Under this agreement, Acologix is granted an exclusive license to develop and commercialize TRK-820 in North America. In Europe, Acologix and Toray will co-develop the compound and Acologix retains a commercialization option. The financial terms were not disclosed.
TRK-820 is a highly selective kappa opioid receptor agonist that has completed multiple phase II studies for the treatment of uremic pruritus, a severe itching condition in dialysis patients. As many as 50% of dialysis patients may suffer from uremic pruritus with approximately 20% developing severe and long-lasting effects.
A pivotal phase III study is planned to begin in Europe later this year. Acologix and Toray plan to submit a marketing authorization application in Europe following the completion of the planned pivotal study. In North America, Acologix will begin discussions with regulatory agencies to determine the appropriate development plan for product approval.