Hapten Sciences, Inc., a privately held biotechnology company, announced today that it has filed an Investigational New Drug (IND) application and is now planning to initiate dosing of healthy volunteers in a first-in-human Phase 1 clinical trial of its lead product candidate, PDC-APB, a novel, first-in-class, compound in development for a new indication to prevent contact dermatitis due to exposure to poison ivy, oak, and sumac. Hapten Sciences obtained a world-wide, exclusive license for the technology from the University of Mississippi.
The initial trial is a randomized, double-blind, placebo-controlled study of single ascending doses and is intended to determine the safety and tolerability of PDC-APB. In addition, Hapten Sciences is planning a multiple ascending dose study in individuals that are sensitive to poison ivy. These studies are intended to be conducted during 2016.
"Since company inception, Hapten Sciences has pursued an aggressive and efficient development timeline. We are enthusiastic that we are able to begin clinical development of a first-in-class compound that can potentially prevent contact dermatitis, associated medical treatments and lost time at work," stated Raymond J. Hage, Jr., Hapten Science's CEO. "The studies will provide key data on safety and tolerability after one and multiple doses. In addition, the company will collect information on biological activity in preventing contact dermatitis. The company would like to thank ElSohly Laboratories and Mahmoud ElSohly for initially developing the technology and support during preclinical development."
SOURCE Hapten Sciences, Inc.