Discovery Labs' Surfaxin Phase 2 BPD Clinical Trial Results Published in Pediatrics
Discovery Labs' Surfaxin(r) Phase 2 BPD Clinical Trial Results Published in Pediatrics
WARRINGTON, Pa., Jan. 5, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces the publication of results from its Phase 2 clinical trial of Surfaxin(r) for the prevention and treatment of Bronchopulmonary Dysplasia (BPD) in Pediatrics, a premier medical journal for pediatric critical-care healthcare practitioners. BPD is a chronic, debilitating lung disease typically affecting premature infants who received treatment for Respiratory Distress Syndrome (RDS). The results from the study indicated that administration of additional doses of Surfaxin following standard SRT treatment for acute RDS may represent a novel therapeutic option for infants at risk for developing BPD. Presently, there are no approved pharmaceutical therapies for BPD.
These results appear in the following manuscript published in the January issue of Pediatrics:
* A Pilot Randomized, Controlled Trial of Later Treatment with a Peptide-Containing, Synthetic Surfactant for the Prevention of Bronchopulmonary Dysplasia (Laughon et al. Pediatrics 2009;123 89-96)
Robert J. Capetola, President and CEO of Discovery Labs commented, "We are extremely pleased that Pediatrics has published these data and made them available to the medical community. We believe that these data further validate the pharmacology of our KL-4 surfactant and support our continued development of our technology platform to address a broad range of unmet medical needs in pulmonary medicine."
Discovery Labs conducted a Phase 2 clinical trial to evaluate the safety and potential efficacy of Surfaxin in infants at risk for BPD. The clinical trial enrolled 136 premature infants that were randomized to receive, in addition to standard of care, either Surfaxin standard dose (175 mg/kg), Surfaxin low dose (90 mg/kg), or sham air as a control. In this pilot estimation study, infants treated with the Surfaxin standard dose, as compared to those in the control group experienced a lower incidence of death or BPD (58% vs. 66%), a higher survival rate through 36 weeks post-menstrual age (89% vs. 84%), and fewer days on mechanical ventilation. No meaningful conclusions could be drawn from the Surfaxin low dose treatment group, likely due to this group containing infants with more pre-existing medical risk conditions.
Dr. Matthew Laughon, Assistant Professor, Department of Pediatrics, Division of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, commented, "The data from this Phase 2 estimation trial support additional trials to evaluate the potential of Surfaxin as a therapeutic option for the prevention of BPD. BPD represents one of the most challenging clinical problems we face in neonatology. Extremely low birth weight infants, particularly those that require mechanical ventilation, are at risk for this debilitating disorder."
BPD is associated with surfactant deficiency and is diagnosed when premature infants require mechanical ventilation or supplemental oxygen at 36 weeks post-menstrual age. Premature infants are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen to survive, resulting in RDS. These infants often require endotracheal intubation to administer one of the currently-available, animal-derived surfactants (usually within the first hours of birth) and to provide respiratory support via mechanical ventilation. Unfortunately, many infants relapse following initial SRT and require reintubation and prolonged mechanical ventilation as well as supplemental oxygen, which increases the risk of developing BPD. Discovery Labs believes that BPD may be prevented with repeated doses of Surfaxin administered after the initial RDS SRT treatment (on day 1 or 2 of life) to improve the clinical outcome of these infants.
SURFAXIN(r), an investigational drug, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. The publication listed above includes information that may be of interest to healthcare practitioners; however, the clinical relevance of this information has not been established.
About the medical journal, Pediatrics
Pediatrics, the official journal of the American Academy of Pediatrics, publishes papers on original research or observations and special feature articles in the field of pediatrics. The Executive Board and Officers of the American Academy of Pediatrics select articles that appear in Pediatrics. The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists dedicated to the health, safety, and well-being of infants, children, adolescents, and young adults. The Academy is committed to the attainment of optimal physical, mental, and social health for all infants, children, adolescents and young adults.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs' lead product from its SRT pipeline is SURFAXIN(r) for the prevention of Respiratory Distress Syndrome in premature infants. The U.S. Food and Drug Administration (FDA) has established April 17, 2009 as its target date to complete its review of this new drug application (NDA) and potentially grant marketing approval for this product. SURFAXIN is also being developed for other neonatal and pediatric indications. AEROSURF(r), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made, including, without limitation, the risks that: Discovery Labs' response to the May 2008 Approvable Letter for Surfaxin may not satisfy the FDA; the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that Discovery Labs may file for its products, or may not approve any such applications or may limit marketing of such products to particular indications or impose unanticipated label limitations; changes in the national or international political and regulatory environment may make it more difficult for Discovery Labs to gain FDA or other regulatory approval of its products; Discovery Labs may be unable to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT), which could cause Discovery Labs to cut back or suspend its development activities or potentially cease operations; Discovery Labs' lengthy and costly research and development programs, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products, may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs or its contract manufacturers or materials suppliers may be unable to successfully manufacture adequate supplies of its drug product or drug substances when needed or in amounts sufficient to meet demand; Discovery Labs may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT technology; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further described in Discovery Labs filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
Company Contact: Lisa Caperelli, Investor Relations 215-488-9413
Posted: January 2009