The award funds continued development of PL 4500, a molecular complex of indomethacin and phosphatidylcholine that is being developed as a gastrointestinal (GI) safer anti-inflammatory and analgesic in both oral and IV formulations.
The Phase II award follows the successful completion of a Phase I program, in which PL 4500 was shown in in vivo and in vitro models to provide a longer period of analgesia with less GI toxicity than traditional indomethacin at standard doses while providing an equivalent degree of anti-inflammatory and analgesic efficacy, the company said. Such a GI-safer formulation of indomethacin could be used for the treatment of inflammation and pain due to trauma or surgery, while avoiding the sedative and addictive potential of opioid pain medications, according to the company.
During the Phase II period, PLx said that it will employ a multi-institutional collaboration with the University of Texas Health Science Center – Houston and the University of Texas Medical Branch – Galveston to capitalize on unique and established animal models to expand on PL 4500’s potential to safely treat inflammation and pain due to surgery or trauma, and to carry out formulation optimization and manufacturing process-development activities to support commercial development.