Biotechnology company Discovery Laboratories Inc. (DSCO), Tuesday said it submitted a proposed protocol with FDA, for a limited clinical trial evaluating its respiratory illness drug in pre-term infants. Currently, Discovery stock is trading down 7% on the Nasdaq.
According to the company, the protocol incorporates a clinical trial design, primarily intended to assess a pharmacodynamic or PD response following Surfaxin administration in infants with Respiratory Distress Syndrome or RDS. The disease causes breathing problems in infants whose lungs have not yet fully developed. The company said a comment from FDA lead to the trial design. The final protocol, however, is subject to FDA review and comment, which the company anticipates in the first quarter next year.
The Warrington, Pennsylvania- based company has received an orphan drug status for Surfaxin in 2004. In April this year, FDA issued a complete response letter with primary focus on certain aspects of a Surfaxin biological activity test for quality control stability and release of the drug.
At an end-of-review meeting with the FDA on June 2009, the FDA suggested a limited clinical trial to increase the likelihood of gaining Surfaxin approved, and also provided guidance for the same.
Later in September, the company consulted and got acceptance for its proposed concept of a PD trial design, one which primarily assess short-term, physiologic responses to therapy and, therefore, are generally less expensive and of shorter duration than trials that have clinical outcomes as a primary endpoint.
With the PD trial close to materializing, the company has taken yet another step to make its Surfaxin sale in the U.S. RDS market represents 1% of all new born babies, and the disease is a leading cause of death in preterm infants.
DSCO is currently trading at $0.813, losing $0.067 cents or 7.6%, on 1.99 million shares on the Nasdaq.
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