MEMPHIS, Tenn., Nov. 19, 2015 /PRNewswire/ -- 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."
About Poison Ivy, Sumac, Oak
Allergic contact dermatitis is characterized by a weeping, itchy rash. This allergic reaction is recognized as secondary to exposure to the urushiol oil which is found in poison ivy, poison oak, and poison sumac.
Allergic contact dermatitis is the single most common plant dermatitis in North America. It affects up to 50 million Americans every year, and results in more than 7.1 million office visits and 430,000 hospital outpatients visits each year (CDC Statistics). Approximately 50% to 75% of people are susceptible to contact dermatitis due to urushiol oil, and will develop an allergic reaction when adequately exposed to plants containing it. Furthermore, as little as 50 micrograms of the oil is sufficient to generate dermatitis in 80% to 90% of adults who are exposed.
Individuals at greatest risk for significant morbidity include those who face significant job related exposure (e.g., foresters, firefighters, and farmers) and children who often become sensitized in early childhood. Twenty-five percent of individuals who develop allergic contact dermatitis due to urushiol oil will have severe reactions, with the remaining reactions being either mild or moderate (CDC, 2014).
Treatment for contact dermatitis secondary to urushiol exposure is primarily supportive in nature. Commonly used treatments include calamine lotion, topical hydrocortisone, and antihistamines. Occasionally, with severe reactions, systemic corticosteroids are used (FDA consumer website, 2014). There is currently no preventative treatment for contact dermatitis secondary to urushiol exposure, other than avoidance of exposure (recognition of the plant, wearing gloves, long pants, and long sleeves), skin blocking products, and washing quickly after exposure with soap and water.
About Hapten Sciences, Inc.
Hapten Sciences is a privately held biotechnology company based in Memphis, Tennessee that is pioneering a unique approach to the prevention of contact dermatitis using a small molecule vaccine know as a hapten. Also, Hapten Sciences is reviewing other applications related to this approach for other dermatology conditions. Hapten's lead investor is MB Venture Partners.
SOURCE Hapten Sciences, Inc.