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PL-3994 for Acute Severe Asthma

PL-3994, discovered and developed by scientists at Palatin Technologies, is a natriuretic peptide receptor A (NPRA) agonist compound.  PL-3994 has successfully completed both a Phase 1 and Phase 2a trial.

Acute exacerbations of asthma, also called acute severe asthma, is an ongoing asthma episode in which asthma symptoms do not adequately respond to initial bronchodilator or corticosteroid therapy. Inhaled beta-2 adrenergic receptor agonists, such as albuterol, and inhaled corticosteroids are primary treatments for asthma episodes. Some patients with acute exacerbations of asthma become unresponsive to beta-2 adrenergic receptor agonists, significantly limiting treatment options and increasing risk.

NPRA agonist compounds have demonstrated utility in relaxing smooth muscle in airways.  Published data supports this bronchodilator activity with both intravenous and aerosol NPRA agonist compounds.  Studies in human lung samples and guinea pig animal models have demonstrated that PL-3994 is a potent bronchodilator. Palatin Technologies is developing PL-3994 for treatment of acute severe asthma, particularly for use in patients not adequately treated by beta 2 agonists, such as albuterol rescue inhalers.  Acute severe asthma, particularly beta-2 agonist refractory asthma, is an area of high unmet medical need.

PL-3994 is a synthetic molecule, incorporating a novel and proprietary amino acid mimetic developed by Palatin Technologies.  PL-3994 has an extended half-life, with reduced affinity for natriuretic peptide clearance receptors and increased resistance to neutral endopeptidase, an endogenous enzyme that degrades natriuretic peptides. The result is a drug with improved pharmacokinetic and pharmacodynamic properties.

In 2006, the most recent year reported, there were almost 1.7 million emergency room visits due to asthma, with 440,000 hospitalizations attributed to asthma. In 2008, approximately 23.3 million Americans had asthma, with a projected 2010 economic cost in the United States of $20.7 billion, of which the largest single direct medical expenditure, $5.9 billion, is for prescription drugs.