* To conduct preclinical studies instead of clinical trial
* Expects to file complete response in Q1 2011
* Shares up 10 pct premarket
Feb 16 (Reuters) - Drug developer Discovery Laboratories Inc DSCO.O said it will conduct additional preclinical studies, instead of a limited clinical trial, to gain approval for its drug to treat respiratory illness in infants, sending its shares up 10 percent before the bell.
In November, the company submitted a proposed protocol to U.S. health regulators to conduct a limited clinical trial to assess the pharmacodynamic (PD) response — the physiologic responses to therapy — in preterm infants with respiratory distress syndrome (RDS) to the drug Surfaxin. [ID:nBNG418855]
“Compared to the conduct of a PD clinical trial, a comprehensive preclinical program, if successful, presents an opportunity to significantly reduce the time and expense required to gain potential Surfaxin approval,” the company said.
The recently received guidance from the U.S. Food and Drug Administration advises that an acceptable and already existing animal model of RDS could be used as an acceptable alternative to a clinical trial in human preterm infant, the company said.
The company expects to submit a complete response to the FDA in the first quarter of 2011.
Shares of the company were up 7 cents at 76 cents in premarket trade. They closed at 69 cents Friday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Aradhana Aravindan)