Background

Developed by Suven Inc., the Delawa-based subsidiary of Indian company Suven Life Sciences, SUVN-502 is a selective antagonist of the 5-HT6 serotonin receptor. This G protein-coupled receptor is expressed mostly in the brain, where it mediates neurotransmission for functions including cognition and memory. Blocking this receptor increases cholinergic and glutamatergic signaling, and other 5-HT6 receptor antagonists have been reported to improve cognition or are being developed as treatments for Alzheimer's, as well (see Upton et al., 2008; RVT-101; Idalopirdine; Dimebon; see Bezprozvanny 2010).

No information about this compound is published in the peer-reviewed literature. Suven scientists reported some preclinical data for it, claiming that it readily enters the brain, increased brain acetylcholine and glutamate levels, and reversed memory deficits in adult rats (Nirogi et al., 2011).

Findings

According to the company's website, Phase 1 studies were conducted in Switzerland in 2008. At the 2009 ICAD conference, Suven scientists presented positive safety and pharmacokinetic data from a single ascending-dose Phase 1 trial conducted in healthy men (Nirogi et al., 2009). 

In September 2015, a Phase 2a proof-of-concept trial began enrolling what is to be 537 patients with probable Alzheimer's disease as diagnosed by the 1984 NINCDS-ADRDA criteria and a MMSE of between 12 and 20. The trial will compare 26 weeks of treatment with a high and a low dose of SUVN-502 to placebo, all given in addition to donepezil. Conducted at 57 sites in the United States, this trial will measure change on the ADAS-cog as primary outcome, and change on the CDR and various clinical and functional scales as secondary outcomes. It is set to run through spring 2017. 

For trials of this compound, see clinicaltrials.gov.

Clinical Trial Timeline