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news.Auspex Pharmaceuticals has reported positive results from its Phase I clinical trial evaluating SD-254, a selective serotinin-norepinephrine reuptake inhibitor. Auspex is developing SD-254, a deuterium-substituted version of venlafaxine, for the treatment of major depressive disorder.
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In the clinical study conducted in 16 healthy volunteers, SD-254 exhibited a pharmacokinetic profile that appears to be superior to that of venlafaxine and consistent with that required for increasing safety and reducing side effects relative to existing therapies, while maintaining high patient response rates, said Auspex.
The company is planning additional studies to build on these observations and support an overall development plan for demonstrating safety and efficacy.
Thomas Gant, chief scientific officer of Auspex, said: “These results represent the first validation in humans of targeted deuterium substitution as a strategy for improving the pharmacokinetics and thus potentially the safety and performance of drugs. SD-254 has passed the first hurdle towards demonstrating the desired pharmaceutical profile, and we look forward to advancing its development.”