Palatin Technologies Inc, Cranbury, NJ, has received clearance from the US Food and Drug Administration (FDA) to begin a phase 2A 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 the treatment of acute exacerbations of asthma, particularly for use in patients not adequately treated by ß2 agonists, such as albuterol rescue inhalers.
Initially, PL-3994 was developed for the treatment of congestive heart failure. PL-3994 activates NPR-A, a receptor known to play a role in cardiovascular homeostasis. It increases plasma cyclic guanosine monophosphate (cGMP) levels, a pharmacological response consistent with the effect of endogenous (naturally produced) natriuretic peptides on cardiovascular function and smooth muscle relaxation.
Palatin is still seeking a development and marketing partner for PL-3994, which would include both the proof-of-concept phase 2A 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 third-party funding to support the proof-of-concept phase 2A human trial or preclinical inhalation toxicity studies.
Source: Palatin Technologies Inc.