Suven Life Sciences Ltd said that its clinical drug candidate SUVN-502 completed all the long term chronic studies like 6-month rat tox, nine month dog tox and developmental tox studies like prenatal development tox in rats and rabbits, embryo-fetal development tox in rats and male fertility tox in rats very successfully and demonstrated very high margin of safety (MOS).  

The company said that these regulatory tox studies are essential for the Food Drug Administration (FDA) approval to initiate human phase 2a clinical trials in patient population. It added that SUVN-502 has been tested in human phase 1 trials in Switzerland and demonstrated to be very safe at all doses and durations tested with excellent bioavailability. The next stage of testing will be proof of concept phase 2 a clinical trials in patients with Alzheimer’s or schizophrenia disease.

"We are very pleased with the excellent outcome of all chronic and developmental tox studies for our clinical candidate SUVN-502 which is being developed for CNS disorders like Alzheimer’s disease, Attention Deficient Hyperactivity Disorder (ADHD), Huntington’s disease, Parkinson and schizophrenia and the potential market opportunity is more than $20 billion globally”, said Venkat Jasti, CEO, Suven Life Sciences.

The company further said that it has received several interests for SUVN-502 from pharmaceutical companies and is likely to enter partnership in the near future. It is also actively engaged to file an Investigational New Drug application (IND) with the US FDA to support initiation of phase 2 a Proof of Concept (PoC) clinical trials in human patients during this year using this tox data.