MOUNTAIN VIEW, Calif., Feb. 27 /PRNewswire/ -- MAP Pharmaceuticals, Inc. announced today that its Unit Dose Budesonide (UDB) drug candidate met its primary efficacy endpoints in a Phase 2 clinical trial. UDB is a proprietary nebulized formulation of budesonide for treatment of pediatric asthma.
The multicenter, randomized, double-blind, placebo-controlled U.S. based study aimed to assess the efficacy of UDB versus placebo at two doses in patients as young as 12-months old. The study met its primary efficacy endpoints. The high dose evaluated in the study was equivalent to the lowest dose available of the currently marketed nebulized budesonide product.
The primary endpoints for the study were asthma control as assessed by changes in morning asthma symptom scores compared to placebo, and trends in Forced Expiratory Volume in one second (FEV1). No serious adverse events were reported in the study, and UDB was shown to be well tolerated. In addition, there were no statistically significant changes in cortisol levels as compared to placebo over the duration of the study. While not a head-to-head study, the mean nebulization time for UDB using the same nebulizer was shown to be substantially less than the published nebulization time of the currently marketed nebulizer product.
The company plans to present the results from this study at a future scientific conference.
“This study shows the potential clinical benefits of our proprietary candidate,” said Stephen B. Shrewsbury MD, Vice President of Clinical and Regulatory Affairs at MAP Pharmaceuticals. “We wish to thank the clinical investigators for their support, which was critical to the successful execution of this Phase 2 study. We look forward to moving into Phase 3 clinical development following our scheduled End of Phase 2 meeting with the FDA.”
“The results of this Phase 2 study support our efforts to develop the lowest dose nebulized maintenance therapy for treatment of young children with asthma,” said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. “Our goal is to provide patients with a faster, more convenient therapy with improved compliance at a lower dose that retains the proven efficacy of budesonide. We aim to improve the lives of young children suffering from asthma.”
About Unit Dose Budesonide
MAP Pharmaceuticals is developing a novel submicron formulation of nebulized budesonide. Budesonide is a drug that has been used for more than 20 years with demonstrated safety and efficacy. Unit Dose Budesonide is initially being developed as a first-line therapy for the maintenance treatment and prophylactic therapy for pediatric asthma. However, due to its versatility, it may have applicability in other large, underserved diseases such as chronic obstructive pulmonary disease (COPD). The product is intended to provide efficacy at a lower overall corticosteroid dose than currently commercially available products. In addition, significantly faster administration times could allow for better compliance and assurance of appropriate dosage delivery.
About Pediatric Asthma
Of the estimated 20 million diagnosed asthma patients in the United States, there are about six million children under 18 years of age and over one million children under five years of age with asthma. Typically in the U.S., very young children, usually below the age of five, use a nebulizer to take their inhaled corticosteroid medication because they lack the breath coordination needed to use pressurized metered-dose inhalers or they lack the lung capacity needed to use dry powder inhalers. Children with mild asthma and infrequent attacks typically use medication infrequently or as needed, while children with persistent and severe asthma take medication on a regular basis to prevent serious exacerbations. With proper treatment, most children with asthma can lead a normal life. Sales of nebulized corticosteroids are expected to approach $1 billion within the next few years.
About MAP Pharmaceuticals, Inc.
Located in Mountain View, California, MAP Pharmaceuticals, Inc. is a privately-held, biopharmaceutical company focused on developing novel treatments for respiratory and CNS diseases. The Company has recently completed studies as part of two Phase 2 clinical development programs involving a proprietary formulation of nebulized budesonide for the potential treatment of children with asthma, and a proprietary formulation of an inhaled ergot alkaloid delivered by the Company’s proprietary Tempo(TM) Inhaler, for the potential treatment of migraines. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com .
MAP Pharmaceuticals, Inc.
CONTACT: media, Lisa Johnson of MAP Pharmaceuticals, Inc.,+1-650-386-3122, or ljohnson@mappharma.com
Web site: http://www.mappharma.com//
