Palatin Technologies, Inc. announced that the US Food and Drug Administration (FDA) has cleared Palatin's request to begin a phase II A proof-of-concept human trial under an Investigational New Drug (IND) application using a subcutaneously administered formulation of PL-3994, an NPR-A agonist compound, in development for treatment of acute exacerbations of asthma.

“We are excited about the prospect of advancing PL-3994 into a phase II A human trial to treat asthma patients,” stated Dr Carl Spana, Palatin’s chief executive officer. “Existing therapies for acute exacerbations of asthma in patients unresponsive to beta-2 adrenergic receptor agonists have limitations, including typically taking several hours for significant patient improvement. PL-3994, which works through a different pathway than beta-2 adrenergic receptor agonists and other approved bronchodilators, is intended to address this unmet medical need.”

Palatin is seeking a development and marketing partner for PL-3994, which would include both the proof-of-concept phase II A human trial for asthma and development of an inhalation formulation. Palatin does not intend to initiate either the proof-of-concept human trial or preclinical inhalation toxicity studies unless and until an agreement is reached with a development and marketing partner or Palatin receives funding to support the proof-of-concept phase II A human trial or preclinical inhalation toxicity studies from a third party, such as grant funding from an agency of the federal government.

PL-3994 is an NPR-A agonist compound in development for treatment of acute exacerbations of asthma, heart failure and refractory hypertension. PL-3994 activates NPR-A, a receptor known to play a role in cardiovascular homeostasis.

PL-3994 increases plasma cyclic Guanosine Mono-Phosphate (cGMP) levels, a pharmacological response consistent with the effects of endogenous (naturally produced) natriuretic peptides on cardiovascular function and smooth muscle relaxation.

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.

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.

Palatin Technologies, Inc. is a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonists with a focus on melanocortin and natriuretic peptide receptor systems and strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.