Suven Life Sciences today said it has completed trials on animals of its 'SUVN-502' molecule, which is to be developed for treatment of central nervous system disorders like Alzheimer\'s disease and schizophrenia.
"SUVN-502 has completed all long-term chronic studies like 6-month rat tox, 9-month dog tox and development tox studies... Very successfully and demonstrated a very high margin of safety," Suven said in a filing to the Bombay Stock Exchange (BSE).
The regulatory toxicological studies are essential for Food and Drug Administration (FDA) approval to initiate the second phase of human trials in the patient population, the company added.
Earlier, the company had tested the new molecule for human phase-I trials in Switzerland.
"The potential market opportunity is more than $20 billion globally," Suven Life Sciences CEO Venkat Jasti said.
The next phase will involve Phase 2a clinical trials on patients with Alzheimer's and Schizophrenia, the company said.
"We are actively engaged to file an investigational new drug application (IND) with the USFDA to support initiation of phase 2a proof of concept clinical trials in human patients during this year using this tox data," it added.
Shares of Suven Life Sciences were being quoted at Rs 21.20 apiece on the BSE in late afternoon trade today, up 4.95 per cent from their previous close.