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ANKARA - GEN Pharmaceuticals (GENIL.IS), a Turkish specialty pharmaceutical company, announced Monday that its investigational drug candidate SUL-238 demonstrated positive results in a Phase 1 clinical trial for Alzheimer’s and other neurodegenerative diseases.
The first-in-human trial evaluated the safety, tolerability, and pharmacokinetics of the orally administered mitochondria-directed drug in 53 healthy elderly volunteers across three study parts.
According to the company’s press release, single oral doses ranging from 50-2000 mg were found to be safe and well-tolerated, with adverse event rates comparable between SUL-238 and placebo. All reported adverse events were mild or moderate, with none limiting dose escalation.
The drug demonstrated a favorable pharmacokinetic profile with a mean terminal elimination half-life of 0.86-3.80 hours. The company reported that SUL-238 showed high brain penetration, with cerebrospinal fluid-to-plasma percentages at 2 and 8 hours post-dose of 21.1% and 74.2%, respectively.
Under fed conditions, the maximum plasma concentration and area under the plasma concentration-time curve decreased by 50% and 60%, respectively.
SUL-238 is described as a hibernation-derived small molecule that targets mitochondria, supporting cellular energy production through complex I/IV activation. The drug has shown improved mitochondrial function in rodent models of various diseases, including neurodegenerative conditions.
GEN Pharmaceuticals licenses SUL-238 from Dutch biotech company Sulfateq BV for neurodegenerative disease applications.
The findings were presented at the Alzheimer’s Association International Conference 2025 in Toronto.
Based on these results, the company plans to advance SUL-238 into further clinical development for Alzheimer’s and other neurodegenerative diseases.
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