SUVN-502 is being developed by Suven Life Sciences for the treatment of Alzheimer’s disease.

How SUVN-502 works

SUVN-502 blocks the serotonin receptor 5-HT6, a protein responsible for binding the neurotransmitter (or signaling molecule) serotonin, one of the key chemicals regulating the activity of brain cells. 5-HT6 is found exclusively in the central nervous system (the brain and the spinal cord). It is known to dominate the brain regions that are associated with cognition (thinking ability) and behavior.

Upon administration, SUVN-502 blocks 5-HT6, preventing it from binding to serotonin. The blockage has been found to improve cognitive performance in animals.

SUVN-502 in clinical trials

Preclinical data from a study conducted in animal models, presented in a poster by the company, revealed that SUVN-502 was successful in penetrating the central nervous system and was effective in reversing memory deficits in adult rats. SUVN-502 was also found to reverse memory deficits associated with aging.

Based on these promising results, the safety and tolerability of SUVN-502 were investigated in healthy young adults and elderly patients in a Phase 1 clinical trial. In the study, participants received increasing oral doses of SUVN-502. The results, published in the scientific journal Clinical Drug Investigation, showed that SUVN-502 was safe and well-tolerated in both young adults and elderly patients.

The treatment is now being investigated for its safety and effectiveness in patients with moderate Alzheimer’s disease in a Phase 2 clinical trial (NCT02580305). The double-blind, multicenter, randomized, placebo-controlled trial has recruited 563 participants from 70 locations across the U.S.

The primary goal of this study is to measure cognitive changes in the participants, using the Alzheimer’s disease assessment scale-cognitive subscale score. Secondary endpoints include changes in behavioral disturbance and cognitive aspects of mental function in patients. Recruitment has finished and the study is estimated to be completed in October of 2019.

Suven has also opened an Expanded Access Program (NCT03564964) to allow patients who have completed the Phase 2 trial to continue to have access to SUVN-502.

 

Last updated: Sept. 2, 2019

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