name). Subsequently, SUL-238 has been tested in the early preclinical stages by numerous academic departments including those of the University Medical Center Groningen (UMCG), Free University Amsterdam (VU) and Erasmus MC Rotterdam. The final stage of preclinical development of SUL-238 was accelerated by a research collaboration between Sulfateq and the Turkish pharmaceutical company GEN İlaç ve Sağlık Ürünleri Sanayi ve Ticaret A.Ş. (GEN), enabling the final pharmacokinetic and safety evaluation studies and clinical drug formulation.


About SUL-238
SUL-238 is a unique small molecule designed to target the ‘powerhouse’ of the cell, the mitochondria, and improve its function. This mechanism allows SUL-238 to restore proper mitochondrial function and mitigate progression of several and particularly chronic diseases in which mitochondrial dysfunction plays a major role. Positive preclinical proof of concept of the beneficial action of SUL-238 has been obtained in animal models for Alzheimer’s Disease (AD), Heart Failure (HF), Chronic Kidney Disease (CKD), Pulmonary Arterial Hypertension (PAH), Chronic Obstructive Pulmonary Disease (COPD), Acute Kidney Injury (AKI) and Sepsis. In addition, SUL-238 passed all safety tests required by drug regulatory authorities including the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).


More information
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