* Says trial to assess physiologic responses to Surfaxin
* Says FDA indicated trial design acceptable
* Expects FDA comments on trial in Q1 2010
* Shares rise 3 pct pre-market
Nov 17 (Reuters) - Discovery Laboratories Inc DSCO.O said it submitted a proposed protocol to U.S. health regulators to conduct a limited clinical trial for its drug to treat respiratory illness in infants, Surfaxin.
The protocol submitted to the U.S. Food and Drug Administration incorporates a clinical trial design to assess the pharmacodynamic (PD) response — the physiologic responses to therapy — in preterm infants with respiratory distress syndrome after Surfaxin is administered.
The biotechnology company said the FDA indicated its proposed concept of a PD trial design was acceptable and also provided direction regarding certain trial design specifics.
It expects to receive the FDA’s comments early in the first quarter of 2010.
In April, the FDA declined to approve the marketing application for the drug. [ID:nBNG445146]
Shares of the company rose 3 percent to 91 cents Tuesday in pre-market trade. They closed at 88 cents Monday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Anne Pallivathuckal)